SYNERGY PLUS: Evaluation of Next Generation Sensors (NGS) and Algorithm in Patients With Type 1 and Type 2 Diabetes

Launched by MEDTRONIC DIABETES · Dec 2, 2024

Keywords

ClinConnect Summary

The SYNERGY PLUS trial is looking to evaluate a new type of continuous glucose monitor (CGM) designed for people with diabetes. This trial aims to see how well this device works over a period of 7 to 14 days for individuals aged 11 to 80 who have either type 1 or type 2 diabetes. If you're interested in participating, you'll need to have been diagnosed with diabetes for at least six months and be able to provide informed consent. You'll also need to be comfortable performing fingerstick blood tests during the study and wearing the monitoring device continuously.

Before joining, there are some health conditions that may exclude you from the trial, such as a history of severe low blood sugar episodes or certain heart-related issues. The trial is not yet recruiting participants, but if you meet the eligibility criteria, it could be an opportunity to help researchers understand how this new technology can improve diabetes management. This study not only aims to benefit participants but also hopes to provide valuable insights for future diabetes care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 11-80 years at time of screening.
• • 2. Has a clinical diagnosis of type 1 or type 2 diabetes for 6 months or more, as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• • 3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
• • 4. Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials.
• • 5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
• • 6. Has adequate venous access as assessed by investigator or appropriate staff.
• • 7. Is willing to perform fingerstick blood glucose measurements as needed.
• • 8. Is willing to wear the study devices continuously throughout the study.
• Exclusion Criteria:
• • 1. Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
• • 2. Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
• • 3. Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
• • 4. Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
• • 5. Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
• • 6. Has a history of a seizure disorder.
• • 7. Has a central nervous system or cardiac disorder resulting in syncope.
• • 8. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• • 9. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• • 10. Is pregnant or lactating, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD or implant).
• • 11. Has diagnosis of adrenal insufficiency.
• • 12. Is using hydroxyurea at time of screening or plans to use it during the study.
• • 13. Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. (Please note participation in an observational study is acceptable.)
• • 14. Has a planned procedure involving the use of a Magnetic Resonance Imaging (MRI), diathermy devices, or other devices that generate strong magnetic fields (e.g., x-ray, CT scan, or other types of radiation) during the study wear period.
• • 15. Has elective surgery or hospitalization planned during the course of the study.
• • 16. Has a clinical diagnosis of type 1 and is using pramlintide (Symlin), DPP-4 inhibitor, GLP-1 receptor agonist, metformin, and/or SGLT2 inhibitor at time of screening.
• • 17. Is currently abusing illicit drug(s).
• • 18. Is currently abusing marijuana.
• • 19. Is currently abusing prescription medication(s).
• • 20. Is currently abusing alcohol.
• • 21. Has a hematocrit (Hct) more than 10% below the lower limit of normal reference range (please note that patients may use prior blood draw from routine care as long as done within 6 months of screening and report of lab placed with subject source documents).
• • 22. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
• • 23. Has had any of the following cardiovascular events 1 year or more prior to screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. Subject may be enrolled if clearance from a cardiologist is provided prior to or at screening.
• • 24. Has any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
• • 25. Is a member of the research staff involved with the study.
• • 26. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).