Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)
NCT ID: NCT03332472
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
334 participants
INTERVENTIONAL
2013-12-31
2016-12-31
Brief Summary
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Detailed Description
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To evaluate the effect of a 6-month Diabetic platform on telemedicine in patients with DM1 and regular metabolic control (HbA1c \<8%) on MDI treatment in the following parameters:
A) Glycemic control: Mean glycemia, number of mild hypoglycemia / week, number of severe hypoglycemia / 6 months, number of hyperglycemia greater than 250mg / dl / week, number of episodes of ketosis / 6 months, number of episodes of ketoacidosis / 6meses , Number of hospital admissions due to glycemic decompensation / 6 months.
B) Glycemic variability: Standard deviation, mean amplitude of glycemic excursions (MAGE).
C) Fear of hypoglycemia: scale FH-15. D) Quality of life: Diabetes Quality of Life Questionnaire (DQoL). E) Stress: DDS questionnaire.
F) Costs and consumption of health resources:
-Cost-effectiveness (HbA1C)
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telemedicine group
Telematics visit in front of the conventional visit face to face
Telemedicine group
Conventional group
Group with conventional medical visit
Conventional group
Interventions
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Telemedicine group
Conventional group
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 and \<65 years.
* HbA1c prior to inclusion of the study \<8% (the measure being valid in the month prior to inclusion in the study)
* Intensive insulin therapy with basal-bolus MDI.
* Patients living in Andalusian
* Patients candidates for telemonitoring.
* Patients who have received written informed consent.
Exclusion Criteria
* Chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled).
* Pregnancy or pregnancy planning.
* Diabetes mellitus type 2.
* Severe psychological disturbances.
* Absence of collaboration (informed consent).
* Patients who are participating in other clinical studies.
18 Years
65 Years
ALL
No
Sponsors
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Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
OTHER
Responsible Party
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Locations
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Hospital Regional Universitario de Málaga. Unidad de Diabetes
Málaga, , Spain
Countries
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References
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Effect of intensive diabetes treatment on the development and progression of long-term complications in adolescents with insulin-dependent diabetes mellitus: Diabetes Control and Complications Trial. Diabetes Control and Complications Trial Research Group. J Pediatr. 1994 Aug;125(2):177-88. doi: 10.1016/s0022-3476(94)70190-3.
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
Biermann E, Dietrich W, Standl E. Telecare of diabetic patients with intensified insulin therapy. A randomized clinical trial. Stud Health Technol Inform. 2000;77:327-32.
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.
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.
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. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
Gomez EJ, Hernando ME, Garcia A, Del Pozo F, Cermeno J, Corcoy R, Brugues E, De Leiva A. Telemedicine as a tool for intensive management of diabetes: the DIABTel experience. Comput Methods Programs Biomed. 2002 Aug;69(2):163-77. doi: 10.1016/s0169-2607(02)00039-1.
Rigla M, Hernando ME, Gomez EJ, Brugues E, Garcia-Saez G, Torralba V, Prados A, Erdozain L, Vilaverde J, de Leiva A. A telemedicine system that includes a personal assistant improves glycemic control in pump-treated patients with type 1 diabetes. J Diabetes Sci Technol. 2007 Jul;1(4):505-10. doi: 10.1177/193229680700100408.
Bellazzi R, Larizza C, Montani S, Riva A, Stefanelli M, d'Annunzio G, Lorini R, Gomez EJ, Hernando E, Brugues E, Cermeno J, Corcoy R, de Leiva A, Cobelli C, Nucci G, Del Prato S, Maran A, Kilkki E, Tuominen J. A telemedicine support for diabetes management: the T-IDDM project. Comput Methods Programs Biomed. 2002 Aug;69(2):147-61. doi: 10.1016/s0169-2607(02)00038-x.
Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702. doi: 10.2337/diacare.28.11.2697.
Jansa M, Vidal M, Viaplana J, Levy I, Conget I, Gomis R, Esmatjes E. Telecare in a structured therapeutic education programme addressed to patients with type 1 diabetes and poor metabolic control. Diabetes Res Clin Pract. 2006 Oct;74(1):26-32. doi: 10.1016/j.diabres.2006.03.005. Epub 2006 Apr 18.
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. doi: 10.2337/diacare.27.5.1088.
Rossi MC, Nicolucci A, Di Bartolo P, Bruttomesso D, Girelli A, Ampudia FJ, Kerr D, Ceriello A, Mayor Cde L, Pellegrini F, Horwitz D, Vespasiani G. Diabetes Interactive Diary: a new telemedicine system enabling flexible diet and insulin therapy while improving quality of life: an open-label, international, multicenter, randomized study. Diabetes Care. 2010 Jan;33(1):109-15. doi: 10.2337/dc09-1327. Epub 2009 Oct 6.
Anarte Ortiz MT, Caballero FF, Ruiz de Adana MS, Rondan RM, Carreira M, Dominguez-Lopez M, Machado A, Gonzalo-Marin M, Tapia MJ, Valdes S, Gonzalez-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.
Ruiz de Adana MS, Alhambra-Exposito MR, Munoz-Garach A, Gonzalez-Molero I, Colomo N, Torres-Barea I, Aguilar-Diosdado M, Carral F, Serrano M, Martinez-Brocca MA, Duran A, Palomares R; Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition). Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study. Diabetes Care. 2020 Feb;43(2):337-342. doi: 10.2337/dc19-0739. Epub 2019 Dec 12.
Other Identifiers
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PLATEDIAN
Identifier Type: -
Identifier Source: org_study_id