NCT01337141

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. 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. 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. 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. 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. 5.To identify and analyse the influence of the telecare system on the adherence to different treatment components.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

April 14, 2011

Last Update Submit

January 28, 2015

Conditions

Diabetes Mellitus, Type 1Metabolic Disorder

Keywords

TelemedicineType 1 diabetesMetabolic control optimisationHealth care costsIntervention studyAccess to internet

Outcome Measures

Primary Outcomes (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

    Month 12

Secondary Outcomes (4)

  • Patient costs

    Month 6

  • Medical team costs

    Month6

  • Quality of life

    Month 12

  • Treatment adherence

    Month 12

Study Arms (2)

Interventional telematic

EXPERIMENTAL

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

Control

OTHER

80 patients will be included in this arm. They will receive 7 face-to-face visits (not telematic).

Other: Control

Interventions

ControlOTHER

7 face-to-face visits.

Also known as: Control group do not use telematic system.
Control
Telecare systemDEVICE

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

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

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Clínic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Hospital Clínico de Madrid

Madrid, Madrid, 28040, Spain

Location

Hospital de Cruces

Barakaldo, Spain, 48903, Spain

Location

Hospital Carlos Haya

Málaga, Spain, 29010, Spain

Location

Hospital Clínico de Valencia

Valencia, Spain, 46010, Spain

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Metabolic Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Enric Esmatjes, MD and PhD

    Hospital Clínic de Barcelona (CIBERDEM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2011

First Posted

April 18, 2011

Study Start

May 1, 2011

Primary Completion

April 1, 2012

Study Completion

November 1, 2012

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations

ES(5)