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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
ClinicalTrials.gov Identifier:
NCT01337141
First received: April 14, 2011
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

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.

Condition Intervention
Diabetes Mellitus, Type 1
Metabolic Disorder
Other: Control
Device: Telecare system

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

Resource links provided by NLM:


Further study details as provided by Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders:

Primary Outcome Measures:
  • Optimise metabolic control [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    • 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


Secondary Outcome Measures:
  • Patient costs [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Time, expenses and ordinary activity (studies and work) that the patient could not do in order to attend to the face-to-face visits.

  • Medical team costs [ Time Frame: Month6 ] [ Designated as safety issue: No ]
    Time, expenses and healthcare issues used in the follow-up phase of the metabolic control.

  • Quality of life [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) and standardised instrument for use as a measure of health outcome (EuroQoL).

  • Treatment adherence [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Self-Care Inventory-revised (SCI-R), a self-report measure of perceived adherence to diabetes self-care recommendations, among adults with diabetes.


Enrollment: 154
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 Name: Control group do not use telematic system.

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

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01337141

Locations
Spain
Hospital de Cruces
Barakaldo, Spain, 48903
Hospital Clínic de Barcelona
Barcelona, Spain, 08036
Hospital Clínico de Madrid
Madrid, Spain, 28040
Hospital Carlos Haya
Malaga, Spain, 29010
Hospital Clínico de Valencia
Valencia, Spain, 46010
Sponsors and Collaborators
Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
Investigators
Principal Investigator: Enric Esmatjes, MD and PhD Hospital Clínic de Barcelona (CIBERDEM)
  More Information

No publications provided

Responsible Party: Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders
ClinicalTrials.gov Identifier: NCT01337141     History of Changes
Other Study ID Numbers: CIBERDEM-TELEMED-DIABETES
Study First Received: April 14, 2011
Last Updated: January 21, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders:
Telemedicine
Type 1 diabetes
Metabolic control optimisation
Health care costs
Intervention study
Access to internet

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 30, 2014