Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")
Study Details
Study Description
Brief Summary
Based on international recommendations, the current clinical research project considers the effectiveness of a free diabetes app with a CE (Conformité Européenne) mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1 through a randomized randomized study during 6 months of follow-up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Randomized study in people with type 1 diabetes in intensive insulin therapy MDI with analogues and with HbA1c> 7% to the usual clinical follow-up options (CG) vs use of Social Diabetes App (GI) for 6 months.
The current clinical research project considers the effectiveness of a free diabetes app with a CE mark, "Social Diabetes", which incorporates the addition of a glucometer ("Glucomen Areo") it allows using NFC (Near Field Communication) technology the automatic introduction of data, evaluating the impact on metabolic results and other related psychosocial variables, in people with diabetes 1.
The substitution of the usual face-to-face medical visit every 3-4 months by the incorporation of an app system has a similar effect in terms of glycemic control (measured through HbA1c) in patients with DM1 treated with multiple doses of insulin per day (MDI). ) and inadequate metabolic control (HbA1c> 7%). In addition, it could save costs and consumption of health resources, and improve both the quality of life and the satisfaction of people with DM1.
The present study will be carried out under the usual conditions of clinical practice.
No pharmacological intervention, other than the usual clinical practice, will be applied to the included patients.
The people with diabetes 1 included in the study have a profile of "expert patient" having completed their diabetological education program at basic and advanced level (count of rations, calculations of ratios and sensitivity indexes) in such a way that the application will only be an aid in your daily decision making (mathematical calculations of ratios, IS, and recommended insulin doses, which you usually have to do "by hand").
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group that uses the Social Diabetes App (research group) This group use the App Social diabetes with the glucometer Glucomen Areo to monitoring the glucemia during 6 month |
Device: Social Diabetes App
Social diabetes is an app for diabetes, free with CE mark, that by means of the incorporation of a glucometer ("glucomen Areo") allows through NFC technology the automatic introduction of data in the application
|
| Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments |
Device: Usual clinical monitoring group (Control group)
Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments
|
Outcome Measures
Primary Outcome Measures
- glycosylated hemoglobin [6 month]
Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.
- Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire. [6 month]
34 items to analyze the biopsychosocial impact measured through the quality of life questionnaire (DQol) of a mobile application (Social Diabetes) in the care of people with DM1.
Secondary Outcome Measures
- Mean blood glucose [6 month]
Glycemic control: Mean blood glucose measured in mg / dl
- Standard deviation [6 month]
Glycemic variability: Standard deviation ( SD)
- Number of mild hypoglycaemia [6 month]
Number of mild hypoglycemia in two weeks
- Number of severe hypoglycaemia [6 month]
Number of severe hypoglycaemia in the last 6 months
- Number of hyperglycemia [6 month]
Number of hyperglycemia greater than 250mg / dl in two weeks
- Episodes of ketosis [6 month]
Number of episodes of ketosis in the last 6 months
- Episodes of ketoacidosis [6 month]
Number of episodes of ketoacidosis in the last 6 months
- Number of hospital admissions for glycemic decompensation [6 month]
Number of hospital admissions for glycemic decompensation in the last 6 months.
- Fear of hypoglycemia: Questionnaire FH-15 [6 month]
Fear of hypoglycemia: measured with the FH-15 scale. 15 items related to the fear of hypoglycemia in patients with type 1 diabetes.
- Diabetes treatment satisfaction questionnaire ( DTSQ) [6 month]
8 items concerning the satisfaction of the treatment
- Diabetes distress scale. DDS [6 month]
17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)
- Scale of adherence to treatment in patients with diabetes type 1 [6 month]
15 items related to adherence to patient treatment
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with DM1 over 1 year evolution.
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Age ≥18 and <65 years.
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HbA1c prior to the inclusion of the study> 7%.
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Intensive insulin treatment with MDI in basal-bolus regimen.
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Patients with basic digital skills and with 3G mobile phone and NFC technology.
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Patients who have given their informed consent in writing.
Exclusion Criteria:
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Treatment with subcutaneous insulin infusor (ISCI)
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Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
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Pregnancy or pregnancy planning.
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Diabetes mellitus type 2.
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Severe psychological alterations.
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Absence of collaboration (informed consent).
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Patients who are participating in other clinical studies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Regional University Hospital of Málaga | Málaga | Spain |
Sponsors and Collaborators
- Soledad Ruiz de Adana
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS, Rondán RM, Carreira M, Domínguez-López M, Machado A, Gonzalo-Marín M, Tapia MJ, Valdés S, González-Romero S, Soriguer FC. Development of a new fear of hypoglycemia scale: FH-15. Psychol Assess. 2011 Jun;23(2):398-405. doi: 10.1037/a0021927.
- Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28.
- Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
- Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.
- Chomutare T, Fernandez-Luque L, Arsand E, Hartvigsen G. Features of mobile diabetes applications: review of the literature and analysis of current applications compared against evidence-based guidelines. J Med Internet Res. 2011 Sep 22;13(3):e65. doi: 10.2196/jmir.1874. Review.
