NO-Meal Announcement in Automated Insulin Delivery (Open-source and Commercial) Systems

Sponsor
Institut de Recherches Cliniques de Montreal
Study ID
NCT07758647
Status
Not Yet Recruiting

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Conditions

  • Type 1 Diabetes (T1D)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Open-Source Automated Insulin Delivery (OS-AID) — DEVICE
    Participants will use their own OS-AID system, including Loop, AndroidAPS, or OpenAPS, in combination with a compatible insulin pump and Dexcom G6 or Dexcom G7 continuous glucose monitoring (CGM). These systems use open-source algorithms to automatically adjust insulin delivery based on real-time CGM data through adaptive basal insulin modulation and, depending on the platform, automated correction boluses. Participants will continue using their established OS-AID settings throughout the intervention period without software updates and will be asked to perform two unannounced meal-challenges.
  • Commercial Automated Insulin Delivery (C-AID) — DEVICE
    Participants will use a commercially available hybrid closed-loop AID system compatible with Dexcom G6 or Dexcom G7 CGM. Depending on study allocation and participants' usual device, the commercial system will include Tandem t X2 with Control-IQ technology or Omnipod 5. Participants not already using a compatible commercial AID system will receive study equipment and standardized training before initiating the intervention. Commercial AID systems automatically adjust insulin delivery based on continuous glucose measurements using manufacturer-specific algorithms while continuing to recommend user-initiated meal announcements and boluses for optimal performance.

Study Details

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. 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.

Key Dates

First listed
Aug 11, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
33 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: OS-AID
    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.
  • Active Comparator: Commercial-AID
    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.

Primary Outcome Measure

Percentage of time in target glucose range during the 4 hours following unannounced meal challenges [ Time Frame: During the final 2 weeks of each 4-week intervention period (following the run-in phase). ]

Central Contacts

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