Clinical Study to Evaluate the Bio-Psychosocial Impact of Mobile App for Diabetes Type 1 ("SOCIAL DIABETES")

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Randomized Clinical Study to Evaluate the Bio-Psychosocial Impact of a Mobile App for Diabetes ("SOCIAL DIABETES") and a SMARTMETER® (A. MENARINI DIAGNOSTICS) in the Care of People With Diabetes Mellitus Type 1 and Its Associated Costs

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03455816
• Other study ID #: Social Diabetes
• Status: Recruiting
• Phase: N/A
• First received: February 28, 2018
• Last updated: March 11, 2018
• Start date: July 7, 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: Maria Soledad Ruiz de Adana, MD PhD
• Phone: +34 629221089
• Email: solruizdeadana[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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").

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients with DM1 over 1 year evolution.

• Age =18 and <65 years.

• HbA1c prior to the inclusion of the study> 7%.

• Intensive insulin treatment with MDI in basal-bolus regimen.

• Patients with basic digital skills and with 3G mobile phone and NFC technology.

• Patients who have given their informed consent in writing.

Exclusion Criteria:

• Treatment with subcutaneous insulin infusor (ISCI)

• Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).

• Pregnancy or pregnancy planning.

• Diabetes mellitus type 2.

• Severe psychological alterations.

• Absence of collaboration (informed consent).

• Patients who are participating in other clinical studies.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Regional University Hospital of Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Soledad Ruiz de Adana

Country where clinical trial is conducted

Spain, 

References & Publications (25)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Stone AA, Shiffman S, Schwartz JE, Broderick JE, Hufford MR. Patient non-compliance with paper diaries. BMJ. 2002 May 18;324(7347):1193-4. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycosylated hemoglobin	Metabolic impact measured through HbA1c of a mobile application (Social Diabetes) in the care of people with DM1.	6 month
Primary	Quality of life assessment: Diabetes Quality of Life (DQoL) questionnaire.	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.	6 month
Secondary	Mean blood glucose	Glycemic control: Mean blood glucose measured in mg / dl	6 month
Secondary	Standard deviation	Glycemic variability: Standard deviation ( SD)	6 month
Secondary	Number of mild hypoglycaemia	Number of mild hypoglycemia in two weeks	6 month
Secondary	Number of severe hypoglycaemia	Number of severe hypoglycaemia in the last 6 months	6 month
Secondary	Number of hyperglycemia	Number of hyperglycemia greater than 250mg / dl in two weeks	6 month
Secondary	Episodes of ketosis	Number of episodes of ketosis in the last 6 months	6 month
Secondary	Episodes of ketoacidosis	Number of episodes of ketoacidosis in the last 6 months	6 month
Secondary	Number of hospital admissions for glycemic decompensation	Number of hospital admissions for glycemic decompensation in the last 6 months.	6 month
Secondary	Fear of hypoglycemia: Questionnaire FH-15	Fear of hypoglycemia: measured with the FH-15 scale. 15 items related to the fear of hypoglycemia in patients with type 1 diabetes.	6 month
Secondary	Diabetes treatment satisfaction questionnaire ( DTSQ)	8 items concerning the satisfaction of the treatment	6 month
Secondary	Diabetes distress scale. DDS	17 items on the problems and stress that people with type 1 diabetes suffer (Polonski y col,2005)	6 month
Secondary	Scale of adherence to treatment in patients with diabetes type 1	15 items related to adherence to patient treatment	6 month

External Links

•   Smith A. Pew Internet & American Life Project. Washington, DC 20036: Pew Research Center; 2012 Mar 01. Nearly half of American adults are Smart phone owners