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Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol

NCT07304778 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2026-01-06

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and efficacy of integrating predictive models into insulin therapy management via the user-centered glUCModel mobile app in People with Type 1 Diabetes Mellitus following Multiple Insulin Dosing therapy. Participants will be aged 18 to 65 years. The main questions it aims to answer are:

Does using the app improve glycaemic control, as measured by time in range? Does using the app reduce the number of episodes of hyperglycaemia and hypoglycaemia? Are the app's design and functionality adequate?

The study will comprise four phases:ses}):

* Screening phase: Informed consent, collection of sociodemographic and clinical data, and baseline Pittsburg, IFIS, and DTSQ questionnaires.
* Run-in phase: 2 weeks of standard care with CGM. Data will be used to generate personalized predictive models in the intervention group.
* Active treatment phase: Participants continue MDI therapy. The intervention group will additionally use the glUCModel mobile app. CGM data from the final 2 weeks will be analyzed.
* Evaluation and analysis phase: Participants will complete the uMARS, Pittsburgh, and DTSQ questionnaires. Statistical analysis and correlations among outcomes will be processed.

Conditions

  • Diabetes (Insulin-requiring, Type 1 or Type 2)

Interventions

OTHER

glUCModel app

The intervention consists on using glUCModel, an application designed to help people with diabetes. It features a suite of artificial intelligence tools and statistical techniques for capturing and managing key information that people with diabetes need to track, as well as for predicting glucose values to aid users in informed decision-making.

Sponsors & Collaborators

  • Bioinspired Intelligence SL

    collaborator UNKNOWN

  • Hospital de Toledo

    collaborator UNKNOWN

  • Universidad Complutense de Madrid

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-11
Primary Completion
2026-02-01
Completion
2026-06-01

Countries

  • Spain

Study Locations

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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 NCT07304778 on ClinicalTrials.gov