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Insulin Delivery Device

Luna System for Diabetes (AID4MDI Trial)

N/A
Recruiting
Led By Jeremy H Pettus, MD
Research Sponsored by Luna Diabetes
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. ≥18 years of age at time of consent
6. Using insulin lispro or insulin aspart as bolus insulin or able to obtain for the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from device activation to the end of treatment at 13 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to test a wearable insulin pump that works with continuous glucose monitors to deliver quick insulin doses during sleep. The study will last for 17 weeks, with participants using the device before bed for

Who is the study for?
This trial is for adults over 18 with Type 1 Diabetes who've been on a stable insulin regimen for at least a month. They must use rapid-acting insulin, have used CGM systems for three months or more, and experience high blood sugar at night frequently. Participants need to be iPhone users and cannot start new glucose-lowering or weight loss drugs within the last month.
What is being tested?
The study tests an overnight patch pump that works with continuous glucose monitors to manage blood sugar levels during sleep. It's not meant to replace other insulins but aims to stabilize nighttime blood sugars over a 13-week period of use before bedtime.
What are the potential side effects?
While specific side effects are not listed, typical risks may include skin irritation from the patch, low blood sugar episodes (hypoglycemia), or potential inaccuracies in insulin dosing leading to altered blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I use insulin lispro or aspart, or I can get it for the study.
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My nighttime blood sugar was over 180 mg/dL on most nights in the last 2 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from device activation to the end of treatment at 13 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from device activation to the end of treatment at 13 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change in Epworth Sleepiness Scale (ESS) score
Change in Pittsburgh Sleep Quality Index (PSQI) score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Overnight wear of study deviceExperimental Treatment1 Intervention
Subjects will wear the study device during sleep in addition to their usual basal/bolus therapy.

Find a Location

Who is running the clinical trial?

Luna DiabetesLead Sponsor
Jeremy H Pettus, MDPrincipal InvestigatorUniversity of California, San Diego
~87 spots leftby May 2025
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