Evaluation of MiniMed Next Generation Extended Wear Sensors and Algorithm in Patients With Type 1 and Type 2 Diabetes
Part of paid clinical trials in Chula Vista, California.
- Sponsor
- Medtronic MiniMed, Inc.
- Study ID
- NCT07864168
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 2 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Next Generation Extended Wear Sensors — DEVICEDisposable Sensor (MMT-5600XNG and MMT-5600X) - labeled as DS5K and referred to as Unity
Study Details
This study will collect sensor data in subjects with T1D or T2D, 2-80 years of age.
Key Dates
- First listed
- Oct 7, 2026
- Start date
- Oct 31, 2026
- Status verified
- Oct 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 1,500 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- OTHER
Arms
- Experimental: Next Generation Extended Wear SensorsAll subjects will wear the sensor. Each subject and subject's parent/guardian/caregiver (if applicable) may insert and tape (if applicable) the study glucose sensors once trained or have them inserted and taped (if applicable) by the trained investigational center staff.
Primary Outcome Measure
Primary Safety Endpoints [ Time Frame: Approximately up to 46 days ]
Central Contacts
- Robin Mottackel818-576-4886
Locations (18)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| ProSciento | Chula Vista | California | 91911 | Gloria Keopuhiwa Elaine Watkins (PRINCIPAL_INVESTIGATOR) |
| Stanford University | Palo Alto | California | 94304 | Rayhan Lal (PRINCIPAL_INVESTIGATOR) |
| Rady Children's Hospital - San Diego | San Diego | California | 92123 | Anna Cymbaluk (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes | San Francisco | California | 94158 | Laya Ekhlaspour (PRINCIPAL_INVESTIGATOR) |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | Alexis Marquardt Andrew Rhinehart (PRINCIPAL_INVESTIGATOR) |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | Mark Christiansen (PRINCIPAL_INVESTIGATOR) |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | Satish Garg (PRINCIPAL_INVESTIGATOR) |
| Barbara Davis Center for Diabetes | Aurora | Colorado | 80045 | Lindsey Towers Gregory Forlenza (PRINCIPAL_INVESTIGATOR) |
| Yale University School of Medicine | New Haven | Connecticut | 06511 | Marcia DeSousa Laura Nally (PRINCIPAL_INVESTIGATOR) |
| University of Florida | Gainesville | Florida | 32610 | Michael Haller (PRINCIPAL_INVESTIGATOR) |
| University of South Florida (USF) Diabetes and Endocrinology Center | Tampa | Florida | 33612 | Dorothy Shulman (PRINCIPAL_INVESTIGATOR) |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | Research Admin Bruce Bode (PRINCIPAL_INVESTIGATOR) |
| Rocky Mountain Clinical Research | Idaho Falls | Idaho | 83404 | Isabella Wenstrom David Liljenquist (PRINCIPAL_INVESTIGATOR) |
| Texas Diabetes and Endocrinology | Austin | Texas | 78749 | Lindsay Harrison (PRINCIPAL_INVESTIGATOR) |
| Diabetes and Glandular Disease Clinic | San Antonio | Texas | 78229 | Mark Kipnes (PRINCIPAL_INVESTIGATOR) |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | Emma Emory Mark DeBoer (PRINCIPAL_INVESTIGATOR) |
| Rainier Clinical Research Center | Renton | Washington | 98057 | Sheryl Marks (PRINCIPAL_INVESTIGATOR) |
| Seattle Children's | Seattle | Washington | 98105 | Catherine Pihoker (PRINCIPAL_INVESTIGATOR) |
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ProSciento· Chula Vista, CAStanford University· Palo Alto, CARady Children's Hospital - San Diego· San Diego, CAUniversity of California San Francisco UCSF The Madison Clinic for Pediatric Diabetes· San Francisco, CASansum Diabetes Research Institute· Santa Barbara, CADiablo Clinical Research, Inc.· Walnut Creek, CA
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