Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Predicti… (NCT07304778) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of a Mobile AI-powered Decision Support System for Insulin Dosing and Glucose Prediction in Type 1 Diabetes: The glUCModel Clinical Trial Protocol
Spain34 participantsStarted 2025-07-11
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time in Range (TIR)
Timeframe: During the last 2 weeks of intervention