Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery
Anas El Fathi
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.
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). Part…
Eligibility
- Age range
- 14–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Age ≥14.0 and ≤21 years old at time of consent 2. HbA1c ≤ 10%. 3. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 4. Having used an insulin pump within the last three months. 5. Currently using insulin for at least six months 6. 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 7. Willingness to switch to a commercially approved insulin (e.g. lispro or aspart or biosimilar approved products) within the study pu…
Interventions
- DeviceAID + InsuLearn-SMA
Automated insulin delivery (AID) system with InsuLearn simplified meal announcement bolus calculator
- DeviceAID + CC
Automated insulin delivery (AID) system using usual carbohydrate counting bolus calculator
Location
- University of Virginia Center for Diabetes TechnologyCharlottesville, Virginia