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FUNDESALUD -More
Category
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Primary study
Registry of Trials»ISRCTN registry
Year
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2026
INTERVENTION: Control arm: Continuous glucose monitoring (Libre3 Abbott), smartwatch Samsung Galaxy (watch 7) and written lifestyle advice Intervention arm: The same as the control arm, and a digital tool (adapted from mKinetikos) with ability to integrate data from continuous glucose monitoring, a smartwatch, scheduled videos of health diet advices, motivational and physical activity, treatment schedule related warnings and a chat to bidirectionally communicate with healthcare workers At each enrollment session at each center, prior to the enrollment day, the selected and scheduled participants, ordered alphabetically by the first letter of their surname, will be randomly assigned a number. Once the number is assigned, in a second randomization process, half of these numbers will be assigned to the intervention arm and the other half to the control arm. If the number of scheduled patients is odd, more or fewer participants will be assigned to each arm at each enrollment center throughout the period, in order to obtain two arms with a similar number of participants. The total duration of intervention and follow‐up will be 14 weeks. CONDITION: Diabetes mellitus ; Nutritional, Metabolic, Endocrine PRIMARY OUTCOME: Glycosylated hemoglobin measured in a sample of peripheral blood at the beginning and after 14 weeks of follow‐up SECONDARY OUTCOME: 1. Self‐management capacity, mainly focused on aspects related to diet, physical activity and therapeutic adherence, measured using DSMQ‐R and Diabetes Self‐Care Activities (DSCA) at the beginning and after 14 weeks of follow‐up; 2. Glycemic variability measured by continuous glucose monitoring (Freestyle Libre 3) during 14 weeks of follow‐up; 3. Weight and body composition: BMI, fat mass, skeletal muscle mass measured with Tanita BC‐545 at the beginning and after 14 weeks of follow‐up; 4. The presence of frailty and whether the condition changes after the intervention, measured using Fried test before and after 14 weeks of follow‐up; 5. The presence of obesity and whether this condition changes after the intervention, measured using the WHO classification of obesity, changes in percentages by class before and after 14 weeks of follow‐up; 6. The usefulness of using devices (wearables) in the process of self‐management of the disease, assessed using the System Usability Scale (SUS) and the mHealth App Usability Questionnaire (MAUQ) at the beginning and after 14 weeks of follow‐up INCLUSION CRITERIA: 1. Patients over 18 years of age 2. Diagnosis of diabetes mellitus (DM): made according to guidelines and with a baseline glycosylated hemoglobin (at the beginning of the study) above 7.5% 3. At least one known vascular risk factor (high blood pressure, dyslipidemia, smoking, obesity or chronic kidney disease) or established vascular disease (coronary disease, cerebrovascular disease or peripheral arterial disease) 4. Ability to use a smartphone‐type mobile device 5. Having signed informed consent (by patient or representative) 6. Score equal to or less than si Xpoints on the Diabetes Self‐Management Questionnaire ‐ Revised (DSMQ‐R) questionnaire
Epistemonikos ID: f7ad6877770fc88cdee4131188f80363a83e1434
First added on: May 06, 2026