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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01337141
• Other study ID #: CIBERDEM-TELEMED-DIABETES
• Status: Completed
• Phase: N/A
• First received: April 14, 2011
• Last updated: January 28, 2015
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2015
• Source: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Metabolic Diseases
• Metabolic Disorder

Intervention

Other:
• Control
7 face-to-face visits.

Device:
• Telecare system
5 telematic visits and 2 face-to-face visits.

Locations

Country	Name	City	State
Spain	Hospital de Cruces	Barakaldo
Spain	Hospital Clínic de Barcelona	Barcelona
Spain	Hospital Clínico de Madrid	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Clínico de Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Medical team costs	Time, expenses and healthcare issues used in the follow-up phase of the metabolic control.	Month6	No
Secondary	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	No
Secondary	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	No

External Links

•   CIBERDEM website, including a description of TELEMED-DIABETES