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

January 28, 2015 updated by: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barakaldo, Spain, 48903
        • Hospital De Cruces
      • Barcelona, Spain, 08036
        • Hospital Clínic de Barcelona
      • Madrid, Spain, 28040
        • Hospital Clínico de Madrid
      • Malaga, Spain, 29010
        • Hospital Carlos Haya
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional telematic
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
5 telematic visits and 2 face-to-face visits.
Other Names:
  • Medical Guard Diabetes®
  • - Access in internet: https://www.medicalguard.net/
  • - Pulso Ediciones SL
Other: Control
80 patients will be included in this arm. They will receive 7 face-to-face visits (not telematic).
Other: Control
7 face-to-face visits.
Other Names:
  • Control group do not use telematic system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimise metabolic control
Time Frame: Month 12
  • 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 Frame: Month 6
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 Frame: Month6
Time, expenses and healthcare issues used in the follow-up phase of the metabolic control.
Month6
Quality of life
Time Frame: Month 12
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
Time Frame: Month 12
Self-Care Inventory-revised (SCI-R), a self-report measure of perceived adherence to diabetes self-care recommendations, among adults with diabetes.
Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders

Investigators

  • Principal Investigator: Enric Esmatjes, MD and PhD, Hospital Clínic de Barcelona (CIBERDEM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

April 14, 2011

First Submitted That Met QC Criteria

April 15, 2011

First Posted (Estimate)

April 18, 2011

Study Record Updates

Last Update Posted (Estimate)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIBERDEM-TELEMED-DIABETES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on Telecare system

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe