- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07591415
Validation of an App in the Elderly Population With Diabetes Mellitus. (SMARTDIABETES)
Studieoversigt
Status
Betingelser
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
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
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
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:
Andre navne:
|
|
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:
|
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
|
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
|
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
|
|
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
|
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
Sponsor
Efterforskere
- Ledende efterforsker: Leocadio Rodriguez Mañas, Hospital Universitario de Getafe
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2024-NDMH-5173
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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