Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus (NCT06627517)
Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Diablo Clinical Research — Walnut Creek, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- Diablo Clinical Research — Walnut Creek, California
- Barbara Davis Center for Diabetes — Aurora, Colorado
- International Diabetes Center — Minneapolis, Minnesota
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes Mellitus
- Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) — Chicago, Illinois
- Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes — Orange, California
- A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation — Chicago, Illinois
- Triple Therapy in T1DM — Williamsville, New York
- Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) — Toronto, British Columbia
Explore by condition: All Type 1 Diabetes Mellitus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.