Evaluation of MiniMed next-generation extended-wear sensors (DS5K / Unity) and algorithm in T1D and T2D
What this study tests
A multi-site US clinical study evaluating the safety and performance of Medtronic MiniMed's next-generation disposable extended-wear CGM sensors (MMT-5600XNG and MMT-5600X, labeled DS5K / Unity) and algorithm over up to approximately 46 days in children and adults with T1D or T2D.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-10-07.
Most recent recorded citation date: 2026-10-07. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Individuals aged 2–80 years with a clinical diagnosis of type 1 or type 2 diabetes. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 19 October 2026 (ClinicalTrials.gov first posted and last updated 7 October 2026): recruiting in the United States; estimated n=1500; estimated primary and study completion December 2027.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Primary safety endpoints (device-related adverse events) up to approximately 46 days
The full picture
What the study asks
NCT07864168 is a large US clinical evaluation of Medtronic MiniMed's next-generation disposable extended-wear continuous glucose monitoring (CGM) sensors (MMT-5600XNG and MMT-5600X, labeled DS5K and referred to as Unity) and associated algorithm in people with type 1 or type 2 diabetes.1
Who it involves
Children and adults aged 2–80 years with a clinical diagnosis of type 1 or type 2 diabetes across US clinical sites.1
Design and timing
The registry lists an estimated enrollment of 1,500 participants, an estimated start in October 2026, and estimated primary and study completion in December 2027. The primary outcome tracks device-related adverse events over a study window of up to approximately 46 days.1
Evidence and limits
No results are posted. Because the trial enrolls both type 1 and type 2 diabetes participants, any future pooled accuracy or safety readout will need to be separated by diabetes type and age group before scoring type 1 performance.1
Sources
- [1]Evaluation of the Next Generation Extended Wear Sensors and Algorithm in Subjects With Type 1 and Type 2 Diabetes (NCT07864168) · Trial registry · 2026-10-07 — Protocol and current registry status checked 19 October 2026: RECRUITING; estimated n=1500; first posted 7 October 2026; no results posted.
ClinicalTrials.gov. NCT07864168. Record checked 19 October 2026; first posted and last updated 2026-10-07.