New Type 1 Study Recruiting Injection Pen Users for Overnight Patch Pump

Clinical Trials Identifier: NCT06627517

Trial Name: Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus (AID4MDI)

Diabetes Type: Type 1 diabetes

Trial Sponsor: Luna Health

What is the aim of the trial?

This virtual, at-home clinical trial will be testing the effectiveness of Luna, a new wearable insulin delivery patch to be worn during sleep. 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.

The study device is an overnight insulin patch pump with an embedded automated insulin delivery algorithm that works with continuous glucose monitors (CGMs) to calculate and deliver rapid-acting insulin doses during sleep. It is not intended to replace long-acting, correction, or mealtime insulin. Learn more about Luna here.

How does the trial work?

Approximately 130 adults with type 1 diabetes on multiple daily injections will initially wear a Dexcom G6 CGM for 28 days as well as log a sleep diary, which will be used as a baseline for the study’s primary endpoint. 

Participants will then wear an overnight patch pump with an embedded AID algorithm for a period of 13 weeks (90 days) along with a Dexcom G6, after which researchers will compare their time in range (TIR) data to participants’ initial 28-day baseline.

Researchers will be observing various outcome measures throughout the process, including severe hypoglycemic events, diabetic ketoacidosis (DKA) events, and CGM-measured changes in time in range, time above range, time below range, time in range on awakening, and fasting glucose. Change in sleep quality will be measured by the Pittsburgh Sleep Quality Index. Change in A1C will also be measured, among other measurements. The overall study length is estimated to be 17 weeks.

Are you interested in participating?

You may be eligible if you: 

• Are 18 years of age or older
• Have had a clinical diagnosis of type 1 diabetes for 6 months or longer, with a stable insulin regimen for the past 30 days or more
• Have used a basal-bolus regimen with multiple daily injections of insulin or doses of inhaled insulin for at least 3 months with a stable basal dosing regimen over the past 30 days 
• If using a non-insulin glucose-lowering drug such as GLP-1 agonists or SGLT-2 inhibitors, have been on a stable dosage for at least 30 days
• If using a weight loss medication, have been on a stable dosage for at least 30 days
• Have been using insulin lispro (Humalog) or insulin aspart (Novolog) as bolus insulin, and are able to obtain either insulin to use for the duration of the study
• Have been using the Dexcom G6 CGM for at least 3 months with at least 85% use in the prior 28 days and able to obtain obtain G6 supplies for the duration of the study
• Currently own and use an iPhone
• Experience recurrent nocturnal hyperglycemia, defined as nighttime glucose values above 180 mg/dL for 7 or more of the previous 14 days
• Have tested negative in a baseline pregnancy test and are willing to use an adequate method of birth control for the duration of the study
• Have a care partner, relative, or acquaintance nearby who is willing to be trained on the Dexcom Follow app and how to administer glucagon.
• Be willing to to share access to CGM data with the Sponsor through the Dexcom Clarity app

Those who are on insulin pump therapy, are pregnant or lactating, are on dialysis, are using hydroxyurea medication, and are initiating or titrating weight loss medication are not eligible to participate. See a complete list of inclusion and exclusion criteria here.

This study is currently actively recruiting at the Barbara Davis Center for Diabetes in Aurora, Colorado, and will soon be recruiting at additional sites nationwide; check the ClinicalTrials.gov page periodically for site updates. To enroll in this trial or learn more about it, contact Daniela Fuerte, MS at [email protected].

Read more about other the latest in insulin patch pumps:

• FDA Approves Accu-Chek Solo Tubeless Patch Pump
• Omnipod Go, a Basal-Only Insulin Pod, Cleared by the FDA
• Omnipod 5 Becomes First AID System Approved for Type 2 Diabetes