The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting. The combined run-in period and study period will be approximately 135 days long.
Phase 1 of the study, will utilize the MiniMed™ 780G Insulin pump with Guardian 4 sensor for the run-in period, study period, and optional continued access. Phase 2 of the study will utilize the MiniMed™ 780G BLE2.0 insulin pump with the Disposable Sensor 5 for the run-in period and study period which will be approximately 135 days long. A total of up to 575 subjects with at least 300 subjects entering the study period of Phase 2, with insulin-requiring diabetes age 18-80 will be enrolled at up to 40 investigational centers across the United States.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
574
MiniMed 780G insulin pump with Guardian 4 sensor (phase 1) MiniMed™ 780G BLE 2.0 insulin pump used in combination with Disposable Sensor 5 (phase 2)
Primary Safety Endpoint - Change in HbA1c Phase 1
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time frame: Baseline and end of 3-month study period
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Time frame: Last 6 weeks of 3 month study period
Primary Safety Endpoint - Change in HbA1c Phase 2 Transition
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time frame: Baseline and end of 3-month study period
Primary Safety Endpoint - Change in HbA1c Phase 2 Naive
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Time frame: Baseline and end of 3-month study period
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Time frame: Last 6 weeks of 3 month study period
Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
The mean percent of time in range (TIR 70-180 mg/dL). Superiority test.
Time frame: Last 6 weeks of 3 month study period
Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Medical Investigations
Little Rock, Arkansas, United States
Headlands Research California LLC
Escondido, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Hoag Hospital Newport Beach
Newport Beach, California, United States
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
East Coast Institute for Research
Jacksonville, Florida, United States
USF Diabetes Center
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research
Canton, Georgia, United States
...and 21 more locations
The mean percent of time in range (TIR 70-180 mg/dL). Superiority test.
Time frame: Last 6 weeks of 3 month study period