NCT07304778Recruiting
Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol
Source: ClinicalTrials.gov · Last updated 6 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- First submitted
- 30 Nov 2025
- Start date
- 11 Jul 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Universidad Complutense de Madrid
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT07304778
What you commit to
- Study type: Interventional
- Planned participants: 34
- From 11 Jul 2025 to the primary completion date, 1 Feb 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subjects in treatment with corticoids
- Patients who have required hospitalization or surgery in the last six months.
Other illness
- Less than one year since the time of diabetes diagnosis
- Unable to follow a Portion-controlled diet for diabetes
- Diagnosed with a significant psychiatric disorder.
Lab values
- HbA1c \< 9%.
Other
- Not wearing CGMs.
- Non-Spanish language proficiency.
- Unable to use a mobile application like glUCModel
- Unable to do an active management of insulin dosing.
- Pregnancy or planning a pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidad Complutense de Madrid Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario de Toledo Coordinator of this site? Confirm its status | Toledo | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.