Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
- Conditions
- Type 1 Diabetes
- Interventions
- Device: MiniMed 780G System
- 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
- Arm && Interventions
Group Intervention Description MiniMed 780G System Utilizing Insulin Fiasp MiniMed 780G System Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Fiasp® for a period of three months.
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) 3 months Age 18-80: The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]). Non-inferiority test.
Primary Safety Endpoint for Age 18-80 - Change in HbA1c 3 months Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Safety Endpoint for Age 7-17 - Change in HbA1c 3 months Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) 3 months Age 7-17: 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 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L]) 3 months Age 18-80: The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]). Non-inferiority test.
Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) 3 months Age 7-17: The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]).Superiority test.
Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL [3.0 mmol/L]) 3 months Age 7-17: The mean % of time in hypoglycemia (\< 54 mg/dL \[3.0 mmol/L\]). Non-inferiority test.
Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]) 3 months Age 18-80: The mean % of time in range (TIR 70-180 mg/dL \[3.9 -10.0 mmol/L\]).Superiority test.
Trial Locations
- Locations (18)
Rady's Children's Hospital
🇺🇸San Diego, California, United States
Atlanta Diabetes Associates
🇺🇸Atlanta, Georgia, United States
The Docs, LLC
🇺🇸Las Vegas, Nevada, United States
Valley Research
🇺🇸Fresno, California, United States
Medical Investigations, Inc.
🇺🇸Little Rock, Arkansas, 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
Physicians East
🇺🇸Greenville, North Carolina, United States
Rainier Clinical Research Center
🇺🇸Renton, Washington, United States
MultiCare Institute for Research & Innovation
🇺🇸Tacoma, Washington, United States
John Hunter Childrens Hospital
🇦🇺New Lambton, New South Wales, Australia
Alberta Children's Hospital Research Institute
🇨🇦Calgary, Alberta, Canada
LMC Clinical Research
🇨🇦Toronto, Ontario, Canada
Diabetes and Glandular Disease Clinic, P.A.
🇺🇸San Antonio, Texas, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Barbara Davis Center for Diabetes
🇺🇸Aurora, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States