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CONFIDENTIAL — DRAFT 1.0

INFORMED CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY

Protocol Title: A Prospective, Single-Arm, Multicenter Study to Evaluate the Accuracy, Safety, and User Labeling Comprehension of the Solstice Lumina™ Continuous Glucose Monitoring System

Protocol Number: SBD-LUM-CL-001 Short Title: LUMINA-US

This informed consent form has been prepared in accordance with the requirements of 21 C.F.R. Part 50 — Protection of Human Subjects and 21 C.F.R. Part 56 — Institutional Review Boards. This document has been reviewed by the IRB of Record identified above.

[IRB Approval Stamp]

1. INTRODUCTION AND PURPOSE OF THE STUDY

You are being invited to take part in a clinical research study. This informed consent form provides you with important information about the study, including its purpose, the procedures involved, the risks and potential benefits, and your rights as a research participant. Please read this entire form carefully. Take as much time as you need. You are encouraged to discuss this form with your family, friends, or personal healthcare provider if you wish. If there is anything in this form that you do not understand, or if you would like additional information, please ask the study doctor (referred to in this document as the "Principal Investigator" or "study staff") before you make your decision.

Your participation in this study is entirely voluntary. In accordance with 21 C.F.R. § 50.25(a)(8), you may choose not to participate, or you may withdraw from the study at any time, without penalty or loss of benefits to which you are otherwise entitled. Your decision to participate, not to participate, or to withdraw at any time will not affect your current or future medical care, your relationship with your healthcare provider, or your relationship with the study institution.

The purpose of this study is to evaluate the accuracy, safety, and user labeling comprehension of the Solstice Lumina™ Continuous Glucose Monitoring (CGM) System in adults with diabetes mellitus. The Solstice Lumina™ CGM System is a continuous glucose monitoring device that is designed to measure glucose (sugar) levels in the fluid just beneath the skin (called interstitial fluid) on a continuous basis and to display those glucose readings on a small wearable device and on a compatible smartphone application.

The Solstice Lumina™ CGM System is an investigational device. This means that it has not yet been cleared or approved by the United States Food and Drug Administration (FDA) for commercial sale or distribution in the United States. The Lumina CGM System is currently being evaluated in this clinical study to gather data that may be used to support a future regulatory submission to the FDA.

It is important for you to know that the Solstice Lumina™ CGM System has been CE-marked and has been commercially available in the European Union since September 2024. The device received its EU MDR CE Certificate (Certificate No. MCA-2024-07319) on September 12, 2024, issued by the notified body Meridian Conformity Assessment GmbH (Notified Body No. 0483). The European regulatory approval and commercial availability of the device does not constitute FDA clearance or approval, and the regulatory requirements for the United States and the European Union differ.

This study is sponsored by Solstice Biomedical Devices Ltd., an Irish company, and is being conducted through its U.S. subsidiary, Solstice Biomedical Inc., based in Cambridge, Massachusetts. The study is being managed by Veltrano Clinical Research Organization Inc.

The LUMINA-US study is being conducted at approximately six (6) clinical sites across the United States. Approximately 350 participants will be enrolled in the study, consisting of approximately 175 individuals with Type 1 diabetes mellitus and approximately 175 individuals with Type 2 diabetes mellitus. All eligible participants must be aged 18 years or older.

This study is anticipated to qualify for the Investigational Device Exemption (IDE) exemption under 21 C.F.R. § 812.2(c)(3) as a non-significant risk (NSR) diagnostic device study. Under this classification, the study is subject to the abbreviated IDE requirements, which include approval by the IRB of Record and compliance with informed consent requirements and applicable FDA regulations.

2. DESCRIPTION OF THE INVESTIGATIONAL DEVICE

The Solstice Lumina™ CGM System is a continuous glucose monitoring system that consists of two main components that work together to measure and display your glucose levels on a continuous basis. The two components are described below.

Lumina C14 Sensor

The Lumina C14 Sensor is a small sensor that is inserted just under the skin (subcutaneously). It is designed to be worn continuously for up to fourteen (14) days (approximately 336 hours) before it needs to be replaced. The sensor uses a fourth-generation enzymatic electrochemical biosensor with a proprietary platinum-iridium electrode coating, referred to as PtIr-4G technology, to measure glucose levels in the interstitial fluid — the fluid that surrounds the cells in the tissue just beneath your skin. The sensor contains a very thin, flexible filament that sits in the interstitial fluid and reacts with glucose to generate an electrical signal. This electrical signal is proportional to the glucose concentration in the interstitial fluid and is used to calculate a glucose reading.

The Lumina C14 Sensor transmits glucose data wirelessly using Bluetooth Low Energy (BLE) 5.2 technology to the Lumina R7 Reader/Transmitter (described below). The sensor is capable of measuring glucose levels in the range of 40 to 400 mg/dL (milligrams per deciliter). Glucose values that fall below 40 mg/dL or above 400 mg/dL are outside the measurement range of the sensor and will be indicated as "LOW" or "HIGH" on the reader display, respectively.

Lumina R7 Reader/Transmitter

The Lumina R7 Reader/Transmitter is a small, lightweight, wearable device that is worn on the upper arm. The reader receives glucose data from the Lumina C14 Sensor via Bluetooth Low Energy (BLE) wireless communication. The reader features a display screen that shows the following information:

• Real-time glucose values: Your current glucose reading, updated approximately every few minutes.

• Trend arrows: Arrows that indicate the direction and rate of change of your glucose levels (for example, whether your glucose is rising, falling, or remaining relatively stable).

• 8-hour trend graphs: Graphical displays showing your glucose readings over the preceding eight (8) hours, allowing you to see patterns and trends in your glucose levels.

• Configurable alerts: The reader includes customizable alerts for low glucose (hypoglycemia) and high glucose (hyperglycemia). These alert thresholds can be set by you or by your study doctor to help notify you when your glucose levels fall outside your desired range.

The Lumina R7 Reader/Transmitter also communicates with the Solstice Lumina™ mobile application on your compatible smartphone (iOS or Android operating systems) via Bluetooth Low Energy. The mobile application provides additional features for reviewing your glucose data, trends, and alert history.

System Performance Characteristics

The Solstice Lumina™ CGM System provides glucose readings approximately every few minutes on a continuous basis throughout the sensor wear period. The system is designed to have an alert latency — meaning the time from when the sensor takes a glucose reading to when you are notified on the reader or your smartphone — of five (5) minutes or less.

After the Lumina C14 Sensor is first inserted under the skin, the sensor requires a warm-up period of up to sixty (60) minutes before it will begin displaying glucose readings. During this warm-up period, the sensor is stabilizing and calibrating, and no glucose readings will be available. You should continue to use your standard blood glucose monitoring method (finger-stick blood glucose meter) during the warm-up period.

Important: The Solstice Lumina™ CGM System is intended to be used as an adjunct tool for glucose monitoring. This means that the device is designed to supplement, not replace, standard blood glucose monitoring methods. You should not make diabetes treatment decisions — including changes to your insulin doses, meals, or exercise — based solely on the Lumina CGM System readings without first confirming the glucose value with a standard blood glucose meter (finger-stick test) and consulting with your healthcare provider. You should discuss the appropriate use of the device with your study doctor or healthcare provider.

3. STUDY PROCEDURES

If you agree to participate in this study by signing this informed consent form, the following procedures will be performed. This section describes each study visit and the procedures you can expect at each visit.

3.1 Screening Visit

Your first visit will be a screening visit. The purpose of this visit is to determine whether you are eligible to participate in the study. During this visit, the following will occur:

• Review of medical history. The study staff will review your medical history and confirm your diagnosis of diabetes mellitus (Type 1 or Type 2). You will be asked questions about your current diabetes management, including the medications you take, how you currently monitor your blood glucose, and any history of diabetes-related complications.

• Verification of eligibility criteria. The study staff will verify that you meet the study's eligibility criteria, including confirming that you are aged 18 years or older. There are additional inclusion and exclusion criteria that will be reviewed. The study staff will explain these criteria to you and determine your eligibility.

• Physical examination and vital signs. A brief physical examination will be performed, and your vital signs (blood pressure, heart rate, temperature, and respiratory rate) will be measured.

• Review and signing of this informed consent form. You will have the opportunity to read this informed consent form in its entirety, ask any questions, and decide whether you wish to participate. If you agree to participate, you will be asked to sign and date this form. You will receive a signed and dated copy for your records.

3.2 Sensor Insertion and Device Setup

If you are determined to be eligible and you have signed this informed consent form, you will return to the study site for sensor insertion and device setup. During this visit, the following will occur:

• Sensor insertion. A trained study staff member will insert the Lumina C14 Sensor subcutaneously (under the skin), typically in the abdomen or upper arm area. The sensor is inserted using a supplied single-use insertion device that is designed to make the insertion process quick and relatively painless. You may feel a brief pinch or sensation of pressure during insertion. The insertion site will be cleaned and prepared prior to insertion.

