Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Multicentric Intervention Study Evaluating the Efficiency of the Implementation in the Spanish Health System of a Telematic System Applied to Metabolic Control Optimization for Type 1 Diabetes Mellitus (DM1) Patients
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.
*Title: Multicentric random, prospective, open and comparative intervention study evaluating
the efficiency of the implementation in the Spanish Health System of a telematic system
applied to metabolic control optimization for type 1 diabetes mellitus (DM1) patients.
- Protocol:
1) Pre-intervention. After the patient is informed and accepts the protocol they make 2
visits for planning individual treatment. 2) Random Assignment in 2 Groups: A)
Intervention (telecare system). B) Control. The intervention group patients will be
trained in the telecare system machine. Both groups will make the same number of 6
visits over 6 months: Intervention Group (5 telematics and 1 hospital), Control group
(6 hospital). Results will be assessed at 3 and 6 months and reassessed at 12 months.
- Patients The objective of the present study is to demonstrate that telematic control of
diabetes mellitus is not inferior to the face to face visit control system, while
showing an added value an important reduction in costs. Cost information from three
studies have been used for the calculation of the sample 2,3,20 in diabetes mellitus 1
(DM1) patients, some followed in a telematic form (210 ± 184€) and other in the form of
face to face visits (376 ± 278€). Relating to this, 72 patients per group are needed to
obtain a statistical power of 99% and an alpha level of 0.05 (two-sided). 80 patients
per group will be needed to be randomised taking into account a 10% loss percentage.
Participating Centres
- Hospital Clínico. Barcelona
- Hospital Clínico. Valencia
- Hospital Carlos Haya. Málaga
- Hospital Clínico. Madrid
- Hospital de Cruces. Barakaldo
Each arm will include 80 patients, 160 as a total.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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