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

NCT07591415 | Completed

• 1 other identifier: 2024-NDMH-5173
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

Brief Summary

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

Conditions

Diabetes; Diabetes Mellitus; Elderly; ELDERLY PEOPLE

Keywords

Movile application; Diabetes Mellitus; elderly

Outcome Measures

Primary Outcomes (3)

• 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)

  From enrollment to the end of treatment at 4 months

• 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.

  From enrollment to the end of treatment a 4 months

• 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.

  From enrollment to the end of treatment at 4 months

Secondary Outcomes (4)

• Usability

  From enrollment to the end of treatment at 4 months

• acceptance

  From enrollment to the end of treatment at 4 months

• Adverse events

  From enrollment to the end of treatment at 4 months

• Economic impact of resource utilization

  From enrollment to the end of treatment at 4 months

Study Arms (2)

intervention arm. SMARTDIABETES

EXPERIMENTAL

SMARTDIABETES app

Other: Smartdiabetes

Control

NO INTERVENTION

Normal live, without App

Interventions

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: 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

Also known as: The SMART-DIABETES app

intervention arm. SMARTDIABETES

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Leocadio Rodriguez Mañas: lead
• Hospital Universitario Getafe: collaborator
• MG Biomed: collaborator
• SocialDiabetes: collaborator

Study Sites (3)

Hospital Universitario Getafe

Getafe, Madrid, 28905, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, Madrid, 28031, Spain

Location

Centrum för Diabetes

Stockholm, Stockholm County, 113 65, Sweden

Location

Related Publications (10)

• 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.

  PMID: 36580558 BACKGROUND

• 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.

  PMID: 30419096 BACKGROUND

• 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.

  PMID: 35545258 BACKGROUND

• 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.

  PMID: 31016897 BACKGROUND

• 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.

  PMID: 34640777 BACKGROUND

• 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.

  PMID: 32528409 BACKGROUND

• 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.

  PMID: 32946822 BACKGROUND

• 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.

  PMID: 30632972 BACKGROUND

• 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.

  PMID: 35708894 BACKGROUND

• 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.

  PMID: 30843865 BACKGROUND

Related Links

• Description of the study

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leocadio Rodriguez Mañas

  Hospital Universitario de Getafe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Model Details: Multicenter, international, randomized, drug-free clinical trial of a mobile application compared to a control (no application)

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: May 15, 2026
• Study Start: January 31, 2025
• Primary Completion: June 17, 2025
• Study Completion: October 30, 2025
• Last Updated: May 15, 2026

Record last verified: 2025-02

Locations

SE (1); ES (2)