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InsuLearn Feasibility With Type 1 Diabetes Patients Under MDI Therapy

NCT06411548 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-05-14

No results posted yet for this study

Summary

This is a 24-hour, randomized, crossover, single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care (UC) intervention. In the InsuLearn intervention, insulin doses are optimized using data collected in a 4-weeks at home data collection period.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

InsuLearn

InsuLearn is an artificial intelligence (AI)-algorithm that analyses collected participants data: CGM, insulin, and meal categories to learn the optimal insulin dose. InsuLearn will run offline in a study laptop to generate the optimal insulin dose for each meal category. The algorithm will generate an ambulatory glucose profile (AGP) report with new settings for the InPen™ meal estimation bolus calculator. The study physician will review the report and the algorithm recommendations. The study physician can accept or modify the algorithm recommendations as per his judgment. The new settings will be used during the intervention admission.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • University of Virginia

    lead OTHER

Principal Investigators

  • Ralf Nass, MD · University of Virginia Center for Diabetes Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2025-10-15
Completion
2025-10-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06411548 on ClinicalTrials.gov