Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT05224258
- Lead Sponsor
- Medtronic Diabetes
- Brief Summary
This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.
- Detailed Description
This global study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using Fiasp insulin as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.
A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint - Change in HbA1c 3 months The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) Last 6-7 weeks of 3-month study period The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]). Non-inferiority test.
- Secondary Outcome Measures
Name Time Method Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L]) Last 6-7 weeks of 3 month study period The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]). Non-inferiority test.
Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) Last 6-7 weeks of 3 month study period The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]).Superiority test.
Related Research Topics
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Trial Locations
- Locations (18)
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, United States
Valley Research
🇺🇸Fresno, California, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Rady's Children's Hospital
🇺🇸San Diego, California, United States
Barbara Davis Center for Diabetes
🇺🇸Aurora, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
Endocrine Research Solutions
🇺🇸Roswell, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Barry J Reiner MD, LLC
🇺🇸Baltimore, Maryland, United States
Scroll for more (8 remaining)Medical Investigations, Inc.🇺🇸Little Rock, Arkansas, United States