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Comparing open-source and commercial automated insulin systems when meals are not announced

Compares two automated insulin systems after unannounced meals in adults with type 1 diabetes.

Key facts

Who runs it
Institut de Recherches Cliniques de Montreal
Where
Montreal, CanadaSee the site
Trial code
Registry title
NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems
Status
Not yet recruiting
People taking part
33 people, planned
Started
1 Oct 2026
Expected to end
31 Dec 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Open-Source Automated Insulin Delivery (OS-AID)
  • Commercial Automated Insulin Delivery (C-AID)
Record updated
11 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with type 1 diabetes in Canada or the USA who already use an open-source automated insulin delivery system with a Dexcom G6 or G7 sensor.

Age
18 years or older
Sex
Men and women
Disease stage
Type 1 diabetes for at least one year
Earlier treatment
Must have used open-source automated insulin delivery (OS-AID) for at least 2 weeks. Must be willing to switch from ultra-rapid insulin to rapid-acting insulin.

Main reasons for not taking part

  • Using regular insulin or U200 or U500 concentrated insulin
  • Pregnancy, trying to become pregnant, or breastfeeding
  • Severe low blood sugar within one month, or severe high blood sugar needing hospital care in the last 3 months
  • Serious kidney, nerve or eye disease judged by the investigator, or a heart event in the last 3 months
  • Planned trip abroad during the study

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • Males and females ≥ 18 years old currently residing in Canada or the United States of America (USA)
  • Having a clinical diagnosis of T1D for at least one year (based on the investigator's judgment; C peptide level and antibody determinations are not needed.)
  • Having been on OS-AID therapy for at least 2 weeks and using a Dexcom G6 or G7 CGM
  • If using an ultra-rapid acting insulin, be willing to switch to a rapid-acting insulin, as the former are not recommended in the C-AID systems used in the study (due to the risk of cannula or pod blockage)
  • Accepting that personal pump setting parameters will be collected by the research team. This access will be limited to the study period

Who cannot take part

  • Anticipated therapeutic change (including change of CGM sensor [other than Dexcom sensors] or AID system type, new antidiabetic drug initiation) between admission and end of the study
  • Current use of SGLT-2 inhibitors or GLP1 agonists or other antidiabetic agents (Metformin, DPP-4 inhibitors) unless at a stable dose for at least 3 months, without anticipated change during the study and appropriate ketone testing is performed (for iSGLT2 treatment)
  • Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
  • Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®)
  • Known or suspected allergies to study products (e.g., Dexcom adhesive)
  • Other serious medical illnesses likely to interfere with study participation or with the ability to complete the study by the judgment of the investigator
  • Participant-reported clinically significant nephropathy (eGFR < 25 ml/min/1.73m2, planned or on dialysis), neuropathy (e.g., known uncontrolled gastroparesis) or retinopathy (e.g., proliferative retinopathy with ongoing active treatment such as laser photocoagulation or planned surgery) as judged by the investigator
  • Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
  • % of time spent out of automated mode exceeding 10% in last month's trial start
  • Anticipated need to use hydroxyurea during the study period (as it can interfere with CGM readings)
  • Pregnancy (ongoing or current attempt to become pregnant)
  • Breastfeeding
  • Plan to go abroad in a foreign country during the study period
  • Severe hypoglycemic episode within one month of screening
  • Severe hyperglycemic episode (including DKA) requiring hospitalization in the last 3 months
  • Anticipation of a significant change in exercise or diet regimen between admission and end of the study (i.e., starting or stopping an organized sport; planned significant diet change)
  • Anticipated radiologic examination at the time of study assessment incompatible with CGM wear (e.g., MRI)
  • In the opinion of the investigator, a participant who is unable or unwilling to observe the contraindications of the study device

Where in Canada

  • Institut de Recherches Cliniques de MontrealMontreal, CanadaContact: Joséphine Molveau, PhDNo longer taking part

About the trial

What the trial wants to find out

Automated insulin delivery (AID) systems are the current gold standard for the management of type 1 diabetes (T1D), improving glycemic control, reducing hypoglycemia, and decreasing treatment burden. Although both commercial AID (C-AID) and open-source AID (OS-AID) systems have demonstrated significant clinical benefits, direct randomized comparisons between these systems remain scarce. Moreover, an important limitation of currently available AID systems is their reliance on user-initiated meal announcements and carbohydrate counting, which remain major contributors to postprandial dysglycemia and treatment burden. While emerging evidence suggests that AID systems may partially compensate for missed meal announcements, their comparative performance under these challenging real-world conditions is unknown.

Read full original descriptionShow less

The NOMAD study is an international, multicenter, open-label, randomized, non-inferiority crossover trial designed to compare an open-source AID system with commercially available AID systems (including Tandem Control-IQ and Omnipod 5) in adults with type 1 diabetes currently using an open-source AID system. The study specifically evaluates glycemic outcomes following standardized unannounced meal challenges performed under free-living conditions.

A total of 33 participants will be enrolled and complete two 4-week intervention periods, each consisting of a 2-week run-in phase followed by a 2-week data collection phase, with crossover between treatment arms. Participants will continue using their own Dexcom G6 or Dexcom G7 continuous glucose monitoring system throughout the study.

The primary outcome is the percentage of time spent in the target glucose range (3.9-10.0 mmol/L) during the 4 hours following standardized unannounced meal challenges. Secondary outcomes include additional CGM metrics (time above and below range, glucose variability, mean glucose, and GMI), insulin delivery characteristics, and patient-reported outcomes evaluating treatment satisfaction, usability, and diabetes-related burden.

The 2 groups in the trial

  • OS-AIDExisting treatment, for comparison

    Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, together with their usual compatible insulin pump and a Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM) system. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period.

    Treatment: Open-Source Automated Insulin Delivery (OS-AID)

  • Commercial-AIDExisting treatment, for comparison

    Participants will use a C-AID system compatible with Dexcom CGM, including Tandem t X2 with Control-IQ or Omnipod 5, depending on their device and study allocation. Participants will receive study-provided equipment and training. During the data collection phase, participants will complete two standardized unannounced meal challenges under free-living conditions. CGM and insulin pump data will be collected throughout the intervention period.

    Treatment: Commercial Automated Insulin Delivery (C-AID)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems
Plain-language title
Comparing open-source and commercial automated insulin systems when meals are not announcedGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Record updated
11 August 2026