NCT06627517

Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus

Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Luna Diabetes · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes Mellitus
• Sleep Quality

Interventions

Type	Name	Description
DEVICE	Episodic overnight patch pump	Subjects will wear the study device overnight for a period of 13 weeks in conjunction with use of Dexcom G6.

Timeline

• Start date: 2024-11-22
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-10-04
• Last updated: 2025-08-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study