Clinical trial NCT03332472: Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN)
Official title: Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telemedicine
Keywords: type 1 diabetes
Lead sponsor: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of a 6-month telemedicine program (DiabeTIC) in patients with type 1 diabetes mellitus (DM1) and regular metabolic control (HbA1c \<8%) in multi-dose insulin treatment (MDI) measured HbA1c vs. conventional medical care.

Detailed description: The substitution of face-to-face visits for telematics visits has a similar effect on glycemic control (measured by HbA1c) in patients with DM1 treated with multiple daily doses of insulin (MDI) and regular metabolic control (HbA1c \<8 %). It even saves costs and consumption of health resources, and improves the quality of life and satisfaction of subjects with DM1

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)

Eligibility criteria: Inclusion Criteria:

* Patients with DM1 over 2 years of evolution.
* 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:

* Treatment with ISCI.
* 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.

Primary outcomes:
measure: HbA1c
timeFrame: 6 months
Secondary outcomes:
measure: Total daily dose of insulin
timeFrame: 6 months
measure: Total daily dose of insulin by weight
timeFrame: 6 months
measure: Number of mild hypoglycaemia
timeFrame: 6 months
measure: Number of severe hypoglycemia
timeFrame: 6 months
measure: Number of hyperglycemia greater than 250 mg / dl / week
timeFrame: 6 months
measure: Number of episodes of ketosis number of episodes of ketoacidosis
timeFrame: 6 months
measure: Number of hospital admissions due to glycemic decompensations
timeFrame: 6 months
measure: Fear of hypoglycemia: FH-15 scale
timeFrame: 6 months
measure: Quality of life
timeFrame: 6 months
measure: Stress: DDS questionnaire
timeFrame: 6 months
measure: Time invested in the care of each patient
timeFrame: 6 months
measure: Number of telephone calls
timeFrame: 6 months
measure: Number of face-to-face visits
timeFrame: 6 months
measure: Analytics performed in the center
timeFrame: 6 months
measure: Analytic done in domestic scope with glucometer
timeFrame: 6 months
measure: Cost of hypoglycaemic treatment (insulin)
timeFrame: 6 months
measure: Costs and consumption of health resources
timeFrame: 6 months
measure: Costs associated with the time spent going to the patient's hospital and family members
timeFrame: 6 months
measure: Costs associated with days lost due to complications.
timeFrame: 6 months
measure: Mean blood glucose
timeFrame: 6 months
measure: Standard deviation
timeFrame: 6 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga. Unidad de Diabetes
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
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.
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. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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. doi: 10.2337/diacare.27.5.1088.
citation: 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.
citation: 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.
citation: 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.