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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Time in Range (TIR) — During the last 2 weeks of intervention
  Time in Range (TIR), defined as the percentage of time that interstitial glucose is between 70-180 mg/dL during the final 2 weeks of the intervention phase
• Usability and adherence — Two weeks
  Patient-reported outcomes on usability and adherence through uMARS. The usability of the app will be evaluated using the Spanish Version of the User Version of the Mobile Application Rating Scale (uMARS). This scale provides a comprehensive and objective measure of app usability and consists of 20 items. Each item is rated on a 5-point scale, ranging from 1 (inadequate) to 5 (excellent).

Trial sites (2)

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