Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in A… (NCT07212179) | Clinical Trial Compass
CompletedNot Applicable
Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
United States2 participantsStarted 2026-03-03
Plain-language summary
To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.
Who can participate
Age range14 Years – 21 Years
SexALL
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Inclusion criteria
✓. Age ≥14.0 and ≤21 years old at time of consent
✓. HbA1c ≤ 10%.
✓. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year
✓. Having used an insulin pump within the last three months.
✓. Currently using insulin for at least six months
✓. Willingness to use insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections
✓. Willingness to switch to a commercially approved insulin (e.g. lispro or aspart or biosimilar approved products) within the study pump as directed by the study team.
✓. Has one or more supportive caregivers or companions living with the participant who are knowledgeable about emergency procedures for treatment of severe hypoglycemia and able to contact emergency services and study staff.
Exclusion criteria
✕. History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
✕. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment
✕. Pregnancy or intent to become pregnant during the trial
✕. Currently breastfeeding or planning to breastfeed