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

Study Overview
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Brief Summary
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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 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. 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. 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. 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. To identify and analyse the influence of the telecare system on the adherence to different treatment components.

Detailed Description
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*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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1, Metabolic Disorder

Intervention / Treatment
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* Other: Control
* Device: Telecare system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes Mellitus 1 (DM1) patients with more than 5 years of evolution with values of glycosylated haemoglobin (HbA1c) > 8% aged between 18 and 50 years. 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: Pregnant diabetes mellitus 1 (DM1) patients. 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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional telematic<br>80 patients will be included in this arm. They will receive 5 telematic visits (Telecare system) and 2 face to face visits. | Device: Telecare system<br>* 5 telematic visits and 2 face-to-face visits.<br>* Other names: - Pulso Ediciones SL;|
| Other: Control<br>80 patients will be included in this arm. They will receive 7 face-to-face visits (not telematic). | Other: Control<br>* 7 face-to-face visits.<br>* Other names: Control group do not use telematic system.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimise metabolic control | Insulin dose and criteria (timetables, habits of diet and activity). Autocontrol description and survey about perception of hypoglycaemia Knowledge about diabetes: Diabetes knowledge questionnaire (DKQ2) <25/35 | Month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient costs | Time, expenses and ordinary activity (studies and work) that the patient could not do in order to attend to the face-to-face visits. | Month 6 | 
| Medical team costs | Time, expenses and healthcare issues used in the follow-up phase of the metabolic control. | Month6 | 
| Quality of life | Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) and standardised instrument for use as a measure of health outcome (EuroQoL). | Month 12 | 
| Treatment adherence | Self-Care Inventory-revised (SCI-R), a self-report measure of perceived adherence to diabetes self-care recommendations, among adults with diabetes. | Month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemedicine, Type 1 diabetes, Metabolic control optimisation, Health care costs, Intervention study, Access to internet