A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app).
A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app). The SocialDiabetes app is provided to the intervention group for 4 months. This app has multiple features that allow subjects to monitor their blood glucose and medication, follow an exercise program, and manage their diet. The objective of the study is to evaluate: * The effectiveness of a mobile app on blood glucose control, glycosylated hemoglobin, and the number of hypoglycemic episodes. * Functional status (according to FTS-5 and SPPB). * Quality of life (according to EuroQol-5D and ADDQoL).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
60
The SMART-DIABETES app will be installed on your mobile phone for use for 4 months (+/- 15 days). Initially, the participants will receive specific information and training on how to use the app. The application will have three specific sections: 1. A personalized physical exercise program (16-18 weeks) designed based on the participant's initial physical condition. 2. Dietary advice consisting of daily diets to be followed throughout the study, individualized according to the baseline nutritional assessment. 3. Records and monitoring: Blood glucose, food, medication, activity, HbA1c (with a minimum of 3 daily blood glucose logs for 3 months, it can calculate the estimated HbA1c), weight, heart rate, ketones. * Bolus calculator: quick insulin dose recommendations. * Digital diary that includes all recorded readings. * Carbohydrate calculator: the patient can calculate the number of carbohydrates they will ingest in grams or servings. * Nutritional da
Hospital Universitario Getafe
Getafe, Madrid, Spain
Hospital Universitario Infanta Leonor
Madrid, Madrid, Spain
Centrum för Diabetes
Stockholm, Stockholm County, Sweden
Glycemic control
Glycemic control: 1. Glycated hemoglobin, considering the target of achieving between 7 and 8.5% 2. Number of hypoglycemic episodes (assessed by the number of symptomatic/asymptomatic hypoglycemic episodes per month)
Time frame: From enrollment to the end of treatment at 4 months
Functional status
Assess the functional status of participants according to * FTS-5 (Frailty Trait Scale-5) Scale ranging from 0 to 50, with a score of 30 or higher considered risky to disability * SPPB (The Short Physical Performance Battery) (Score of SPPB scale) 0-4 points: Severe limitation of mobility. 4-6 points: Moderate limitation. 7-9 points: Mild limitation. 10-12 points: Minimal limitation.
Time frame: From enrollment to the end of treatment a 4 months
Quality of life score
Assessed through a general questionnaire * EuroQol-5D (European quality of life measure) The questionnaire describes the current health status of individuals across five dimensions: mobility, self-care, daily activities, pain/discomfort, and anxiety/depression. Each of these dimensions has five possible responses or levels of severity: no problems (1), mild problems (2), moderate problems (3), severe problems (4), and extreme problems/impossibility (5). * ADDQoL (Auditing Diabetes Quality of Life) - Scores range from -9 to +3. A negative score indicates that diabetes is having a harmful effect on that part of your life.
Time frame: From enrollment to the end of treatment at 4 months
Usability
Usability test of the app by patients, families, and healthcare professionals Score of usability \> 80.3: A (Excellent). Users love the system and will recommend it. 68 - 80: B/C (Good/Acceptable). The system is usable, but there is room for improvement. 51 - 67: D (Poor/Acceptable). The system has significant usability problems. \< 50: F (Unacceptable). The system is very difficult to use.
Time frame: From enrollment to the end of treatment at 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
acceptance
* The Technology Acceptance Model (TAM) questionnaire assesses user acceptability of new technology through two primary constructs-Perceived Usefulness (PU) and Perceived Ease of Use (PEU) usually measured on a 5- or 7-point Likert scale. High scores indicate stronger intent to adopt technology, typically with PU having a stronger correlation to usage * The User Experience Questionnaire (UEQ) Measures user experience across six scales (Attractiveness, Perspicuity, Efficiency, Dependability, Stimulation, Novelty) Scores from -3: Extremely negative Scores Between -0.8 and 0.8: Considered neutral (average). Scores \> 0.8: Positive. Scores \> 3: Extremely positive
Time frame: From enrollment to the end of treatment at 4 months
Adverse events
Adverse events during the use of the APP * Number of total hospitalizations * Number of emergency room visits * Total days in hospitalization * Death
Time frame: From enrollment to the end of treatment at 4 months
Economic impact of resource utilization
Use of resources/Economic costs: Hospitalization, length of stay, visits to emergency department, number of visits, used of drugs, jointly to their respective costs in each setting.
Time frame: From enrollment to the end of treatment at 4 months