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| Name | Class |
|---|---|
| Hospital Universitario Getafe | OTHER |
| MG Biomed | UNKNOWN |
| SocialDiabetes | UNKNOWN |
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A randomized clinical trial comparing the intervention group, which will use a mobile app, with the control group (without a mobile app).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm. SMARTDIABETES | Experimental | SMARTDIABETES app |
|
| Control | No Intervention | Normal live, without App |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | Glycemic control:
| From enrollment to the end of treatment at 4 months |
| Functional status | Assess the functional status of participants according to
| From enrollment to the end of treatment a 4 months |
| Quality of life score | Assessed through a general questionnaire
| From enrollment to the end of treatment at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leocadio Rodriguez Mañas | Hospital Universitario de Getafe | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Getafe | Getafe | Madrid | 28905 | Spain | ||
| Hospital Universitario Infanta Leonor |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36580558 | Background | 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. | |
| 30419096 |
| Label | URL |
|---|---|
| Description of the study | View source |
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We will need to reach a consensus among all participants in the research group.
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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Multicenter, international, randomized, drug-free clinical trial of a mobile application compared to a control (no application)
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|
|
| From enrollment to the end of treatment at 4 months |
| acceptance |
| From enrollment to the end of treatment at 4 months |
| Adverse events | Adverse events during the use of the APP
| From enrollment to the end of treatment at 4 months |
| 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. | From enrollment to the end of treatment at 4 months |
| Madrid |
| Madrid |
| 28031 |
| Spain |
| Centrum för Diabetes | Stockholm | Stockholm County | 113 65 | Sweden |
| 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. |
| 35545258 | 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. |
| 31016897 | 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. |
| 34640777 | 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. |
| 32528409 | 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. |
| 32946822 | 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. |
| 30632972 | 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. |
| 35708894 | 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. |
| 30843865 | 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. |