Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients (PLATEDIAN) (PLATEDIAN)

• ClinicalTrials.gov Identifier: NCT03332472
• Recruitment Status: Completed
• First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Sponsor: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
• Information provided by (Responsible Party): Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Telemedicine	Other: Telemedicine group; Other: Conventional group	Not Applicable

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)

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 334 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: December 2013
• Actual Primary Completion Date: November 2014
• Actual Study Completion Date: December 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telemedicine group; Telematics visit in front of the conventional visit face to face	Other: Telemedicine group
Placebo Comparator: Conventional group; Group with conventional medical visit	Other: Conventional group

Outcome Measures

Primary Outcome Measures :

1. HbA1c [ Time Frame: 6 months ]
   Glycosylated hemoglobin

Secondary Outcome Measures :

1. Total daily dose of insulin [ Time Frame: 6 months ]
   total daily doseof insulin (IU/day)
2. Total daily dose of insulin by weight [ Time Frame: 6 months ]
   Total daily dose by weight (IU / kg / day)
3. Number of mild hypoglycaemia [ Time Frame: 6 months ]
   Acude complications prior to V1: number of mild hypoglycaemia
4. Number of severe hypoglycemia [ Time Frame: 6 months ]
   Acute complications prior to V1: number of severe hypoglycemia
5. Number of hyperglycemia greater than 250 mg / dl / week [ Time Frame: 6 months ]
   Acute complications prior to V1: number of hyperglycemia greater than 250 mg / dl / week
6. Number of episodes of ketosis number of episodes of ketoacidosis [ Time Frame: 6 months ]
   Acute complications prior to V1: number of episodes of ketosis and number of episodes of ketoacidosis
7. Number of hospital admissions due to glycemic decompensations [ Time Frame: 6 months ]
   Acute complications prior to V1:number of hospital admissions due to glycemic decompensations.
8. Fear of hypoglycemia: FH-15 scale [ Time Frame: 6 months ]
   Hypoglycemia Fear test: FH-15 questionnaire (Annex)
9. Quality of life [ Time Frame: 6 months ]
   Diabetes Quality of Life Questionnaire (DQoL).
10. Stress: DDS questionnaire [ Time Frame: 6 months ]
    Diabetes Distress Scale (DDS) (Polonski et al, 2005)
11. Time invested in the care of each patient [ Time Frame: 6 months ]
    Costs and consumption of health resources: Time invested in the care of each patient in minutes
12. Number of telephone calls [ Time Frame: 6 months ]
    Costs and consumption of health resources: Number of telephone calls
13. Number of face-to-face visits [ Time Frame: 6 months ]
    Costs and consumption of health resources: Number of face-to-face visits
14. Analytics performed in the center [ Time Frame: 6 months ]
    Costs and consumption of health resources: Analytics performed in the center
15. Analytic done in domestic scope with glucometer [ Time Frame: 6 months ]
    Costs and consumption of health resources:Number of analytic done in domestic scope with glucometer
16. Cost of hypoglycaemic treatment (insulin) [ Time Frame: 6 months ]
    Costs and consumption of health resources: Cost in of hypoglycaemic treatment (insulin) in euros.
17. Costs and consumption of health resources [ Time Frame: 6 months ]
    Costs and consumption of health resources: Cost of number of admissions in emergencies and number of hospitalizations
18. Costs associated with the time spent going to the patient's hospital and family members [ Time Frame: 6 months ]
    Costs and consumption of health resources: costs associated with the time spent going to the patient's hospital and family members
19. Costs associated with days lost due to complications. [ Time Frame: 6 months ]
    Costs and consumption of health resources: costs associated with days lost due to complications.
20. Mean blood glucose [ Time Frame: 6 months ]
    Glycemic control: Mean blood glucose (mg / dL)
21. Standard deviation [ Time Frame: 6 months ]
    Glycemic control: Standard deviation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Hospital Regional Universitario de Málaga. Unidad de Diabetes

Málaga, Spain, 29010

Sponsors and Collaborators

Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

More Information

Publications:

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición
• ClinicalTrials.gov Identifier: NCT03332472
• Other Study ID Numbers: PLATEDIAN
• First Posted: November 6, 2017
• Last Update Posted: November 6, 2017
• Last Verified: November 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Sociedad Andaluza de Endocrinología, Diabetes y Nutrición:

type 1 diabetes

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases