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

RecruitingNAAges 18 Years - 65 YearsAllUniversidad Complutense de Madrid
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In plain words

What the trial is, and whether it could suit you

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 treatme

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๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • glUCModel app
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Where

2 sites
Universidad Complutense de Madrid
Madrid, Spain
Hospital Universitario de Toledo
Toledo, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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