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

No results posted yet for this study

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07212179 on ClinicalTrials.gov