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DiabetesSMARTDIABETESNCT07591415

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

A study testing Smartdiabetes in people with Diabetes and Diabetes Mellitus, run by Leocadio Rodriguez Mañas at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 70 years and older
Conditions the study is for
Diabetes, Diabetes Mellitus, Elderly
What is being tested?
Smartdiabetes
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesin 2 countries
Study dates
31 Jan 2025to 30 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Adult ≥ 70 years
  • Diagnosed with diabetes mellitus (DM)
  • Have a mobile phone compatible with the app

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Spain2 sites

  • Hospital Universitario Getafe

    Getafe, Madrid, 28905

  • Hospital Universitario Infanta Leonor

    Madrid, Madrid, 28031

Other trials in Spain

Sweden1 site

  • Centrum för Diabetes

    Stockholm, Stockholm County, 113 65

Other trials in Sweden

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).

Read the 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).
Being tested
Smartdiabetes
Keywords
Movile application, Diabetes Mellitus, elderly
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SmartdiabetesOther

    Also called The SMART-DIABETES 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
Study groups in NCT07591415
Study groupRoleWhat they receive
intervention arm. SMARTDIABETESExperimentalSMARTDIABETES app
Receives: Other: Smartdiabetes
ControlNo interventionNormal live, without App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From enrollment to the end of treatment at 4 months

  2. 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.

    Measured: From enrollment to the end of treatment a 4 months

  3. 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.

    Measured: From enrollment to the end of treatment at 4 months

Secondary outcomes (4)

  1. 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.

    Measured: From enrollment to the end of treatment at 4 months

  2. 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

    Measured: From enrollment to the end of treatment at 4 months

  3. Adverse events

    Adverse events during the use of the APP

    • Number of total hospitalizations
    • Number of emergency room visits
    • Total days in hospitalization
    • Death

    Measured: From enrollment to the end of treatment at 4 months

  4. 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.

    Measured: From enrollment to the end of treatment at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2026
  2. Study start31 Jan 2025
  3. Primary completion17 Jun 2025
  4. Study completion30 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Multicenter, international, randomized, drug-free clinical trial of a mobile application compared to a control (no application)
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07591415
Sponsor's protocol ID
2024-NDMH-5173
Acronym
SMARTDIABETES
Status last verified
Feb 2025
First submitted
4 Mar 2026
Last updated
15 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: We will need to reach a consensus among all participants in the research group.

Publications

  • Sanchez-Sanchez JL, de Souto Barreto P, Anton-Rodrigo I, Ramon-Espinoza F, Marin-Epelde I, Sanchez-Latorre M, Moral-Cuesta D, Casas-Herrero A. Effects of a 12-week Vivifrail exercise program on intrinsic capacity among frail cognitively impaired community-dwelling older adults: secondary analysis of a multicentre randomised clinical trial. Age Ageing. 2022 Dec 5;51(12):afac303. doi: 10.1093/ageing/afac303.

    PubMed 36580558

  • Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.

    PubMed 30419096

  • Bernabei R, Landi F, Calvani R, Cesari M, Del Signore S, Anker SD, Bejuit R, Bordes P, Cherubini A, Cruz-Jentoft AJ, Di Bari M, Friede T, Gorostiaga Ayestaran C, Goyeau H, Jonsson PV, Kashiwa M, Lattanzio F, Maggio M, Mariotti L, Miller RR, Rodriguez-Manas L, Roller-Wirnsberger R, Ryznarova I, Scholpp J, Schols AMWJ, Sieber CC, Sinclair AJ, Skalska A, Strandberg T, Tchalla A, Topinkova E, Tosato M, Vellas B, von Haehling S, Pahor M, Roubenoff R, Marzetti E; SPRINTT consortium. Multicomponent intervention to prevent mobility disability in frail older adults: randomised controlled trial (SPRINTT project). BMJ. 2022 May 11;377:e068788. doi: 10.1136/bmj-2021-068788.

    PubMed 35545258

  • Rodriguez-Manas L, Laosa O, Vellas B, Paolisso G, Topinkova E, Oliva-Moreno J, Bourdel-Marchasson I, Izquierdo M, Hood K, Zeyfang A, Gambassi G, Petrovic M, Hardman TC, Kelson MJ, Bautmans I, Abellan G, Barbieri M, Pena-Longobardo LM, Regueme SC, Calvani R, De Buyser S, Sinclair AJ; European MID-Frail Consortium. Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus. J Cachexia Sarcopenia Muscle. 2019 Aug;10(4):721-733. doi: 10.1002/jcsm.12432. Epub 2019 Apr 23.

    PubMed 31016897

  • Perez-Rodriguez R, Villalba-Mora E, Valdes-Aragones M, Ferre X, Moral C, Mas-Romero M, Abizanda-Soler P, Rodriguez-Manas L. Usability, User Experience, and Acceptance Evaluation of CAPACITY: A Technological Ecosystem for Remote Follow-Up of Frailty. Sensors (Basel). 2021 Sep 27;21(19):6458. doi: 10.3390/s21196458.

    PubMed 34640777

  • Perez-Rodriguez R, Guevara-Guevara T, Moreno-Sanchez PA, Villalba-Mora E, Valdes-Aragones M, Oviedo-Briones M, Carnicero JA, Rodriguez-Manas L. Monitoring and Intervention Technologies to Manage Diabetic Older Persons: The CAPACITY Case-A Pilot Study. Front Endocrinol (Lausanne). 2020 May 13;11:300. doi: 10.3389/fendo.2020.00300. eCollection 2020.

    PubMed 32528409

  • Munshi MN, Meneilly GS, Rodriguez-Manas L, Close KL, Conlin PR, Cukierman-Yaffe T, Forbes A, Ganda OP, Kahn CR, Huang E, Laffel LM, Lee CG, Lee S, Nathan DM, Pandya N, Pratley R, Gabbay R, Sinclair AJ. Diabetes in ageing: pathways for developing the evidence base for clinical guidance. Lancet Diabetes Endocrinol. 2020 Oct;8(10):855-867. doi: 10.1016/S2213-8587(20)30230-8.

    PubMed 32946822

  • Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM, Shaw J, Bouck Z, Jamieson T, Onabajo N, Cooper M, Marani H, Jeffs L, Bhatia RS. Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10321. doi: 10.2196/10321.

    PubMed 30632972

  • Liu Z, Wang C, Yang D, Luo S, Ding Y, Xu W, Zheng X, Weng J, Yan J. High engagement in mobile peer support is associated with better glycemic control in type 1 diabetes: A real-world study. J Diabetes Investig. 2022 Nov;13(11):1914-1924. doi: 10.1111/jdi.13870. Epub 2022 Jul 2.

    PubMed 35708894

  • Vehi J, Regincos Isern J, Parcerisas A, Calm R, Contreras I. Impact of Use Frequency of a Mobile Diabetes Management App on Blood Glucose Control: Evaluation Study. JMIR Mhealth Uhealth. 2019 Mar 7;7(3):e11933. doi: 10.2196/11933.

    PubMed 30843865

Questions about this trial

What is this clinical trial studying?

A study testing Smartdiabetes in people with Diabetes and Diabetes Mellitus, run by Leocadio Rodriguez Mañas at 3 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glycemic control (time frame: From enrollment to the end of treatment at 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07591415, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.

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