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NCT07758647

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

Sponsor: Institut de Recherches Cliniques de Montreal

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-01

Completion Date

2029-12-31

Last Updated

2026-08-11

Healthy Volunteers

Conditions

Type 1 Diabetes (T1D)

Interventions

DEVICE

Open-Source Automated Insulin Delivery (OS-AID)

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.

DEVICE

Commercial Automated Insulin Delivery (C-AID)

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 * % 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 * Current use of glucocorticoid medication (except low stable dose and inhaled steroids and stable adrenal insufficiency treatment e.g., Cortef®) * 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). * 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 * 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.

Locations (1)

Institut de Recherches Cliniques de Montréal

Montreal, Quebec, Canada