Diabetes, Diabetes Mellitus, Elderly, ELDERLY PEOPLE
Conditions
Keywords
Movile application, Diabetes Mellitus, elderly
Brief summary
A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app).
Detailed description
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).
Interventions
OTHERSmartdiabetes
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
Sponsors
Leocadio Rodriguez Mañas
Hospital Universitario Getafe
MG Biomed
SocialDiabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Multicenter, international, randomized, drug-free clinical trial of a mobile application compared to a control (no application)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult ≥ 70 years * Diagnosed with diabetes mellitus (DM) * Have a mobile phone compatible with the app
Exclusion criteria
* Cognitive impairment that prevents proper use of the app (MOCA scale score of 16 or less). * Visual impairments that prevent proper use of the app, using the standardized Snellen chart (score less than 40/20) at a distance of 20 feet.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | From enrollment to the end of treatment at 4 months | 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) |
| Functional status | From enrollment to the end of treatment a 4 months | 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. |
| Quality of life score | From enrollment to the end of treatment at 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability | From enrollment to the end of treatment at 4 months | 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. |
| acceptance | From enrollment to the end of treatment at 4 months | * 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 |
| Adverse events | From enrollment to the end of treatment at 4 months | Adverse events during the use of the APP * Number of total hospitalizations * Number of emergency room visits * Total days in hospitalization * Death |
| Economic impact of resource utilization | From enrollment to the end of treatment at 4 months | 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. |
Countries
Spain, Sweden
Contacts
PRINCIPAL_INVESTIGATORLeocadio Rodriguez Mañas
Hospital Universitario de Getafe
Outcome results
None listed