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

Not Applicable

Recruiting

• Conditions: Type 1 Diabetes Mellitus; Sleep Quality
• Interventions: Device: Episodic overnight patch pump

• Registration Number: NCT06627517
• Lead Sponsor: Luna Diabetes

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Study First Submitted QC: 2024-10-02
• Study First Posted: 2024-10-04
• Study Start: 2024-11-22
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-21
• Primary Completion: 2025-05
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Overnight wear of study device	Episodic overnight patch pump	Subjects will wear the study device during sleep in addition to their usual basal/bolus therapy.

Primary Outcome Measures

Name	Time	Method
Severe hypoglycemia events	From device activation to the end of treatment at 13 weeks
Diabetic ketoacidosis events	From device activation to the end of treatment at 13 weeks
Change in CGM-measured time in range (70-180 mg/dL)	From device activation to the end of treatment at 13 weeks

Secondary Outcome Measures

Name	Time	Method
Change in CGM-measured percentage of time > 180 mg/dL	From device activation to the end of treatment at 13 weeks
Change in CGM-measured percentage of time > 250 mg/dL	From device activation to the end of treatment at 13 weeks
Change in CGM-measured percentage of time waking in range (70-180 mg/dL)	From device activation to the end of treatment at 13 weeks
Change in CGM-measured fasting glucose at the end of the sleep period	From device activation to the end of treatment at 13 weeks
Change in Pittsburgh Sleep Quality Index (PSQI) score	From device activation to the end of treatment at 13 weeks	Scale of 0 to 21 with higher scores being a worse outcome
Change in HbA1c	From device activation to the end of treatment at 13 weeks
Change in Epworth Sleepiness Scale (ESS) score	From device activation to the end of treatment at 13 weeks	Scale of 0 to 24 with higher scores being a worse outcome
Rate, severity, and device-relatedness of all adverse events	From device activation to the end of treatment at 13 weeks
Change in CGM-measured time < 70 mg/dL	From device activation to the end of treatment at 13 weeks
Change in CGM-measured time < 54 mg/dL	From device activation to the end of treatment at 13 weeks

Trial Locations

Locations (3)

Diablo Clinical Research; 🇺🇸 Walnut Creek, California, United States

International Diabetes Center; 🇺🇸 Minneapolis, Minnesota, United States

Barbara Davis Center for Diabetes; 🇺🇸 Aurora, Colorado, United States