Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

Mobile AI app to predict glucose and suggest insulin bolus doses for people on multiple daily injections

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

Run by Universidad Complutense de Madrid · NCT07304778 · Data updated 2026-11-12

This study will test whether a smartphone AI app can help adults with insulin-requiring diabetes on multiple daily injections predict blood sugar and suggest bolus doses to increase time-in-range and reduce highs and lows.

More Diabetes (Insulin-requiring, Type 1 or Type 2) trials

Quick facts

Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment34 (estimated)
SponsorUniversidad Complutense de Madrid
Academic / other
Locations2 sites (Madrid, Madrid and 1 other locations)
StatusRecruiting
StartedJuly 11, 2025
Main results expectedFebruary 1, 2026
Study endsJune 1, 2026
Registry record updatedJanuary 6, 2026
Trial IDNCT07304778 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are Spanish-speaking adults (18–65) with insulin-requiring diabetes on multiple daily injections, using a CGM, with HbA1c below 9%, at least one year since diagnosis, and able to use a smartphone app and follow portion-controlled diet guidance.

Probably not a fit

Patients not on multiple daily injections, not using CGM, non–Spanish speakers, those with poor control (e.g., HbA1c ≥9%), on systemic corticosteroids, with recent hospitalization or major surgery, or with significant psychiatric disorders are unlikely to benefit from this intervention.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–65 on multiple daily insulin injections will be screened, complete a 2-week run-in with continuous glucose monitoring (CGM), and then be followed during an active treatment phase where one group uses the glUCModel app in addition to usual care. The app uses personalized predictive models generated from run-in CGM data to provide bolus dosing recommendations and short-term glucose forecasts. Key outcomes include change in time-in-range, frequency of hypoglycaemia and hyperglycaemia, and user-centered measures of app usability and design. Participants must be Spanish-speaking, able to use a smartphone and CGM, and have at least one year since diagnosis.

Why it matters

Potential benefit: If successful, the app could increase the proportion of time patients spend in their glucose target range and reduce episodes of dangerous low and high blood sugar.

How similar studies have gone: Previous small pilots of predictive glucose models and insulin decision-support tools have shown promising improvements in time-in-range and dose guidance, but larger randomized data are still limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* HbA1c \< 9%
* Currently following an MDI Bolus-Basal therapy.

  * Wearing CGMs connected to a mobile phone.
  * Spanish language proficiency.
  * Willingness to participate in the trial.
  * At least one year since the time of diabetes diagnosis.
  * Ability to use a mobile application like glUCModel.
  * Own a mobile phone running Android or iOS operating system.
  * Ability to follow a Portion-controlled diet for diabetes.
  * Educated to do an active management of insulin dosing

Exclusion Criteria:

* HbA1c \< 9%.
* Not wearing CGMs.
* Non-Spanish language proficiency.
* Less than one year since the time of diabetes diagnosis
* Unable to use a mobile application like glUCModel
* Unable to follow a Portion-controlled diet for diabetes
* Unable to do an active management of insulin dosing.
* Diagnosed with a significant psychiatric disorder.
* Subjects in treatment with corticoids
* Patients who have required hospitalization or surgery in the last six months.
* Pregnancy or planning a pregnancy

Where it's running

  • Hospital Universitario de Toledo
    Toledo, Toledo, Spain
    Recruiting
  • Universidad Complutense de Madrid
    Madrid, Madrid, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.