NCT07304778 Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol
| NCT ID | NCT07304778 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad Complutense de Madrid |
| Condition | Diabetes (Insulin-requiring, Type 1 or Type 2) |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-07-11 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-07-11 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07304778 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Diabetes (Insulin-requiring, Type 1 or Type 2). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304778 currently recruiting?
Yes, NCT07304778 is actively recruiting participants. Contact the research team at hidalgo@dacya.ucm.es for enrollment information.
Where is the NCT07304778 trial being conducted?
This trial is being conducted at Madrid, Spain, Toledo, Spain.
Who is sponsoring the NCT07304778 clinical trial?
NCT07304778 is sponsored by Universidad Complutense de Madrid. The trial plans to enroll 34 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.