• Reader/transmitter placement. The Lumina R7 Reader/Transmitter will be placed on your upper arm and secured in position.

• Training. You will receive training on how to use the Lumina R7 Reader/Transmitter and the Solstice Lumina™ mobile application. This training will cover how to read and interpret glucose readings, understand trend arrows, view 8-hour trend graphs, respond to low glucose and high glucose alerts, and care for the sensor insertion site during the wear period.

• Warm-up period observation. After the sensor is inserted, the sensor requires a warm-up period of up to sixty (60) minutes before glucose readings will be displayed. This warm-up period will be observed at the study site, and the study staff will confirm that the sensor is functioning properly before you leave.

3.3 Sensor Wear Period

After the sensor has been inserted and the warm-up period has been completed, you will wear the Lumina C14 Sensor and Lumina R7 Reader/Transmitter continuously for up to fourteen (14) days. During this sensor wear period, the following will be expected of you:

• Continuous wear. You will be asked to wear the sensor and reader/transmitter continuously for the entire 14-day wear period. You should keep the sensor and reader/transmitter dry and avoid submerging them in water for prolonged periods, unless otherwise instructed by the study staff.

• Finger-stick blood glucose measurements. During the wear period, you will be asked to perform standard finger-stick blood glucose measurements using a reference blood glucose meter provided to you by the study site. These finger-stick measurements are to be performed at specified intervals (as instructed by the study staff) for comparison with the CGM readings from the Lumina system. This comparison is necessary to assess the accuracy of the sensor. The study staff will explain the schedule and technique for performing these measurements.

• Study diary. You will be asked to maintain a study diary throughout the 14-day wear period. In this diary, you will record any symptoms you experience, any sensor alerts you receive, finger-stick glucose values, insulin doses or other diabetes medications taken, meals consumed, and exercise or physical activity. The study staff will provide you with the diary and instructions for completing it.

• Clinic visits during the wear period. You may be asked to visit the study site one or more times during the 14-day sensor wear period for in-clinic accuracy assessments. These visits are described in Section 3.4 below.

3.4 Accuracy Assessment Sessions

During one or more scheduled clinic visits during the sensor wear period, you will undergo glucose monitoring sessions designed to assess the accuracy of the Lumina CGM System. During these sessions:

• Reference laboratory measurements. Your blood glucose will be measured frequently using both the Lumina CGM System (which measures glucose in your interstitial fluid) and a reference laboratory glucose analyzer (such as a YSI glucose analyzer, which measures glucose in your blood). The reference laboratory analyzer is considered the "gold standard" for glucose measurement and will be used as the comparison point for evaluating the accuracy of the Lumina system.

• Glucose manipulation procedures. These sessions may involve procedures to obtain glucose measurements across the full measurement range of the sensor (40 to 400 mg/dL). To achieve this, the sessions may include meal consumption (to raise your blood glucose) or insulin administration (to lower your blood glucose) under close medical supervision. These procedures are designed to allow the study to collect paired glucose measurements (Lumina CGM reading paired with a reference laboratory glucose reading) at various glucose levels, including both low and high glucose levels.

• Venipuncture. During accuracy assessment sessions, blood samples will be drawn from a vein in your arm (venipuncture) or through an intravenous (IV) catheter at frequent intervals for reference glucose analysis. You may experience some discomfort associated with these blood draws.

• Calculation of accuracy. The paired glucose data collected during these sessions will be used to calculate the Mean Absolute Relative Difference (MARD), which is a standard measure of CGM sensor accuracy. The MARD is expressed as a percentage; lower MARD values indicate greater accuracy. The study targets a MARD of less than or equal to 9.0% (≤ 9.0%).

3.5 User Labeling Comprehension Assessment

At a designated time during the study, you will be asked to complete a written questionnaire designed to assess your understanding of the device labeling, instructions for use (IFU), and safety warnings provided with the Solstice Lumina™ CGM System. This questionnaire is part of the study's evaluation of whether the user labeling is clear, understandable, and effective for the intended user population. Completion of this questionnaire is an important study procedure and will take approximately 30 to 45 minutes.

3.6 Sensor Removal and End-of-Study Visit

At the end of the 14-day sensor wear period (or sooner if you withdraw from the study or if the sensor needs to be removed for any reason), you will return to the study site for the following:

• Sensor removal. The Lumina C14 Sensor will be removed by trained study staff. Removal involves gently peeling the sensor adhesive from the skin and withdrawing the sensor filament. You may feel mild discomfort during removal.

• Skin assessment. A brief physical assessment of the sensor insertion site will be performed to check for any skin reactions, irritation, redness, swelling, or other adverse events related to sensor wear.

• Return of study equipment. You will be asked to return all study equipment, including the Lumina C14 Sensor (used), the Lumina R7 Reader/Transmitter, the reference blood glucose meter, and any other supplies provided to you by the study site.

• Study completion procedures. A final study visit will be conducted to confirm your study completion, collect any remaining study data (including your study diary), and address any outstanding questions or concerns.

3.7 Estimated Study Duration

Your individual participation in the LUMINA-US study is expected to last approximately three (3) to four (4) weeks, inclusive of the screening visit, the 14-day sensor wear period, and the end-of-study visit.

The overall duration of the LUMINA-US study across all sites and all participants is estimated to be approximately six (6) months, which includes approximately fourteen (14) weeks of participant enrollment, the 14-day sensor wear period for each participant, and approximately eight (8) weeks of data analysis following the last participant's completion of the study.

The estimated study start date is September 15, 2025, and the estimated study completion date is March 15, 2026. These dates are estimates and may change.

4. RISKS AND DISCOMFORTS

As with any clinical research study and any medical device, there are risks associated with your participation. The known and foreseeable risks and discomforts are described below. You should carefully consider these risks before deciding whether to participate. If you have any questions about the risks described below, please discuss them with the Principal Investigator or study staff.

4.1 Risks Related to the Lumina C14 Sensor Insertion

The insertion of the Lumina C14 Sensor under the skin involves a needle-like insertion device. The following risks are associated with the sensor insertion procedure:

• Pain, discomfort, or tenderness at the insertion site. You may experience mild to moderate pain, discomfort, or tenderness at the site where the sensor is inserted. This is typically temporary and resolves within a few hours to a few days.

• Bleeding or bruising at the insertion site. There may be minor bleeding or bruising at the insertion site after the sensor is placed. This is usually mild and self-resolving.

• Infection at the insertion site. As with any procedure that involves breaking the skin, there is a risk of infection at the sensor insertion site. Signs of infection may include redness, swelling, warmth, drainage of pus, or increased pain at the site. If you notice any of these signs, you should contact the study staff promptly.

• Skin irritation, rash, or allergic reaction. You may experience skin irritation, rash, itching, or an allergic reaction to the sensor adhesive or to the materials used in the sensor, including the proprietary platinum-iridium electrode coating (PtIr-4G technology). If you have a known allergy to adhesives, platinum, iridium, or other metals, you should inform the study staff before the sensor is inserted.

• Scarring at the insertion site. In some cases, mild scarring may occur at the sensor insertion site after the sensor has been removed. This is generally uncommon and usually minor.

• Sensor breakage during insertion or removal. Although rare, there is a risk that the sensor filament could break during insertion or removal. If this occurs, the study staff will take appropriate steps to address the situation, which may include removal of the broken fragment.

4.2 Risks Related to Continuous Sensor Wear

Wearing the Lumina C14 Sensor and Lumina R7 Reader/Transmitter continuously for up to 14 days involves the following risks:

• Skin irritation or contact dermatitis. Prolonged contact with the sensor adhesive or materials during the 14-day wear period may cause skin irritation, contact dermatitis (an inflammatory skin reaction), redness, itching, or discomfort at the sensor site.

• discomfort from continuous wear. You may experience general discomfort from wearing the sensor and reader/transmitter continuously on your body for an extended period.

• Accidental dislodgement of the sensor. The sensor may become accidentally dislodged from the insertion site due to physical activity, clothing, or other factors. If the sensor becomes dislodged, you should contact the study staff for instructions.

• Sensor malfunction leading to inaccurate glucose readings. As with any glucose monitoring device, the Lumina CGM System may occasionally provide inaccurate glucose readings due to sensor malfunction, sensor degradation over time, or other factors. Inaccurate readings could potentially lead to inappropriate diabetes management decisions, such as incorrect insulin dosing, which could result in hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar). This is why the device should be used as an adjunct tool only, and you should confirm glucose readings with a standard finger-stick blood glucose meter before making any treatment decisions.

