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

May 11, 2026 updated by: Leocadio Rodriguez Mañas
A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Hospital Universitario Getafe
      • Madrid, Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 113 65
        • Centrum för Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention arm. SMARTDIABETES
SMARTDIABETES app
Other: Smartdiabetes

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
Other Names:
  • The SMART-DIABETES app
No Intervention: Control
Normal live, without App

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: 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)
From enrollment to the end of treatment at 4 months
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.
From enrollment to the end of treatment a 4 months
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.
From enrollment to the end of treatment at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of treatment at 4 months
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
From enrollment to the end of treatment at 4 months
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
From enrollment to the end of treatment at 4 months
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.
From enrollment to the end of treatment at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Leocadio Rodriguez Mañas

Collaborators

Hospital Universitario Getafe
MG Biomed
SocialDiabetes

Investigators

  • Principal Investigator: Leocadio Rodriguez Mañas, Hospital Universitario de Getafe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2025

Primary Completion (Actual)

June 17, 2025

Study Completion (Actual)

October 30, 2025

Study Registration Dates

First Submitted

March 4, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-NDMH-5173

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We will need to reach a consensus among all participants in the research group.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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