Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
NCT07212179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2026-05-11
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.
Conditions
Interventions
- DEVICE
-
AID + InsuLearn-SMA
Automated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator
- DEVICE
-
AID + CC
Automated insulin delivery (AID) system using usual carbohydrate counting bolus calculator
Sponsors & Collaborators
-
Melissa J. Schoelwer
lead OTHER
Principal Investigators
-
Melissa Schoelwer, MD · University of Virginia School of Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 14 Years
- Max Age
- 21 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-03
- Primary Completion
- 2026-04-14
- Completion
- 2026-04-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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