• False alarms. The system may generate false alarms — that is, hypoglycemia or hyperglycemia alerts that do not correspond to your actual glucose levels. False alarms may cause unnecessary anxiety or lead to inappropriate actions.

• Missed alarms. The system may fail to generate an alert when a genuine hypoglycemia or hyperglycemia event occurs (a "missed alarm"). A missed alarm could result in a delay in recognizing and treating a low or high glucose event, which could have serious health consequences.

4.3 Risks Related to Bluetooth Wireless Communication

The Lumina CGM System uses Bluetooth Low Energy (BLE) wireless technology to transmit data between the sensor and the reader/transmitter, and between the reader/transmitter and your smartphone. The following risks are associated with this wireless communication:

• Signal interference or data transmission interruption. Wireless signals may be subject to interference from other electronic devices or environmental factors, which could temporarily interrupt or delay the transmission of glucose data from the sensor to the reader/transmitter or to your smartphone. During such interruptions, you may not receive real-time glucose readings or alerts.

• Theoretical cybersecurity risks. As with any wireless medical device, there are theoretical cybersecurity risks, including the possibility that unauthorized individuals could attempt to intercept or interfere with the wireless communication between the system components. The Solstice Lumina™ CGM System incorporates encryption and authentication protocols designed to mitigate this risk. However, no wireless system can be guaranteed to be completely secure.

4.4 Risks Related to Accuracy Assessment Sessions

The accuracy assessment sessions described in Section 3.4 involve additional procedures that carry the following risks:

• Pain and bruising from frequent finger-stick blood glucose measurements. You will be required to perform frequent finger-stick blood glucose measurements during the wear period. Repeated finger-sticks can cause pain, soreness, and bruising on your fingertips.

• Risks associated with glucose manipulation procedures. During the accuracy assessment sessions, your blood glucose may be intentionally raised (through meal consumption) or lowered (through insulin administration) under medical supervision to obtain glucose measurements across the full measurement range of the sensor. These glucose manipulation procedures carry a risk of hypoglycemia (low blood sugar), which can cause symptoms such as sweating, shakiness, confusion, dizziness, rapid heartbeat, and in severe cases, loss of consciousness or seizure. They also carry a risk of hyperglycemia (high blood sugar), which can cause symptoms such as increased thirst, frequent urination, fatigue, and blurred vision. These procedures will be performed under close medical supervision, and emergency treatment will be available.

• Risks associated with venipuncture for reference blood draws. Blood samples will be drawn from a vein during accuracy assessment sessions. Venipuncture can cause pain, bruising, swelling, or hematoma at the puncture site. In rare cases, venipuncture can cause infection or nerve damage at the puncture site.

4.5 Risks Related to the PtIr-4G Electrode Coating

The Lumina C14 Sensor uses a proprietary platinum-iridium electrode coating referred to as PtIr-4G technology. Biocompatibility testing of the C14 sensor and its PtIr-4G electrode coating is being conducted in accordance with ISO 10993 standards (Biological Evaluation of Medical Devices) at Whitmore Laboratories Inc., an accredited testing laboratory. The biocompatibility testing program includes the following assessments:

• Cytotoxicity testing

• Sensitization testing

• Irritation testing

• Acute systemic toxicity testing

• Subchronic toxicity testing

• Implantation testing

• Hemocompatibility testing

• Genotoxicity testing

While the platinum-iridium materials used in the electrode coating are expected to be biocompatible based on the well-established use of these materials in medical devices and the testing conducted to date, there is a small risk of unexpected local reactions (such as inflammation, irritation, or allergic reaction at the sensor insertion site) or systemic reactions (reactions affecting the body more broadly) related to the PtIr-4G electrode coating. If you experience any unusual symptoms during the study, you should notify the study staff immediately.

4.6 Unknown Risks

Because the Solstice Lumina™ CGM System is an investigational device, there may be additional risks that are not yet known or anticipated at this time. As with any investigational medical device, the full risk profile of the device may not be completely understood until additional clinical experience is gained. If any new risks or significant findings are identified during the course of the study, you will be notified in a timely manner and given the opportunity to decide whether you wish to continue participating. Please see Section 11 (New Findings) for additional information.

5. POTENTIAL BENEFITS

You may or may not receive a direct personal health benefit from your participation in this study. There is no guarantee that you will personally benefit from participating.

Potential benefits of participating in this study may include:

• Access to continuous glucose monitoring technology. During the study period, you will have access to the Solstice Lumina™ CGM System, which provides continuous glucose readings, trend information, and alerts. This may provide you with additional information about your glucose levels that you may not otherwise have.

• Increased awareness of glucose patterns. By wearing the Lumina CGM System for up to 14 days, you may gain a better understanding of your glucose patterns, including how your glucose levels respond to meals, exercise, medications, and other factors.

• Potential improvement in glucose management. The continuous glucose information and alerts provided by the Lumina CGM System may help you manage your blood glucose levels more effectively during the study period.

• Contribution to medical research. Your participation will contribute to the evaluation of a new CGM system. If the Solstice Lumina™ CGM System is found to be safe and accurate, it may benefit future patients with diabetes by providing an additional option for glucose monitoring.

It is important to understand that these potential benefits are not guaranteed, and the primary purpose of this study is to collect data to evaluate the performance, safety, and labeling comprehension of the investigational device.

6. ALTERNATIVES TO PARTICIPATION

Participation in this study is entirely voluntary. You do not have to participate in this study. If you choose not to participate, or if you choose to withdraw from the study at any time, your decision will not affect your current or future medical care.

As an alternative to participating in this study, you may continue to manage your diabetes using your current glucose monitoring methods, which may include one or more of the following:

• Standard self-monitoring blood glucose (SMBG) meters: Finger-stick blood glucose meters that provide a single blood glucose reading at the time of testing.

• Commercially available CGM systems: There are continuous glucose monitoring systems that have been cleared or approved by the FDA and are commercially available in the United States. Your healthcare provider can discuss these options with you.

• Other methods recommended by your healthcare provider: Your healthcare provider may recommend other glucose monitoring or diabetes management approaches based on your individual medical needs.

You should discuss the alternatives to participation in this study with your healthcare provider before making your decision.

7. CONFIDENTIALITY OF RECORDS

Your identity and personal health information will be kept confidential to the extent permitted by applicable law. The study staff will take steps to protect your privacy and the confidentiality of your study records.

Participant identification. Your study records will be identified by a unique participant identification number rather than by your name. This participant identification number will be used on all study data, forms, and documents to protect your identity. A master list linking your name to your participant identification number will be maintained securely at the study site and will be accessible only to authorized study staff.

Access to your study records. Although your study records are confidential, the following parties may need to review your study records, including portions of your medical records related to this study, for purposes of monitoring, auditing, data verification, and regulatory compliance:

• The sponsor, Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc., and their authorized representatives

• The contract research organization, Veltrano Clinical Research Organization Inc.

• Clearwater Institutional Review Board LLC (IRB Registration No. IRB-2019-04821)

• The U.S. Food and Drug Administration (FDA)

• Other regulatory authorities as required by applicable law

• Calderwood & Harkness LLP (legal counsel to the sponsor) for regulatory compliance purposes

• Pinnacle Regulatory Consulting Group LLC (regulatory consultants to the sponsor)

By signing this informed consent form, you authorize these parties to access your study records and related medical records for the purposes described above.

Publication of results. The results of this study may be published in medical journals, presented at scientific conferences, or included in regulatory submissions. However, your identity will not be disclosed in any publication, presentation, or regulatory submission. Study results will be reported in aggregate or in a de-identified manner so that individual participants cannot be identified.

Data security. Your study data will be stored securely in accordance with applicable federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Electronic data will be stored on secure, access-controlled systems, and paper records will be stored in locked files at the study site. Data will be retained for the period required by applicable regulations.

HIPAA Authorization. A separate HIPAA Authorization form may be provided for your signature. The HIPAA Authorization form describes in greater detail the specific protected health information that will be used and disclosed in connection with this study, the purposes of such use and disclosure, and your rights regarding your protected health information. If a HIPAA Authorization form is provided, you must sign it in order to participate in the study.

8. COSTS AND COMPENSATION

8.1 Costs to You

There will be no cost to you for the investigational device (the Lumina C14 Sensor and the Lumina R7 Reader/Transmitter), study-related procedures, or study visits associated with this study. The sponsor will provide the investigational device and cover the costs of study-specific procedures and visits at no charge to you.

However, you may be responsible for costs related to your routine diabetes care that are not part of this study. Routine care costs include expenses for medications, office visits, laboratory tests, and other healthcare services that you would normally receive as part of your ongoing diabetes management, regardless of your participation in this study. These costs are not covered by the sponsor. You are encouraged to check with your health insurance provider regarding coverage for your routine diabetes care.

