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

NCT06627517 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-08-27

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Luna Diabetes

    lead INDUSTRY

Principal Investigators

  • Jeremy H Pettus, MD · University of California, San Diego

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-22
Primary Completion
2025-09-30
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06627517 on ClinicalTrials.gov