Contract analysis

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

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 It is designed to be worn continuously for up to fourteen (14) days (appr

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 fol

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 R

5. POTENTIAL BENEFITS 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 awar

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 met

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 nu

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

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 eme

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 o

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 y

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 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 c

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, swel

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 gi