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

Medtronic Diabetes28 sites in 1 country1,500 target enrollmentMay 2025

ConditionsType 1 Diabetes Mellitus Type 2 Diabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 1 Diabetes Mellitus
Sponsor: Medtronic Diabetes
Enrollment: 1500
Locations: 28
Primary Endpoint: Primary Safety Endpoints
Status: Withdrawn
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out how well a new continuous glucose monitor works for people with diabetes. This study will test the performance of the study sensor(s) for 7-14 days of wear in patients who are 11-80 years old with type 1 or type 2 diabetes.

Registry

clinicaltrials.gov

Start Date

May 2025

End Date

December 2025

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Medtronic Diabetes

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 11-80 years at time of screening.
•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.
•Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
•Subject or parent(s)/guardian(s) is/are literate and able to read the language offered in the study materials.
•Subject and/or legally authorized representative is willing to provide informed consent for participation.
•Has adequate venous access as assessed by investigator or appropriate staff.
•Is willing to perform fingerstick blood glucose measurements as needed.
•Is willing to wear the study devices continuously throughout the study.

Exclusion Criteria

•Has a history of 1 or more episodes of severe hypoglycemia during the 6 months prior to screening visit.
•Has had a hypoglycemic seizure within the past 6 months prior to screening visit.
•Has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to enrollment.
•Has a history of allergy to dexamethasone or has been told by health care provider they may not take any products containing dexamethasone.
•Has a history of 1 or more episodes of DKA in the last 6 months prior to screening visit.
•Has a history of a seizure disorder.
•Has a central nervous system or cardiac disorder resulting in syncope.
•Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
•Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
•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).