Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus (NCT06627517) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus
United States120 participantsStarted 2024-11-22
Plain-language summary
The purpose of this research is to evaluate the effect of a wearable insulin pump on blood sugar levels during sleep. The study device works with continuous glucose monitors (CGM) to calculate and deliver rapid-acting insulin doses during sleep. The study device does not replace long-acting, correction, or mealtime insulin. The study will involve applying the study device before bed for a period of 13 weeks. The overall study length is approximately 17 weeks.
The study aims to evaluate whether the study device is safe and if it lowers blood sugar levels in people who have consistently high blood sugar during sleep and at wake.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. ≥18 years of age at time of consent
✓. Clinical diagnosis of T1D for ≥ 6 months with a stable insulin regimen for ≥ 30 days.
✓. Using a basal-bolus regimen with multiple daily injections of insulin or doses of inhaled insulin for ≥ 3 months with a stable basal dosing regimen over the previous 30 days
✓. If using a non-insulin glucose-lowering drug, (e.g. GLP-1 agonists, SGLT2 inhibitors), must have a stable dose for ≥ 30 days
✓. If using a weight loss medication, must be on a stable dose for ≥ 30 days
✓. Using insulin lispro or insulin aspart as bolus insulin or able to obtain for the duration of the study
Exclusion criteria
✕. Use of or plan to use insulin pump therapy during the study period.
✕. Use of basal insulin for ≥ 60% of the total daily insulin dose on average over the last week per subject report.
✕. Pregnant, lactating, or plans to become pregnant in the next 17 weeks. A negative serum or urine pregnancy test is required for all females of child-bearing potential.
What they're measuring
1
Severe hypoglycemia events
Timeframe: From device activation to the end of treatment at 13 weeks
2
Diabetic ketoacidosis events
Timeframe: From device activation to the end of treatment at 13 weeks
3
Change in CGM-measured time in range (70-180 mg/dL)
Timeframe: From device activation to the end of treatment at 13 weeks
✕. Current or anticipated acute use of corticosteroids (other than topical or inhaled) or other medications that have a known effect on glycemic variability during the time period of the study
✕. Anticipated initiation of a weight loss medication and/or titration during the study period
✕. Alcohol or drug use that would reduce sensitivity to symptoms of hypoglycemia or hinder appropriate decision-making in the judgment of the investigator.