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Type 1 Diabetes MellitusAID4MDINCT06627517

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

A study testing Episodic overnight patch pump in people with Type 1 Diabetes Mellitus and Sleep Quality, run by Luna Diabetes at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus, Sleep Quality
What is being tested?
Episodic overnight patch pump
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesUnited States
Study dates
22 Nov 2024to Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Use of or plan to use insulin pump therapy during the study period.
  • Use of basal insulin for ≥ 60% of the total daily insulin dose on average over the last week per subject report.
  • 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.
  • Known stage 4/5 renal failure or on dialysis
  • Using Hydroxyurea medication
  • 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
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  • Anticipated initiation of a weight loss medication and/or titration during the study period
  • Alcohol or drug use that would reduce sensitivity to symptoms of hypoglycemia or hinder appropriate decision-making in the judgment of the investigator.
  • Use of electrically powered implant(s) that may be susceptible to RF interference, such as cardiac pacemakers, spinal cord stimulators, or implantable cardioverter-defibrillators.
  • Severe hypoglycemia (defined as requiring 3rd party assistance and/or loss of consciousness or seizure) within 90 days prior to screening.
  • Diabetic ketoacidosis (DKA) diagnosed at a health care facility within 90 days prior to screening
  • Use of an investigational drug in the 30 days prior to screening.
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: Automated Insulin Delivery for Multiple Daily Injectors (AID4MDI)

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.

Being tested
Episodic overnight patch pump
Keywords
overnight hyperglycemia, sleep quality, type 1 diabetes, closed loop
Medical subject headings
Diabetes Mellitus, Type 1, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Episodic overnight patch pumpDevice

    Subjects will wear the study device overnight for a period of 13 weeks in conjunction with use of Dexcom G6.

Study groups in NCT06627517
Study groupRoleWhat they receive
Overnight wear of study deviceExperimentalSubjects will wear the study device during sleep in addition to their usual basal/bolus therapy.
Receives: Device: Episodic overnight patch pump

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe hypoglycemia events

    Measured: From device activation to the end of treatment at 13 weeks

  2. Diabetic ketoacidosis events

    Measured: From device activation to the end of treatment at 13 weeks

  3. Change in CGM-measured time in range (70-180 mg/dL)

    Measured: From device activation to the end of treatment at 13 weeks

Secondary outcomes (10)

  1. Change in CGM-measured percentage of time > 180 mg/dL

    Measured: From device activation to the end of treatment at 13 weeks

  2. Change in CGM-measured percentage of time > 250 mg/dL

    Measured: From device activation to the end of treatment at 13 weeks

  3. Change in CGM-measured percentage of time waking in range (70-180 mg/dL)

    Measured: From device activation to the end of treatment at 13 weeks

  4. Change in CGM-measured fasting glucose at the end of the sleep period

    Measured: From device activation to the end of treatment at 13 weeks

  5. Change in Pittsburgh Sleep Quality Index (PSQI) score

    Scale of 0 to 21 with higher scores being a worse outcome

    Measured: From device activation to the end of treatment at 13 weeks

  6. Change in HbA1c

    Measured: From device activation to the end of treatment at 13 weeks

  7. Change in Epworth Sleepiness Scale (ESS) score

    Scale of 0 to 24 with higher scores being a worse outcome

    Measured: From device activation to the end of treatment at 13 weeks

  8. Rate, severity, and device-relatedness of all adverse events

    Measured: From device activation to the end of treatment at 13 weeks

  9. Change in CGM-measured time < 70 mg/dL

    Measured: From device activation to the end of treatment at 13 weeks

  10. Change in CGM-measured time < 54 mg/dL

    Measured: From device activation to the end of treatment at 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2024
  2. Study start22 Nov 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06627517
Sponsor's protocol ID
LH2024-01
Acronym
AID4MDI
Status last verified
Dec 2024
First submitted
2 Oct 2024
Last updated
27 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Episodic overnight patch pump in people with Type 1 Diabetes Mellitus and Sleep Quality, run by Luna Diabetes at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe hypoglycemia events (time frame: From device activation to the end of treatment at 13 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06627517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2025.

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