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

Sociedad Andaluza de Endocrinología, Diabetes y Nutrición

Status

Completed

Conditions

Telemedicine

Treatments

Other: Conventional group

Other: Telemedicine group

Study type

Interventional

Funder types

Other

Identifiers

NCT03332472

PLATEDIAN

Details and patient eligibility

About

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.

Full 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)

Enrollment

334 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.