NCT03332472

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

Evaluation of Telemedicine on Metabolic Control in the Care of Diabetes Mellitus Type 1 Patients in Multiple Doses of Insulin Treatment in Andalusian Community

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 334 (actual)
• Sponsor: Sociedad Andaluza de Endocrinología, Diabetes y Nutrición · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Telemedicine

Interventions

Type	Name	Description
OTHER	Telemedicine group
OTHER	Conventional group

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-11-01
• Completion: 2016-12-01
• First posted: 2017-11-06
• Last updated: 2017-11-06

Locations

1 site across 1 country: Spain