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

11. maj 2026 opdateret af: 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).

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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).

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: intervention arm. SMARTDIABETES
SMARTDIABETES app

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
Andre navne:
  • The SMART-DIABETES app
Ingen indgriben: Control
Normal live, without App

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Glycemic control
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Usability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Leocadio Rodriguez Mañas, Hospital Universitario de Getafe

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. januar 2025

Primær færdiggørelse (Faktiske)

17. juni 2025

Studieafslutning (Faktiske)

30. oktober 2025

Datoer for studieregistrering

Først indsendt

4. marts 2026

Først indsendt, der opfyldte QC-kriterier

11. maj 2026

Først opslået (Faktiske)

15. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. maj 2026

Sidst verificeret

1. februar 2025

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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