8.2 Compensation for Participation

You will receive compensation for your time and travel associated with attending study visits and completing study procedures. The specific amount and schedule of payments will be described in a separate compensation schedule that will be provided to you by your study site. The compensation schedule will outline the payment amount for each study visit, the total potential compensation, and the timing and method of payment.

Compensation will be prorated based on the number of study visits and procedures you complete. This means that if you withdraw from the study before completing all visits and procedures, you will receive compensation only for the visits and procedures you have completed. You will not be penalized or required to return any compensation already received if you choose to withdraw from the study.

9. RESEARCH-RELATED INJURY

If you experience a research-related injury or adverse event that you believe is a result of your participation in this study, whether related to the investigational device or to any study procedure, you should immediately contact the Principal Investigator at the telephone number listed in Section 13 of this form. In case of a medical emergency, you should call 911 or go to the nearest emergency room, and then notify the Principal Investigator as soon as possible.

The sponsor, Solstice Biomedical Devices Ltd. (acting through its U.S. subsidiary Solstice Biomedical Inc.), will provide or pay for the treatment of physical injuries that are directly caused by the investigational device or study procedures, in accordance with applicable law. This commitment applies to injuries that are a direct result of the use of the Solstice Lumina™ CGM System or the performance of study-specific procedures as described in this informed consent form.

The sponsor maintains product liability and clinical trial insurance through Atlas Underwriting Partners Ltd. (Policy No. AUP-PL-2024-00893). This insurance policy provides coverage limits of $25,000,000 (twenty-five million dollars) per occurrence and $50,000,000 (fifty million dollars) in the aggregate, covering U.S. market entry activities, with a policy period of October 1, 2024 through September 30, 2025. The sponsor anticipates renewing or extending this coverage to encompass the full duration of the LUMINA-US study.

Important: This provision does not waive any of your legal rights. Nothing in this informed consent form is intended to release or limit the liability of the sponsor, the study institution, or the investigators for negligence or other wrongful conduct. You do not waive any of your legal rights by signing this consent form.

10. VOLUNTARY PARTICIPATION AND WITHDRAWAL

Your participation in this study is entirely voluntary. You are free to choose whether or not to participate. If you decide not to participate, your decision will not affect your medical care or your relationship with your healthcare provider or the study institution.

If you decide to participate, you may withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled. This right is guaranteed under 21 C.F.R. § 50.25(a)(8). You do not need to provide a reason for withdrawing, although the study staff may ask you about your reason(s) for informational purposes.

How to withdraw. If you decide to withdraw from the study, you should notify the Principal Investigator or study staff as soon as possible. The study staff will arrange for the safe removal of the Lumina C14 Sensor and the return of all study equipment (including the Lumina R7 Reader/Transmitter, the reference blood glucose meter, and any other supplies provided to you). A final skin assessment of the sensor insertion site may be performed to ensure there are no ongoing adverse events.

Effect of withdrawal on medical care. Your decision to withdraw from the study will not affect your current or future medical care or your relationship with your healthcare provider or the study institution. You will continue to receive the same standard of care that you would receive if you had not participated in the study.

Involuntary discontinuation. The Principal Investigator or the sponsor may also discontinue your participation in the study without your consent under certain circumstances, including but not limited to the following:

• The Principal Investigator determines that continued participation is not in your best medical interest (for example, due to a change in your health status, an adverse event, or a safety concern).

• You do not follow the study procedures, instructions, or requirements as described in this informed consent form or as communicated by the study staff.

• The sponsor decides to terminate the study, in whole or at one or more study sites, for any reason.

• The FDA, the IRB of Record, or another regulatory authority requires the termination or suspension of the study.

If your participation is discontinued by the Principal Investigator or the sponsor, you will be informed of the reason(s), and the study staff will arrange for the safe removal of the sensor and return of study equipment.

11. NEW FINDINGS

During the course of this study, new information may become available — from this study or from other sources — that could affect your willingness to continue participating in the study. Such new information might include new findings about the risks or benefits of the Solstice Lumina™ CGM System, new safety information, or changes in the study procedures.

If significant new findings develop during your participation in the LUMINA-US study, you will be informed in a timely manner by the Principal Investigator or study staff. You will be given the opportunity to review this new information and to discuss it with the study staff. You will then have the opportunity to decide whether you wish to continue participating in the study in light of the new information.

If new information requires changes to this informed consent form, you may be asked to review and sign a revised informed consent form that reflects the updated information. Your continued participation in the study after being informed of new findings will be taken as evidence of your willingness to continue, but you will always have the right to withdraw at any time.

12. FDA INSPECTION RIGHTS

By signing this informed consent form, you acknowledge and understand that the U.S. Food and Drug Administration (FDA) has the authority, under applicable federal regulations (including 21 C.F.R. Parts 50, 56, and 812), to inspect and copy study records, including portions of your medical records that are related to this study. The purpose of such inspections is to verify that the study is being conducted in accordance with FDA regulations, that the data collected in the study are accurate and reliable, and that the rights, safety, and welfare of study participants are being adequately protected.

If the FDA conducts an inspection of this study or this study site, the FDA inspectors may review your study records without your additional consent. However, the FDA is required to maintain the confidentiality of your identity and personal health information to the extent permitted by applicable law.

13. CONTACT INFORMATION

13.1 Questions About the Study

If you have any questions about the study, the study procedures, the investigational device, or if you experience a research-related injury or adverse event, please contact the following:

You should contact the Principal Investigator immediately if you experience any of the following during the study: signs of infection at the sensor insertion site (redness, swelling, warmth, drainage), a severe allergic reaction, severe or persistent skin irritation, sensor breakage or malfunction, a serious hypoglycemia or hyperglycemia event, or any other medical emergency or concern related to the study.

13.2 Questions About Your Rights as a Research Participant

If you have any questions about your rights as a research participant, or if you wish to report a concern or complaint about the conduct of this study, you may contact the IRB of Record:

The IRB is an independent committee that reviews and monitors research involving human participants to ensure that the rights and welfare of participants are protected.

13.3 Sponsor Contact Information

If you wish to contact the study sponsor, you may reach:

14. STATEMENT OF CONSENT AND SIGNATURES

14.1 Participant's Statement

I have read this informed consent form in its entirety (or it has been read to me). I have had the opportunity to ask questions about the study, the study procedures, the investigational device, and the risks and benefits of participation. My questions have been answered to my satisfaction by the Principal Investigator or study staff. I have been given sufficient time to consider whether I wish to participate in this study.

I understand that my participation in this study is voluntary, and that I may withdraw from the study at any time, for any reason, without penalty or loss of benefits to which I am otherwise entitled. I understand that my decision to participate or not participate will not affect my current or future medical care.

I voluntarily agree to participate in this research study. I understand that I will receive a signed and dated copy of this informed consent form for my records.

________________________________________

Printed Name of Participant

________________________________________

Signature of Participant

________________________________________

Date

14.2 Person Obtaining Consent

I have explained the research study to the participant named above. I have answered all of the participant's questions to the best of my ability. I believe the participant understands the information described in this informed consent form, including the purpose of the study, the procedures, the risks, the potential benefits, and the alternatives to participation. I believe the participant freely and voluntarily consents to participate in this study.

