Clinical trial NCT01337141: A Telematic Program for Optimization of Metabolic Control in Diabetes Mellitus Type 1 (DM1) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Metabolic Disorder
Keywords: Telemedicine
Type 1 diabetes
Metabolic control optimisation
Health care costs
Intervention study
Access to internet
Lead sponsor: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Sponsor class: OTHER
First posted: 2011-04-18
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: \*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.

Eligibility criteria: 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).

Primary outcomes:
measure: Optimise metabolic control
timeFrame: Month 12
Secondary outcomes:
measure: Patient costs
timeFrame: Month 6
measure: Medical team costs
timeFrame: Month6
measure: Quality of life
timeFrame: Month 12
measure: Treatment adherence
timeFrame: Month 12
Other outcomes:
Locations:
city: Barakaldo
country: Spain
facility: Hospital de Cruces
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Madrid
country: Spain
facility: Hospital Clínico de Madrid
city: Malaga
country: Spain
facility: Hospital Carlos Haya
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
Study officials:
affiliation: Hospital Clínic de Barcelona (CIBERDEM)
name: Enric Esmatjes, MD and PhD
role: PRINCIPAL_INVESTIGATOR
References: