Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes (NCT06273124) | Clinical Trial Compass
CompletedNot Applicable
Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
United States260 participantsStarted 2024-03-07
Plain-language summary
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS).
Participants will be asked to:
1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age 18 to 80 years old inclusive
✓. Generally in good health, as determined by the investigator
✓. Living in the United States with no plans to move outside the United States during the study
✓. Diagnosis of T1D for at least 12 months
✓. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
✓. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
✓. Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active
✓. HbA1c \<9.0% in the last 6 months.
Exclusion criteria
✕. Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
✕. Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
✕. Episodes of severe hypoglycemia in the last 6 months resulting in:
✕. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
What they're measuring
1
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
Timeframe: 12 weeks
2
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
✕. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
✕. Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period