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Completed

NCT Number: NCT07591415

Validation of an App in the Elderly Population With Diabetes Mellitus.

A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app).

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Key information

Conditions

Diabetes Diabetes Mellitus Elderly Elderly People Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

70 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Getafe, Getafe, Madrid, Spain

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smartdiabetes

Other

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:

  • A personalized physical exercise program (16-18 weeks) designed based on the participant's initial physical condition.
  • Dietary advice consisting of daily diets to be followed throughout the study, individualized according to the baseline nutritional assessment.
  • 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

Other names: The SMART-DIABETES app

Primary outcomes

  1. Glycemic control

    Time frame: From enrollment to the end of treatment at 4 months

    Glycemic control:

    • Glycated hemoglobin, considering the target of achieving between 7 and 8.5%
    • Number of hypoglycemic episodes (assessed by the number of symptomatic/asymptomatic hypoglycemic episodes per month)

  2. Functional status

    Time frame: 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.

  3. Quality of life score

    Time frame: 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 outcomes

  1. Usability

    Time frame: 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.

  2. acceptance

    Time frame: 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

  3. Adverse events

    Time frame: 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

  4. Economic impact of resource utilization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Leocadio Rodriguez Mañas

Other

Collaborators

  • Hospital Universitario Getafe
  • MG Biomed
  • SocialDiabetes

Registry information

Acronym: SMARTDIABETES

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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