A Telematic Program for Optimization of Metabolic Control in Diabetes Mellitus Type 1 (DM1) Patients
NCT ID: NCT01337141
Last Updated: 2015-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
154 participants
INTERVENTIONAL
2011-05-31
2012-11-30
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Interventional telematic
80 patients will be included in this arm. They will receive 5 telematic visits (Telecare system) and 2 face to face visits.
Telecare system
5 telematic visits and 2 face-to-face visits.
Control
80 patients will be included in this arm. They will receive 7 face-to-face visits (not telematic).
Control
7 face-to-face visits.
Interventions
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Control
7 face-to-face visits.
Telecare system
5 telematic visits and 2 face-to-face visits.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Undergoing treatment with multiple doses of insulin.
* Having 3-4 blood sugar tests per day.
* Suitable knowledge about diabetes (test of Diabetes knowledge questionnaire (DKQ2)\>25).
* Patients with a computer and access to home internet.
Exclusion Criteria
* History of severe hypoglycemia.
* Manipulation of results.
* Psychiatric disorder.
* Incapable of carrying out intensive therapy monitoring.
* Physical and/or visual incapacity.
* Participating in another study.
* Patients with infertility treatment (ISCI).
18 Years
50 Years
ALL
No
Sponsors
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Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
OTHER
Responsible Party
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Principal Investigators
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Enric Esmatjes, MD and PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Clínic de Barcelona (CIBERDEM)
Locations
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Hospital Clínic de Barcelona
Barcelona, Barcelona, Spain
Hospital Clínico de Madrid
Madrid, Madrid, Spain
Hospital de Cruces
Barakaldo, Spain, Spain
Hospital Carlos Haya
Málaga, Spain, Spain
Hospital Clínico de Valencia
Valencia, Spain, Spain
Countries
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Related Links
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CIBERDEM website, including a description of TELEMED-DIABETES
Other Identifiers
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CIBERDEM-TELEMED-DIABETES
Identifier Type: -
Identifier Source: org_study_id
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