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.
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).
Using regular insulin (Novolin ge Toronto or Humulin R) or U200 or U500 concentrated insulin (e.g. Humalog U200, Entuzity U500)
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
Recent (<3 months) acute macrovascular event (e.g., acute coronary syndrome or cardiac surgery)
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
Crossover
Open-Source Automated Insulin Delivery (OS-AID)
DeviceParticipants 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)
DeviceParticipants 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.
Percentage of time in target glucose range during the 4 hours following unannounced meal challenges
Percentage of time with sensor glucose between 3.9 and 10.0 mmol/L (70-180 mg/dL) during the 4 hours following standardized unannounced meal challenges, measured using continuous glucose monitoring (CGM). Data will be analyzed at the meal level using all meal challenges completed during each intervention period.
Time in tight range
Percentage of time with sensor glucose between 3.9 and 7.8 mmol/L (70-140 mg/dL), measured by CGM.
Time Above Range (>10 mmol/L)
Percentage of time with sensor glucose \>10.0 mmol/L (\>180 mg/dL), measured by CGM.
Time Above Range (>13.9 mmol/L)
Percentage of time with sensor glucose \>13.9 mmol/L (\>250 mg/dL), measured by CGM.
Mean Glucose
Mean sensor glucose concentration (mmol/L) measured using CGM.
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Institut de Recherches Cliniques de Montreal
Lead sponsor
Stanford University
Collaborator
University of Alberta
Collaborator
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