A Telematic Program for Optimization of Metabolic Control in Diabetes Mellitus Type 1 (DM1) Patients

Summary

A greater visit frequency between the diabetes mellitus 1 (DM1) patient and the medical team increases the possibilities to improve metabolic control. The support of telematic visits can support the patient and the health system.

Patients and Method: 160 patients (from 5 participating centres) with type 1 diabetes mellitus (DM1) candidates for improved metabolic control selected according to inclusion and exclusion criteria. The telecare system used is comprised of the patient Unit and the doctor Unit. The system allows the patient to send glucose values, insulin doses, carbohydrate contribution and other events via the internet. Both the patient and the professional can use this information via the telecare system platform.

Work hypothesis

The application of interactive telematic systems between patient-health team will improve the cost effectiveness of care programmes for optimisation of metabolic control directed towards diabetes mellitus (DM1) patients.

Objectives:

General Objective Evaluate the impact of the telecare system on the efficiency of economic and clinical management of human and material resources directed to a program of metabolic control optimisation in diabetes mellitus 1 (DM1) patients as well as the level of metabolic control and the quality of life of the patients.

Specific objectives

1. To identify and analyse the influence of the telecare system on patient costs in time, money and normal work or school activity which the patient has to stop to carry out the physical visits for following the programme.
2. To identify and analyse the influence of the telecare system on medical team costs in time, money and care organisation directed towards the monitoring phase of the metabolic control care programme.
3. To identify and analyse the influence of the telecare system on the level of metabolic control: Glycosylated haemoglobin and the presence of acute hypoglycemic and hyperglycaemic complications in diabetes mellitus 1 (DM1) patients that follow the metabolic optimisation programme.
4. To identify and analyse the influence of the telecare system on the quality of life of the patient measured in satisfaction scale, impact, social/work concern and concern relating to diabetes.
5. To identify and analyse the influence of the telecare system on the adherence to different treatment components.

Conditions

• Diabetes Mellitus, Type 1
• Metabolic Disorder

Interventions

OTHER

Control

7 face-to-face visits.

DEVICE

Telecare system

5 telematic visits and 2 face-to-face visits.

Sponsors & Collaborators

• Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

  lead OTHER

Principal Investigators

• Enric Esmatjes, MD and PhD · Hospital Clínic de Barcelona (CIBERDEM)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-05-31

Primary Completion

2012-04-30

Completion

2012-11-30

Countries

• Spain

Study Locations