AzTrials
AzTrials

Diabetes Mellitus, Type 1NCT01337141

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

A study testing Telecare system in people with Diabetes Mellitus, Type 1 and Metabolic Disorder, run by Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders at 5 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Diabetes Mellitus, Type 1, Metabolic Disorder
What is being tested?
Telecare system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
5 sitesSpain
Study dates
May 2011to Nov 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Spain5 sites

  • Hospital de Cruces

    Barakaldo, Spain, 48903

  • Hospital Clínic de Barcelona

    Barcelona, Barcelona, 08036

  • Hospital Clínico de Madrid

    Madrid, Madrid, 28040

  • Hospital Carlos Haya

    Málaga, Spain, 29010

  • Hospital Clínico de Valencia

    Valencia, Spain, 46010

Other trials in Spain

About this study

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

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.

Read more

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.
Read the 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.

Being tested
Control, Telecare system
Keywords
Telemedicine, Type 1 diabetes, Metabolic control optimisation, Health care costs, Intervention study, Access to internet
Medical subject headings
Diabetes Mellitus, Type 1, Metabolic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ControlOther

    Also called Control group do not use telematic system.

    7 face-to-face visits.

  • Telecare systemDevice

    Also called Medical Guard Diabetes®, - Access in internet: https://www.medicalguard.net/, - Pulso Ediciones SL

    5 telematic visits and 2 face-to-face visits.

Study groups in NCT01337141
Study groupRoleWhat they receive
Interventional telematicExperimental80 patients will be included in this arm. They will receive 5 telematic visits (Telecare system) and 2 face to face visits.
Receives: Device: Telecare system
ControlOther80 patients will be included in this arm. They will receive 7 face-to-face visits (not telematic).
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Month 12

Secondary outcomes (4)

  1. 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.

    Measured: Month 6

  2. Medical team costs

    Time, expenses and healthcare issues used in the follow-up phase of the metabolic control.

    Measured: Month6

  3. Quality of life

    Quality-of-life questionnaire designed for diabetes mellitus (EsDQOL) and standardised instrument for use as a measure of health outcome (EuroQoL).

    Measured: Month 12

  4. Treatment adherence

    Self-Care Inventory-revised (SCI-R), a self-report measure of perceived adherence to diabetes self-care recommendations, among adults with diabetes.

    Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2011 (estimated)
  2. Study startMay 2011
  3. Primary completionApr 2012
  4. Study completionNov 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01337141
Sponsor's protocol ID
CIBERDEM-TELEMED-DIABETES
Status last verified
Jan 2015
First submitted
14 Apr 2011
Last updated
29 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Telecare system in people with Diabetes Mellitus, Type 1 and Metabolic Disorder, run by Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders at 5 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Optimise metabolic control (time frame: Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01337141.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in