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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. Known stage 4/5 renal failure or on dialysis
. Using Hydroxyurea medication
. 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.