Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
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
Sponsors
FUNDESALUD
JACARDI (Joint Action on Cardiovascular diseases and diabetes)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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 six points on the Diabetes Self-Management Questionnaire - Revised (DSMQ-R) questionnaire
Exclusion criteria
Exclusion criteria: 1. Patients with DM but without other risk factors or associated established vascular disease 2. Score greater than six points on the DSMQ-R questionnaire 3. Patients with neurological diseases or tumors in advanced stages, who are unable to adequately carry out a basic physical activity program 4. Patient participating in a clinical trial of pharmacological intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin measured in a sample of peripheral blood at the beginning and after 14 weeks of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Spain
Contacts
Public ContactJosé Carlos Arévalo Lorido
Outcome results
None listed