________________________________________

Printed Name of Person Obtaining Consent

________________________________________

Signature of Person Obtaining Consent

________________________________________

Date

14.3 Principal Investigator (if different from person obtaining consent)

________________________________________

Printed Name of Principal Investigator

CONFIDENTIAL — DRAFT 1.0
INFORMED CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
Protocol Title: A Prospective, Single-Arm, Multicenter Study to Evaluate the Accuracy, Safety, and User Labeling Comprehension of the Solstice Lumina™ Continuous Glucose Monitoring System
Protocol Number: SBD-LUM-CL-001 Short Title: LUMINA-US
This informed consent form has been prepared in accordance with the requirements of 21 C.F.R. Part 50 — Protection of Human Subjects and 21 C.F.R. Part 56 — Institutional Review Boards. This document has been reviewed by the IRB of Record identified above.
[IRB Approval Stamp]
1. INTRODUCTION AND PURPOSE OF THE STUDY
You are being invited to take part in a clinical research study. This informed consent form provides you with important information about the study, including its purpose, the procedures involved, the risks and potential benefits, and your rights as a research participant. Please read this entire form carefully. Take as much time as you need. You are encouraged to discuss this form with your family, friends, or personal healthcare provider if you wish. If there is anything in this form that you do not understand, or if you would like additional information, please ask the study doctor (referred to in this document as the "Principal Investigator" or "study staff") before you make your decision.
Your participation in this study is entirely voluntary. In accordance with 21 C.F.R. § 50.25(a)(8), you may choose not to participate, or you may withdraw from the study at any time, without penalty or loss of benefits to which you are otherwise entitled. Your decision to participate, not to participate, or to withdraw at any time will not affect your current or future medical care, your relationship with your healthcare provider, or your relationship with the study institution.
The purpose of this study is to evaluate the accuracy, safety, and user labeling comprehension of the Solstice Lumina™ Continuous Glucose Monitoring (CGM) System in adults with diabetes mellitus. The Solstice Lumina™ CGM System is a continuous glucose monitoring device that is designed to measure glucose (sugar) levels in the fluid just beneath the skin (called interstitial fluid) on a continuous basis and to display those glucose readings on a small wearable device and on a compatible smartphone application.
The Solstice Lumina™ CGM System is an investigational device. This means that it has not yet been cleared or approved by the United States Food and Drug Administration (FDA) for commercial sale or distribution in the United States. The Lumina CGM System is currently being evaluated in this clinical study to gather data that may be used to support a future regulatory submission to the FDA.
It is important for you to know that the Solstice Lumina™ CGM System has been CE-marked and has been commercially available in the European Union since September 2024. The device received its EU MDR CE Certificate (Certificate No. MCA-2024-07319) on September 12, 2024, issued by the notified body Meridian Conformity Assessment GmbH (Notified Body No. 0483). The European regulatory approval and commercial availability of the device does not constitute FDA clearance or approval, and the regulatory requirements for the United States and the European Union differ.
This study is sponsored by Solstice Biomedical Devices Ltd., an Irish company, and is being conducted through its U.S. subsidiary, Solstice Biomedical Inc., based in Cambridge, Massachusetts. The study is being managed by Veltrano Clinical Research Organization Inc.
The LUMINA-US study is being conducted at approximately six (6) clinical sites across the United States. Approximately 350 participants will be enrolled in the study, consisting of approximately 175 individuals with Type 1 diabetes mellitus and approximately 175 individuals with Type 2 diabetes mellitus. All eligible participants must be aged 18 years or older.
This study is anticipated to qualify for the Investigational Device Exemption (IDE) exemption under 21 C.F.R. § 812.2(c)(3) as a non-significant risk (NSR) diagnostic device study. Under this classification, the study is subject to the abbreviated IDE requirements, which include approval by the IRB of Record and compliance with informed consent requirements and applicable FDA regulations.
2. DESCRIPTION OF THE INVESTIGATIONAL DEVICE
The Solstice Lumina™ CGM System is a continuous glucose monitoring system that consists of two main components that work together to measure and display your glucose levels on a continuous basis. The two components are described below.
Lumina C14 Sensor
The Lumina C14 Sensor is a small sensor that is inserted just under the skin (subcutaneously). It is designed to be worn continuously for up to fourteen (14) days (approximately 336 hours) before it needs to be replaced. The sensor uses a fourth-generation enzymatic electrochemical biosensor with a proprietary platinum-iridium electrode coating, referred to as PtIr-4G technology, to measure glucose levels in the interstitial fluid — the fluid that surrounds the cells in the tissue just beneath your skin. The sensor contains a very thin, flexible filament that sits in the interstitial fluid and reacts with glucose to generate an electrical signal. This electrical signal is proportional to the glucose concentration in the interstitial fluid and is used to calculate a glucose reading.
The Lumina C14 Sensor transmits glucose data wirelessly using Bluetooth Low Energy (BLE) 5.2 technology to the Lumina R7 Reader/Transmitter (described below). The sensor is capable of measuring glucose levels in the range of 40 to 400 mg/dL (milligrams per deciliter). Glucose values that fall below 40 mg/dL or above 400 mg/dL are outside the measurement range of the sensor and will be indicated as "LOW" or "HIGH" on the reader display, respectively.
Lumina R7 Reader/Transmitter
The Lumina R7 Reader/Transmitter is a small, lightweight, wearable device that is worn on the upper arm. The reader receives glucose data from the Lumina C14 Sensor via Bluetooth Low Energy (BLE) wireless communication. The reader features a display screen that shows the following information:
•  Real-time glucose values: Your current glucose reading, updated approximately every few minutes.
•  Trend arrows: Arrows that indicate the direction and rate of change of your glucose levels (for example, whether your glucose is rising, falling, or remaining relatively stable).
•  8-hour trend graphs: Graphical displays showing your glucose readings over the preceding eight (8) hours, allowing you to see patterns and trends in your glucose levels.
•  Configurable alerts: The reader includes customizable alerts for low glucose (hypoglycemia) and high glucose (hyperglycemia). These alert thresholds can be set by you or by your study doctor to help notify you when your glucose levels fall outside your desired range.
The Lumina R7 Reader/Transmitter also communicates with the Solstice Lumina™ mobile application on your compatible smartphone (iOS or Android operating systems) via Bluetooth Low Energy. The mobile application provides additional features for reviewing your glucose data, trends, and alert history.
System Performance Characteristics
The Solstice Lumina™ CGM System provides glucose readings approximately every few minutes on a continuous basis throughout the sensor wear period. The system is designed to have an alert latency — meaning the time from when the sensor takes a glucose reading to when you are notified on the reader or your smartphone — of five (5) minutes or less.
After the Lumina C14 Sensor is first inserted under the skin, the sensor requires a warm-up period of up to sixty (60) minutes before it will begin displaying glucose readings. During this warm-up period, the sensor is stabilizing and calibrating, and no glucose readings will be available. You should continue to use your standard blood glucose monitoring method (finger-stick blood glucose meter) during the warm-up period.
Important: The Solstice Lumina™ CGM System is intended to be used as an adjunct tool for glucose monitoring. This means that the device is designed to supplement, not replace, standard blood glucose monitoring methods. You should not make diabetes treatment decisions — including changes to your insulin doses, meals, or exercise — based solely on the Lumina CGM System readings without first confirming the glucose value with a standard blood glucose meter (finger-stick test) and consulting with your healthcare provider. You should discuss the appropriate use of the device with your study doctor or healthcare provider.
3. STUDY PROCEDURES
If you agree to participate in this study by signing this informed consent form, the following procedures will be performed. This section describes each study visit and the procedures you can expect at each visit.
3.1 Screening Visit
Your first visit will be a screening visit. The purpose of this visit is to determine whether you are eligible to participate in the study. During this visit, the following will occur:
•  Review of medical history. The study staff will review your medical history and confirm your diagnosis of diabetes mellitus (Type 1 or Type 2). You will be asked questions about your current diabetes management, including the medications you take, how you currently monitor your blood glucose, and any history of diabetes-related complications.
•  Verification of eligibility criteria. The study staff will verify that you meet the study's eligibility criteria, including confirming that you are aged 18 years or older. There are additional inclusion and exclusion criteria that will be reviewed. The study staff will explain these criteria to you and determine your eligibility.
•  Physical examination and vital signs. A brief physical examination will be performed, and your vital signs (blood pressure, heart rate, temperature, and respiratory rate) will be measured.
•  Review and signing of this informed consent form. You will have the opportunity to read this informed consent form in its entirety, ask any questions, and decide whether you wish to participate. If you agree to participate, you will be asked to sign and date this form. You will receive a signed and dated copy for your records.
3.2 Sensor Insertion and Device Setup
If you are determined to be eligible and you have signed this informed consent form, you will return to the study site for sensor insertion and device setup. During this visit, the following will occur:
•  Sensor insertion. A trained study staff member will insert the Lumina C14 Sensor subcutaneously (under the skin), typically in the abdomen or upper arm area. The sensor is inserted using a supplied single-use insertion device that is designed to make the insertion process quick and relatively painless. You may feel a brief pinch or sensation of pressure during insertion. The insertion site will be cleaned and prepared prior to insertion.
•  Reader/transmitter placement. The Lumina R7 Reader/Transmitter will be placed on your upper arm and secured in position.
•  Training. You will receive training on how to use the Lumina R7 Reader/Transmitter and the Solstice Lumina™ mobile application. This training will cover how to read and interpret glucose readings, understand trend arrows, view 8-hour trend graphs, respond to low glucose and high glucose alerts, and care for the sensor insertion site during the wear period.