- Diabetes Control and Complications Trial Research Group, Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86.
- Franc S, Daoudi A, Mounier S, Boucherie B, Dardari D, Laroye H, Neraud B, Requeda E, Canipel L, Charpentier G. Telemedicine and diabetes: achievements and prospects. Diabetes Metab. 2011 Dec;37(6):463-76. doi: 10.1016/j.diabet.2011.06.006. Epub 2011 Sep 1. Review.
- Frøisland DH, Arsand E, Skårderud F. Improving diabetes care for young people with type 1 diabetes through visual learning on mobile phones: mixed-methods study. J Med Internet Res. 2012 Aug 6;14(4):e111. doi: 10.2196/jmir.2155.
- Gómez EJ, Hernando Pérez ME, Vering T, Rigla Cros M, Bott O, García-Sáez G, Pretschner P, Brugués E, Schnell O, Patte C, Bergmann J, Dudde R, de Leiva A. The INCA system: a further step towards a telemedical artificial pancreas. IEEE Trans Inf Technol Biomed. 2008 Jul;12(4):470-9. doi: 10.1109/TITB.2007.902162.
- Holmen H, Torbjørnsen A, Wahl AK, Jenum AK, Småstuen MC, Arsand E, Ribu L. A Mobile Health Intervention for Self-Management and Lifestyle Change for Persons With Type 2 Diabetes, Part 2: One-Year Results From the Norwegian Randomized Controlled Trial RENEWING HEALTH. JMIR Mhealth Uhealth. 2014 Dec 11;2(4):e57. doi: 10.2196/mhealth.3882.
- Holtz B, Lauckner C. Diabetes management via mobile phones: a systematic review. Telemed J E Health. 2012 Apr;18(3):175-84. doi: 10.1089/tmj.2011.0119. Epub 2012 Feb 22. Review.
- Kirwan M, Vandelanotte C, Fenning A, Duncan MJ. Diabetes self-management smartphone application for adults with type 1 diabetes: randomized controlled trial. J Med Internet Res. 2013 Nov 13;15(11):e235. doi: 10.2196/jmir.2588.
- Krishna S, Boren SA, Balas EA. Healthcare via cell phones: a systematic review. Telemed J E Health. 2009 Apr;15(3):231-40. doi: 10.1089/tmj.2008.0099. Review.
- Lee E, Tatara N, Arsand E, Hartvigsen G. Review of mobile terminal-based tools for diabetes diet management. Stud Health Technol Inform. 2011;169:23-7. Review.
- Lewis TL, Boissaud-Cooke MA, Aungst TD, Eysenbach G. Consensus on use of the term "App" versus "Application" for reporting of mHealth research. J Med Internet Res. 2014 Jul 17;16(7):e174; discussion e174. doi: 10.2196/jmir.3460.
- Liang X, Wang Q, Yang X, Cao J, Chen J, Mo X, Huang J, Wang L, Gu D. Effect of mobile phone intervention for diabetes on glycaemic control: a meta-analysis. Diabet Med. 2011 Apr;28(4):455-63. doi: 10.1111/j.1464-5491.2010.03180.x.
- Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94.
- Mulvaney SA, Ritterband LM, Bosslet L. Mobile intervention design in diabetes: review and recommendations. Curr Diab Rep. 2011 Dec;11(6):486-93. doi: 10.1007/s11892-011-0230-y. Review.
- Piette JD. Interactive behavior change technology to support diabetes self-management: where do we stand? Diabetes Care. 2007 Oct;30(10):2425-32. Epub 2007 Jun 22.
- Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. doi: 10.2337/dc11-0366. Epub 2011 Jul 25. Erratum in: Diabetes Care. 2013 Nov;36(11):3850.
- Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002 May 18;324(7347):1193-4.
- Vahatalo M. Cellular phone transferred self blood glucose monitoring: Prerequisites for positive outcome. Practical Diabetes International 2004;21(5):192-194.
- Waki K, Fujita H, Uchimura Y, Omae K, Aramaki E, Kato S, Lee H, Kobayashi H, Kadowaki T, Ohe K. DialBetics: A Novel Smartphone-based Self-management Support System for Type 2 Diabetes Patients. J Diabetes Sci Technol. 2014 Mar;8(2):209-215. Epub 2014 Mar 13.
- Wei J, Hollin I, Kachnowski S. A review of the use of mobile phone text messaging in clinical and healthy behaviour interventions. J Telemed Telecare. 2011;17(1):41-8. doi: 10.1258/jtt.2010.100322. Epub 2010 Nov 19. Review.
- Whitehead L, Seaton P. The Effectiveness of Self-Management Mobile Phone and Tablet Apps in Long-term Condition Management: A Systematic Review. J Med Internet Res. 2016 May 16;18(5):e97. doi: 10.2196/jmir.4883. Review.
- Social Diabetes