Evaluating a wearable insulin pump for managing blood sugar during sleep in type 1 diabetes

Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)

This study is testing a new wearable insulin pump to see if it can help people with type 1 diabetes manage their blood sugar levels better while they sleep.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Luna Diabetes (Industry-sponsored)
• Locations: 3 sites (Walnut Creek, California and 2 other locations)
• Trial ID: NCT06627517 on ClinicalTrials.gov

What this trial studies

This research evaluates the safety and effectiveness of a wearable insulin pump designed to manage blood sugar levels during sleep in individuals with type 1 diabetes. The device works in conjunction with continuous glucose monitors to deliver rapid-acting insulin doses overnight. Participants will use the device for 13 weeks while monitoring their blood sugar levels, with the overall study lasting approximately 17 weeks. The goal is to determine if the device can effectively lower blood sugar levels in patients who experience high blood sugar during sleep.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a clinical diagnosis of type 1 diabetes for at least six months and a stable insulin regimen.

Not a fit: Patients who do not use continuous glucose monitors or have unstable insulin regimens may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve overnight blood sugar control and overall sleep quality for patients with type 1 diabetes.

How similar studies have performed: Other studies have shown promise in using closed-loop systems for diabetes management, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria

1. ≥18 years of age at time of consent
2. Clinical diagnosis of T1D for ≥ 6 months with a stable insulin regimen for ≥ 30 days.
3. Using a basal-bolus regimen with multiple daily injections of insulin or doses of inhaled insulin for ≥ 3 months with a stable basal dosing regimen over the previous 30 days
4. If using a non-insulin glucose-lowering drug, (e.g. GLP-1 agonists, SGLT2 inhibitors), must have a stable dose for ≥ 30 days
5. If using a weight loss medication, must be on a stable dose for ≥ 30 days
6. Using insulin lispro or insulin aspart as bolus insulin or able to obtain for the duration of the study

5. If using a weight loss medication, must be on a stable dose for ≥ 30 days 6. Using insulin lispro or insulin aspart as bolus insulin or able to obtain for the duration of the study 7. Using CGM (real-time or intermittent scanning) for ≥ 3 months (with at least 50% use), and at least 85% use in the prior 14 days 8. Using Dexcom G6 or able to obtain for the duration of the study 9. Using an iPhone as part of daily life or able to obtain for the duration of the study 10. Recurrent nocturnal hyperglycemia, defined as ≥ 7 of the previous 14 days with a nighttime glucose value \> 180 mg/dL.

* Nighttime is defined at the discretion of the investigator and is intended to be the time period from when the subject goes to bed to when they get up in the morning 11. Negative baseline pregnancy test. Females of childbearing potential, willing to use an adequate method of birth control for the duration of the study.
* Adequate methods of birth control include hormonal contraceptives, intrauterine devices, or double barrier contraception, e.g., condom + diaphragm, condom or diaphragm + spermicidal gel, or foam.
* Menopause is defined as one year without menses; if in question, a follicle stimulating hormone of \>40 U/ml must be documented.
* Hysterectomy, bilateral oophorectomy, or bilateral tubal ligation must be documented as applicable.

  12. Availability of a relative or acquaintance residing within 15 minutes of the subject and willing to be the subject's care partner throughout the study.
* The care partner must be willing to be trained on how to use the Dexcom Follow app and administer glucagon.
* The care partner must be willing to contact the subject upon a low or high alarm, provide aid to the subject, including glucagon administration, and/or contact emergency services.

  13. Willing to share access to CGM data with the Sponsor through the Dexcom Clarity app 14. No medical, psychiatric, or other conditions, or medications being taken that in the Investigator's judgement would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.

Exclusion Criteria

1. Use of or plan to use insulin pump therapy during the study period.
2. Use of basal insulin for ≥ 60% of the total daily insulin dose on average over the last week per subject report.
3. Pregnant, lactating, or plans to become pregnant in the next 17 weeks. A negative serum or urine pregnancy test is required for all females of child-bearing potential.
4. Known stage 4/5 renal failure or on dialysis
5. Using Hydroxyurea medication
6. Current or anticipated acute use of corticosteroids (other than topical or inhaled) or other medications that have a known effect on glycemic variability during the time period of the study
7. Anticipated initiation of a weight loss medication and/or titration during the study period
8. Alcohol or drug use that would reduce sensitivity to symptoms of hypoglycemia or hinder appropriate decision-making in the judgment of the investigator.
9. Use of electrically powered implant(s) that may be susceptible to RF interference, such as cardiac pacemakers, spinal cord stimulators, or implantable cardioverter-defibrillators.
10. Severe hypoglycemia (defined as requiring 3rd party assistance and/or loss of consciousness or seizure) within 90 days prior to screening.
11. Diabetic ketoacidosis (DKA) diagnosed at a health care facility within 90 days prior to screening
12. Use of an investigational drug in the 30 days prior to screening.
13. Employed by or has immediate family members employed by Luna Health; is directly involved in conducting the clinical study; has a direct supervisor at the place of employment who is also directly involved in conducting the clinical study (as a study investigator, coordinator, etc.); or has a first-degree relative who is directly involved in conducting the clinical study.

Where this trial is running

Walnut Creek, California and 2 other locations

• Diablo Clinical Research — Walnut Creek, California, United States (Recruiting)
• Barbara Davis Center for Diabetes — Aurora, Colorado, United States (Recruiting)
• International Diabetes Center — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Jeremy H Pettus, MD — University of California, San Diego
• Study coordinator: Daniela Fuerte, M.S.

Conditions Type 1 Diabetes Mellitus; Sleep Quality; overnight hyperglycemia; sleep quality; type 1 diabetes; closed loop