•  Warm-up period observation. After the sensor is inserted, the sensor requires a warm-up period of up to sixty (60) minutes before glucose readings will be displayed. This warm-up period will be observed at the study site, and the study staff will confirm that the sensor is functioning properly before you leave.
3.3 Sensor Wear Period
After the sensor has been inserted and the warm-up period has been completed, you will wear the Lumina C14 Sensor and Lumina R7 Reader/Transmitter continuously for up to fourteen (14) days. During this sensor wear period, the following will be expected of you:
•  Continuous wear. You will be asked to wear the sensor and reader/transmitter continuously for the entire 14-day wear period. You should keep the sensor and reader/transmitter dry and avoid submerging them in water for prolonged periods, unless otherwise instructed by the study staff.
•  Finger-stick blood glucose measurements. During the wear period, you will be asked to perform standard finger-stick blood glucose measurements using a reference blood glucose meter provided to you by the study site. These finger-stick measurements are to be performed at specified intervals (as instructed by the study staff) for comparison with the CGM readings from the Lumina system. This comparison is necessary to assess the accuracy of the sensor. The study staff will explain the schedule and technique for performing these measurements.
•  Study diary. You will be asked to maintain a study diary throughout the 14-day wear period. In this diary, you will record any symptoms you experience, any sensor alerts you receive, finger-stick glucose values, insulin doses or other diabetes medications taken, meals consumed, and exercise or physical activity. The study staff will provide you with the diary and instructions for completing it.
•  Clinic visits during the wear period. You may be asked to visit the study site one or more times during the 14-day sensor wear period for in-clinic accuracy assessments. These visits are described in Section 3.4 below.
3.4 Accuracy Assessment Sessions
During one or more scheduled clinic visits during the sensor wear period, you will undergo glucose monitoring sessions designed to assess the accuracy of the Lumina CGM System. During these sessions:
•  Reference laboratory measurements. Your blood glucose will be measured frequently using both the Lumina CGM System (which measures glucose in your interstitial fluid) and a reference laboratory glucose analyzer (such as a YSI glucose analyzer, which measures glucose in your blood). The reference laboratory analyzer is considered the "gold standard" for glucose measurement and will be used as the comparison point for evaluating the accuracy of the Lumina system.
•  Glucose manipulation procedures. These sessions may involve procedures to obtain glucose measurements across the full measurement range of the sensor (40 to 400 mg/dL). To achieve this, the sessions may include meal consumption (to raise your blood glucose) or insulin administration (to lower your blood glucose) under close medical supervision. These procedures are designed to allow the study to collect paired glucose measurements (Lumina CGM reading paired with a reference laboratory glucose reading) at various glucose levels, including both low and high glucose levels.
•  Venipuncture. During accuracy assessment sessions, blood samples will be drawn from a vein in your arm (venipuncture) or through an intravenous (IV) catheter at frequent intervals for reference glucose analysis. You may experience some discomfort associated with these blood draws.
•  Calculation of accuracy. The paired glucose data collected during these sessions will be used to calculate the Mean Absolute Relative Difference (MARD), which is a standard measure of CGM sensor accuracy. The MARD is expressed as a percentage; lower MARD values indicate greater accuracy. The study targets a MARD of less than or equal to 9.0% (≤ 9.0%).
3.5 User Labeling Comprehension Assessment
At a designated time during the study, you will be asked to complete a written questionnaire designed to assess your understanding of the device labeling, instructions for use (IFU), and safety warnings provided with the Solstice Lumina™ CGM System. This questionnaire is part of the study's evaluation of whether the user labeling is clear, understandable, and effective for the intended user population. Completion of this questionnaire is an important study procedure and will take approximately 30 to 45 minutes.
3.6 Sensor Removal and End-of-Study Visit
At the end of the 14-day sensor wear period (or sooner if you withdraw from the study or if the sensor needs to be removed for any reason), you will return to the study site for the following:
•  Sensor removal. The Lumina C14 Sensor will be removed by trained study staff. Removal involves gently peeling the sensor adhesive from the skin and withdrawing the sensor filament. You may feel mild discomfort during removal.
•  Skin assessment. A brief physical assessment of the sensor insertion site will be performed to check for any skin reactions, irritation, redness, swelling, or other adverse events related to sensor wear.
•  Return of study equipment. You will be asked to return all study equipment, including the Lumina C14 Sensor (used), the Lumina R7 Reader/Transmitter, the reference blood glucose meter, and any other supplies provided to you by the study site.
•  Study completion procedures. A final study visit will be conducted to confirm your study completion, collect any remaining study data (including your study diary), and address any outstanding questions or concerns.
3.7 Estimated Study Duration
Your individual participation in the LUMINA-US study is expected to last approximately three (3) to four (4) weeks, inclusive of the screening visit, the 14-day sensor wear period, and the end-of-study visit.
The overall duration of the LUMINA-US study across all sites and all participants is estimated to be approximately six (6) months, which includes approximately fourteen (14) weeks of participant enrollment, the 14-day sensor wear period for each participant, and approximately eight (8) weeks of data analysis following the last participant's completion of the study.
The estimated study start date is September 15, 2025, and the estimated study completion date is March 15, 2026. These dates are estimates and may change.
4. RISKS AND DISCOMFORTS
As with any clinical research study and any medical device, there are risks associated with your participation. The known and foreseeable risks and discomforts are described below. You should carefully consider these risks before deciding whether to participate. If you have any questions about the risks described below, please discuss them with the Principal Investigator or study staff.
4.1 Risks Related to the Lumina C14 Sensor Insertion
The insertion of the Lumina C14 Sensor under the skin involves a needle-like insertion device. The following risks are associated with the sensor insertion procedure:
•  Pain, discomfort, or tenderness at the insertion site. You may experience mild to moderate pain, discomfort, or tenderness at the site where the sensor is inserted. This is typically temporary and resolves within a few hours to a few days.
•  Bleeding or bruising at the insertion site. There may be minor bleeding or bruising at the insertion site after the sensor is placed. This is usually mild and self-resolving.
•  Infection at the insertion site. As with any procedure that involves breaking the skin, there is a risk of infection at the sensor insertion site. Signs of infection may include redness, swelling, warmth, drainage of pus, or increased pain at the site. If you notice any of these signs, you should contact the study staff promptly.
•  Skin irritation, rash, or allergic reaction. You may experience skin irritation, rash, itching, or an allergic reaction to the sensor adhesive or to the materials used in the sensor, including the proprietary platinum-iridium electrode coating (PtIr-4G technology). If you have a known allergy to adhesives, platinum, iridium, or other metals, you should inform the study staff before the sensor is inserted.
•  Scarring at the insertion site. In some cases, mild scarring may occur at the sensor insertion site after the sensor has been removed. This is generally uncommon and usually minor.
•  Sensor breakage during insertion or removal. Although rare, there is a risk that the sensor filament could break during insertion or removal. If this occurs, the study staff will take appropriate steps to address the situation, which may include removal of the broken fragment.
4.2 Risks Related to Continuous Sensor Wear
Wearing the Lumina C14 Sensor and Lumina R7 Reader/Transmitter continuously for up to 14 days involves the following risks:
•  Skin irritation or contact dermatitis. Prolonged contact with the sensor adhesive or materials during the 14-day wear period may cause skin irritation, contact dermatitis (an inflammatory skin reaction), redness, itching, or discomfort at the sensor site.
•  discomfort from continuous wear. You may experience general discomfort from wearing the sensor and reader/transmitter continuously on your body for an extended period.
•  Accidental dislodgement of the sensor. The sensor may become accidentally dislodged from the insertion site due to physical activity, clothing, or other factors. If the sensor becomes dislodged, you should contact the study staff for instructions.
•  Sensor malfunction leading to inaccurate glucose readings. As with any glucose monitoring device, the Lumina CGM System may occasionally provide inaccurate glucose readings due to sensor malfunction, sensor degradation over time, or other factors. Inaccurate readings could potentially lead to inappropriate diabetes management decisions, such as incorrect insulin dosing, which could result in hypoglycemia (dangerously low blood sugar) or hyperglycemia (dangerously high blood sugar). This is why the device should be used as an adjunct tool only, and you should confirm glucose readings with a standard finger-stick blood glucose meter before making any treatment decisions.
•  False alarms. The system may generate false alarms — that is, hypoglycemia or hyperglycemia alerts that do not correspond to your actual glucose levels. False alarms may cause unnecessary anxiety or lead to inappropriate actions.
•  Missed alarms. The system may fail to generate an alert when a genuine hypoglycemia or hyperglycemia event occurs (a "missed alarm"). A missed alarm could result in a delay in recognizing and treating a low or high glucose event, which could have serious health consequences.
4.3 Risks Related to Bluetooth Wireless Communication
The Lumina CGM System uses Bluetooth Low Energy (BLE) wireless technology to transmit data between the sensor and the reader/transmitter, and between the reader/transmitter and your smartphone. The following risks are associated with this wireless communication:
•  Signal interference or data transmission interruption. Wireless signals may be subject to interference from other electronic devices or environmental factors, which could temporarily interrupt or delay the transmission of glucose data from the sensor to the reader/transmitter or to your smartphone. During such interruptions, you may not receive real-time glucose readings or alerts.
