In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System i… (NCT05238142) | Clinical Trial Compass
CompletedNot Applicable
In-Home Study With MiniMedâ„¢ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes
United States574 participantsStarted 2022-02-25
Plain-language summary
The objective of the study is to assess the safety and effectiveness of MiniMedâ„¢ 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Is age 18 - 80 years at time of screening.
✓. Has a clinical diagnosis of type 2 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
✓. Is on MDI regimen (basal/bolus regimen with long-acting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months prior signing the informed consent, or CSII pump therapy with or without CGM. The investigator will use their discretion to verify that insulin requirements have been stable for the last 3 months prior to screening.
✓. Is able to comply with technology, according to Investigator's judgment
✓. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
✓. Is willing to perform fingerstick blood glucose measurements as needed.
✓. Is willing to wear the system continuously throughout the study.
✓. Has a Glycosylated hemoglobin (HbA1c) of less than 10% (as processed by Central Lab) at time of screening visit.
Exclusion criteria
✕. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
✕. Medical assistance (i.e., Paramedics, Emergency Room \[ER\] or Hospitalization)
What they're measuring
1
Primary Safety Endpoint - Change in HbA1c Phase 1
Timeframe: Baseline and end of 3-month study period
2
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
Timeframe: Last 6 weeks of 3 month study period
3
Primary Safety Endpoint - Change in HbA1c Phase 2 Transition
Timeframe: Baseline and end of 3-month study period
4
Primary Safety Endpoint - Change in HbA1c Phase 2 Naive
Timeframe: Baseline and end of 3-month study period
5
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
✕. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
✕. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
✕. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
✕. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at time of screening.