NCT07212179

Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Anas El Fathi · Academic / Other
• Sex: All
• Age: 14 Years – 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Following recruitment and screening, participants will be randomized to one of two sequences during the Hotel Admission: AID+InsuLearn-SMA→AID+CC or AID+CC→AID+InsuLearn-SMA. All participants will be trained on the study equipment, which includes (i) the DiAs smartphone running the Control-IQ algorithm with either the InsuLearn-SMA bolus calculator or the standard carbohydrate counting bolus calculator, and (ii) the Dexcom CGM. All participants will complete 7 days/6 nights run-in At-Home Period using the AID+CC system (Control-IQ with the standard carbohydrate counting bolus calculator). Participants will then undergo a 2-night supervised hotel admission (approximately 48 hours). During this admission, each participant will consume two standardized meals (dinner and breakfast), during which either the InsuLearn-SMA bolus calculator or the standard CC bolus calculator will be used in a randomized order. Two lunches will be offered during the Hotel Admission but not included in the analysis. Following discharge, all participants will complete 7 days/6 nights At-Home Period using the AID+InsuLearn-SMA system before returning the study equipment. The INSPIRE Questionnaire will be administered before and after the Hotel Admission. Additionally, participants will be asked to provide a 2-week CGM data download of their usual care for statistical analysis before randomization and after returning the equipment.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-03-03
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2025-10-08
• Last updated: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study