•  Theoretical cybersecurity risks. As with any wireless medical device, there are theoretical cybersecurity risks, including the possibility that unauthorized individuals could attempt to intercept or interfere with the wireless communication between the system components. The Solstice Lumina™ CGM System incorporates encryption and authentication protocols designed to mitigate this risk. However, no wireless system can be guaranteed to be completely secure.
4.4 Risks Related to Accuracy Assessment Sessions
The accuracy assessment sessions described in Section 3.4 involve additional procedures that carry the following risks:
•  Pain and bruising from frequent finger-stick blood glucose measurements. You will be required to perform frequent finger-stick blood glucose measurements during the wear period. Repeated finger-sticks can cause pain, soreness, and bruising on your fingertips.
•  Risks associated with glucose manipulation procedures. During the accuracy assessment sessions, your blood glucose may be intentionally raised (through meal consumption) or lowered (through insulin administration) under medical supervision to obtain glucose measurements across the full measurement range of the sensor. These glucose manipulation procedures carry a risk of hypoglycemia (low blood sugar), which can cause symptoms such as sweating, shakiness, confusion, dizziness, rapid heartbeat, and in severe cases, loss of consciousness or seizure. They also carry a risk of hyperglycemia (high blood sugar), which can cause symptoms such as increased thirst, frequent urination, fatigue, and blurred vision. These procedures will be performed under close medical supervision, and emergency treatment will be available.
•  Risks associated with venipuncture for reference blood draws. Blood samples will be drawn from a vein during accuracy assessment sessions. Venipuncture can cause pain, bruising, swelling, or hematoma at the puncture site. In rare cases, venipuncture can cause infection or nerve damage at the puncture site.
4.5 Risks Related to the PtIr-4G Electrode Coating
The Lumina C14 Sensor uses a proprietary platinum-iridium electrode coating referred to as PtIr-4G technology. Biocompatibility testing of the C14 sensor and its PtIr-4G electrode coating is being conducted in accordance with ISO 10993 standards (Biological Evaluation of Medical Devices) at Whitmore Laboratories Inc., an accredited testing laboratory. The biocompatibility testing program includes the following assessments:
•  Cytotoxicity testing
•  Sensitization testing
•  Irritation testing
•  Acute systemic toxicity testing
•  Subchronic toxicity testing
•  Implantation testing
•  Hemocompatibility testing
•  Genotoxicity testing
While the platinum-iridium materials used in the electrode coating are expected to be biocompatible based on the well-established use of these materials in medical devices and the testing conducted to date, there is a small risk of unexpected local reactions (such as inflammation, irritation, or allergic reaction at the sensor insertion site) or systemic reactions (reactions affecting the body more broadly) related to the PtIr-4G electrode coating. If you experience any unusual symptoms during the study, you should notify the study staff immediately.
4.6 Unknown Risks
Because the Solstice Lumina™ CGM System is an investigational device, there may be additional risks that are not yet known or anticipated at this time. As with any investigational medical device, the full risk profile of the device may not be completely understood until additional clinical experience is gained. If any new risks or significant findings are identified during the course of the study, you will be notified in a timely manner and given the opportunity to decide whether you wish to continue participating. Please see Section 11 (New Findings) for additional information.
5. POTENTIAL BENEFITS
You may or may not receive a direct personal health benefit from your participation in this study. There is no guarantee that you will personally benefit from participating.
Potential benefits of participating in this study may include:
•  Access to continuous glucose monitoring technology. During the study period, you will have access to the Solstice Lumina™ CGM System, which provides continuous glucose readings, trend information, and alerts. This may provide you with additional information about your glucose levels that you may not otherwise have.
•  Increased awareness of glucose patterns. By wearing the Lumina CGM System for up to 14 days, you may gain a better understanding of your glucose patterns, including how your glucose levels respond to meals, exercise, medications, and other factors.
•  Potential improvement in glucose management. The continuous glucose information and alerts provided by the Lumina CGM System may help you manage your blood glucose levels more effectively during the study period.
•  Contribution to medical research. Your participation will contribute to the evaluation of a new CGM system. If the Solstice Lumina™ CGM System is found to be safe and accurate, it may benefit future patients with diabetes by providing an additional option for glucose monitoring.
It is important to understand that these potential benefits are not guaranteed, and the primary purpose of this study is to collect data to evaluate the performance, safety, and labeling comprehension of the investigational device.
6. ALTERNATIVES TO PARTICIPATION
Participation in this study is entirely voluntary. You do not have to participate in this study. If you choose not to participate, or if you choose to withdraw from the study at any time, your decision will not affect your current or future medical care.
As an alternative to participating in this study, you may continue to manage your diabetes using your current glucose monitoring methods, which may include one or more of the following:
•  Standard self-monitoring blood glucose (SMBG) meters: Finger-stick blood glucose meters that provide a single blood glucose reading at the time of testing.
•  Commercially available CGM systems: There are continuous glucose monitoring systems that have been cleared or approved by the FDA and are commercially available in the United States. Your healthcare provider can discuss these options with you.
•  Other methods recommended by your healthcare provider: Your healthcare provider may recommend other glucose monitoring or diabetes management approaches based on your individual medical needs.
You should discuss the alternatives to participation in this study with your healthcare provider before making your decision.
7. CONFIDENTIALITY OF RECORDS
Your identity and personal health information will be kept confidential to the extent permitted by applicable law. The study staff will take steps to protect your privacy and the confidentiality of your study records.
Participant identification. Your study records will be identified by a unique participant identification number rather than by your name. This participant identification number will be used on all study data, forms, and documents to protect your identity. A master list linking your name to your participant identification number will be maintained securely at the study site and will be accessible only to authorized study staff.
Access to your study records. Although your study records are confidential, the following parties may need to review your study records, including portions of your medical records related to this study, for purposes of monitoring, auditing, data verification, and regulatory compliance:
•  The sponsor, Solstice Biomedical Devices Ltd. and Solstice Biomedical Inc., and their authorized representatives
•  The contract research organization, Veltrano Clinical Research Organization Inc.
•  Clearwater Institutional Review Board LLC (IRB Registration No. IRB-2019-04821)
•  The U.S. Food and Drug Administration (FDA)
•  Other regulatory authorities as required by applicable law
•  Calderwood & Harkness LLP (legal counsel to the sponsor) for regulatory compliance purposes
•  Pinnacle Regulatory Consulting Group LLC (regulatory consultants to the sponsor)
By signing this informed consent form, you authorize these parties to access your study records and related medical records for the purposes described above.
Publication of results. The results of this study may be published in medical journals, presented at scientific conferences, or included in regulatory submissions. However, your identity will not be disclosed in any publication, presentation, or regulatory submission. Study results will be reported in aggregate or in a de-identified manner so that individual participants cannot be identified.
Data security. Your study data will be stored securely in accordance with applicable federal and state privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). Electronic data will be stored on secure, access-controlled systems, and paper records will be stored in locked files at the study site. Data will be retained for the period required by applicable regulations.
HIPAA Authorization. A separate HIPAA Authorization form may be provided for your signature. The HIPAA Authorization form describes in greater detail the specific protected health information that will be used and disclosed in connection with this study, the purposes of such use and disclosure, and your rights regarding your protected health information. If a HIPAA Authorization form is provided, you must sign it in order to participate in the study.
8. COSTS AND COMPENSATION
8.1 Costs to You
There will be no cost to you for the investigational device (the Lumina C14 Sensor and the Lumina R7 Reader/Transmitter), study-related procedures, or study visits associated with this study. The sponsor will provide the investigational device and cover the costs of study-specific procedures and visits at no charge to you.
However, you may be responsible for costs related to your routine diabetes care that are not part of this study. Routine care costs include expenses for medications, office visits, laboratory tests, and other healthcare services that you would normally receive as part of your ongoing diabetes management, regardless of your participation in this study. These costs are not covered by the sponsor. You are encouraged to check with your health insurance provider regarding coverage for your routine diabetes care.
8.2 Compensation for Participation
You will receive compensation for your time and travel associated with attending study visits and completing study procedures. The specific amount and schedule of payments will be described in a separate compensation schedule that will be provided to you by your study site. The compensation schedule will outline the payment amount for each study visit, the total potential compensation, and the timing and method of payment.
Compensation will be prorated based on the number of study visits and procedures you complete. This means that if you withdraw from the study before completing all visits and procedures, you will receive compensation only for the visits and procedures you have completed. You will not be penalized or required to return any compensation already received if you choose to withdraw from the study.
9. RESEARCH-RELATED INJURY
If you experience a research-related injury or adverse event that you believe is a result of your participation in this study, whether related to the investigational device or to any study procedure, you should immediately contact the Principal Investigator at the telephone number listed in Section 13 of this form. In case of a medical emergency, you should call 911 or go to the nearest emergency room, and then notify the Principal Investigator as soon as possible.
The sponsor, Solstice Biomedical Devices Ltd. (acting through its U.S. subsidiary Solstice Biomedical Inc.), will provide or pay for the treatment of physical injuries that are directly caused by the investigational device or study procedures, in accordance with applicable law. This commitment applies to injuries that are a direct result of the use of the Solstice Lumina™ CGM System or the performance of study-specific procedures as described in this informed consent form.
The sponsor maintains product liability and clinical trial insurance through Atlas Underwriting Partners Ltd. (Policy No. AUP-PL-2024-00893). This insurance policy provides coverage limits of $25,000,000 (twenty-five million dollars) per occurrence and $50,000,000 (fifty million dollars) in the aggregate, covering U.S. market entry activities, with a policy period of October 1, 2024 through September 30, 2025. The sponsor anticipates renewing or extending this coverage to encompass the full duration of the LUMINA-US study.
Important: This provision does not waive any of your legal rights. Nothing in this informed consent form is intended to release or limit the liability of the sponsor, the study institution, or the investigators for negligence or other wrongful conduct. You do not waive any of your legal rights by signing this consent form.
10. VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is entirely voluntary. You are free to choose whether or not to participate. If you decide not to participate, your decision will not affect your medical care or your relationship with your healthcare provider or the study institution.
If you decide to participate, you may withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled. This right is guaranteed under 21 C.F.R. § 50.25(a)(8). You do not need to provide a reason for withdrawing, although the study staff may ask you about your reason(s) for informational purposes.
How to withdraw. If you decide to withdraw from the study, you should notify the Principal Investigator or study staff as soon as possible. The study staff will arrange for the safe removal of the Lumina C14 Sensor and the return of all study equipment (including the Lumina R7 Reader/Transmitter, the reference blood glucose meter, and any other supplies provided to you). A final skin assessment of the sensor insertion site may be performed to ensure there are no ongoing adverse events.
Effect of withdrawal on medical care. Your decision to withdraw from the study will not affect your current or future medical care or your relationship with your healthcare provider or the study institution. You will continue to receive the same standard of care that you would receive if you had not participated in the study.
Involuntary discontinuation. The Principal Investigator or the sponsor may also discontinue your participation in the study without your consent under certain circumstances, including but not limited to the following:
•  The Principal Investigator determines that continued participation is not in your best medical interest (for example, due to a change in your health status, an adverse event, or a safety concern).
•  You do not follow the study procedures, instructions, or requirements as described in this informed consent form or as communicated by the study staff.
•  The sponsor decides to terminate the study, in whole or at one or more study sites, for any reason.
•  The FDA, the IRB of Record, or another regulatory authority requires the termination or suspension of the study.
If your participation is discontinued by the Principal Investigator or the sponsor, you will be informed of the reason(s), and the study staff will arrange for the safe removal of the sensor and return of study equipment.
11. NEW FINDINGS
During the course of this study, new information may become available — from this study or from other sources — that could affect your willingness to continue participating in the study. Such new information might include new findings about the risks or benefits of the Solstice Lumina™ CGM System, new safety information, or changes in the study procedures.
If significant new findings develop during your participation in the LUMINA-US study, you will be informed in a timely manner by the Principal Investigator or study staff. You will be given the opportunity to review this new information and to discuss it with the study staff. You will then have the opportunity to decide whether you wish to continue participating in the study in light of the new information.
If new information requires changes to this informed consent form, you may be asked to review and sign a revised informed consent form that reflects the updated information. Your continued participation in the study after being informed of new findings will be taken as evidence of your willingness to continue, but you will always have the right to withdraw at any time.
12. FDA INSPECTION RIGHTS
By signing this informed consent form, you acknowledge and understand that the U.S. Food and Drug Administration (FDA) has the authority, under applicable federal regulations (including 21 C.F.R. Parts 50, 56, and 812), to inspect and copy study records, including portions of your medical records that are related to this study. The purpose of such inspections is to verify that the study is being conducted in accordance with FDA regulations, that the data collected in the study are accurate and reliable, and that the rights, safety, and welfare of study participants are being adequately protected.
If the FDA conducts an inspection of this study or this study site, the FDA inspectors may review your study records without your additional consent. However, the FDA is required to maintain the confidentiality of your identity and personal health information to the extent permitted by applicable law.
13. CONTACT INFORMATION
13.1 Questions About the Study
If you have any questions about the study, the study procedures, the investigational device, or if you experience a research-related injury or adverse event, please contact the following:
You should contact the Principal Investigator immediately if you experience any of the following during the study: signs of infection at the sensor insertion site (redness, swelling, warmth, drainage), a severe allergic reaction, severe or persistent skin irritation, sensor breakage or malfunction, a serious hypoglycemia or hyperglycemia event, or any other medical emergency or concern related to the study.
13.2 Questions About Your Rights as a Research Participant
If you have any questions about your rights as a research participant, or if you wish to report a concern or complaint about the conduct of this study, you may contact the IRB of Record:
The IRB is an independent committee that reviews and monitors research involving human participants to ensure that the rights and welfare of participants are protected.
13.3 Sponsor Contact Information
If you wish to contact the study sponsor, you may reach:
14. STATEMENT OF CONSENT AND SIGNATURES
14.1 Participant's Statement
I have read this informed consent form in its entirety (or it has been read to me). I have had the opportunity to ask questions about the study, the study procedures, the investigational device, and the risks and benefits of participation. My questions have been answered to my satisfaction by the Principal Investigator or study staff. I have been given sufficient time to consider whether I wish to participate in this study.
I understand that my participation in this study is voluntary, and that I may withdraw from the study at any time, for any reason, without penalty or loss of benefits to which I am otherwise entitled. I understand that my decision to participate or not participate will not affect my current or future medical care.
I voluntarily agree to participate in this research study. I understand that I will receive a signed and dated copy of this informed consent form for my records.
________________________________________
Printed Name of Participant
________________________________________
Signature of Participant
________________________________________
Date
14.2 Person Obtaining Consent
I have explained the research study to the participant named above. I have answered all of the participant's questions to the best of my ability. I believe the participant understands the information described in this informed consent form, including the purpose of the study, the procedures, the risks, the potential benefits, and the alternatives to participation. I believe the participant freely and voluntarily consents to participate in this study.
________________________________________
Printed Name of Person Obtaining Consent
________________________________________
Signature of Person Obtaining Consent
________________________________________
Date
14.3 Principal Investigator (if different from person obtaining consent)
________________________________________
Printed Name of Principal Investigator
________________________________________
Signature of Principal Investigator
________________________________________
Date
14.4 Witness (if applicable)
A witness signature is required if this informed consent form was read to the participant (for example, if the participant is unable to read). The witness attests that the informed consent process was conducted appropriately, that the consent form was accurately read to the participant, that the participant had the opportunity to ask questions, and that the participant appeared to freely give consent.
________________________________________
Printed Name of Witness
________________________________________
Signature of Witness
________________________________________
Date
Protocol No.: SBD-LUM-CL-001 | Document Version: Draft 1.0 | LUMINA-US Informed Consent Form
This document is confidential and is the property of Solstice Biomedical Devices Ltd. Unauthorized use, disclosure, or reproduction is prohibited.
[IRB Approval Stamp]
Sponsor: | Solstice Biomedical Devices Ltd., Unit 14, Liffey Innovation Park, Chapelizod, Dublin D20 FX72, Ireland; acting through its U.S. subsidiary Solstice Biomedical Inc., 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
Sponsor's VP of Regulatory Affairs: | Dr. Niamh Tierney, RAC
Institutional Review Board (IRB) of Record: | Clearwater Institutional Review Board LLC, 3200 Bayshore Boulevard, Tampa, FL 33629; IRB Registration No. IRB-2019-04821
Contract Research Organization: | Veltrano Clinical Research Organization Inc., 500 North Capitol Street, Suite 700, Indianapolis, IN 46204
Document Version: | Draft 1.0
Date: | [To be dated upon finalization — approximately May 2025]
Prepared by: | Calderwood & Harkness LLP, 1401 K Street NW, Suite 900, Washington, D.C. 20005; Amy Whitfield, Lead Associate, Healthcare & Life Sciences Practice
Principal Investigator: | __________
Principal Investigator Telephone: | __________
Study Site Name: | __________
Study Site Address: | __________
Participant Name: | __________
Participant ID Number: | __________
Principal Investigator: | __________
Telephone: | __________
Emergency Telephone (24-hour): | __________
Clearwater Institutional Review Board LLC
Address: | 3200 Bayshore Boulevard, Tampa, FL 33629
IRB Registration No.: | IRB-2019-04821
Telephone: | __________
Solstice Biomedical Inc.
Address: | 220 Westbrook Drive, Suite 400, Cambridge, MA 02142
Attention: | Marcus Hale, VP of U.S. Operations
Telephone: | __________

CONFIDENTIAL — DRAFT 1.0

INFORMED CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY

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