Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients (TELEDIAB-3)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01447940
First received: October 3, 2011
Last updated: November 15, 2013
Last verified: November 2013
  Purpose

Primary objective of TELEDIAB-3 study is to demonstrate that the use of Meos Telemedicine ePortal for sharing information between diabetologist and type 1 diabetic patient is not inferior to a conventional care regarding metabolic results at 12 months.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Device: Meos ePortal use
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • HbA1c measured at 12 months in Meos ePoral group versus conventional care group. Non-inferiority level is defined at a 0.15% threshold for an expected HbA1c of 8.5% at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c measured at 6 months in each group [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HbA1c measured at 12 months in each group [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Annual cost of diabetes care from hospital and health insurance' points of view [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life at inclusion and 12 months, using the Diabetes Health Profile (DHP-1) scale and the Satisfaction items of the Diabetes Quality of Life (DQOL) questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: January 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Conventional Care
Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal
Device: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Other Names:
  • Telemedicine
  • ePortal
Experimental: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Device: Meos ePortal use
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Other Names:
  • Telemedicine
  • ePortal

Detailed Description:

Meos is the name of the website (Telemedicine ePortal) tested in this trial ; it is used to share informations between diabetologist and type 1 diabetic patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with type 1 diabetes mellitus for ≥ 12 months or more
  • Age > 18 years old
  • Patient who is followed since 6 month into investigator hospital
  • Patient with available internet access at least once a week, and ability to understand MEOS website navigation
  • Patient using a compatible glucose meter (One touch ultra, Optium xceed, or BG star)

Exclusion Criteria:

  • Patient with no easy and regular access to the Internet;
  • Patient found to be unfit for use of the telematic tools or e-mail tools
  • Patient with toxicomania, alcoholism or psychological troubles
  • Type 2 diabetic patients
  • Patient who does not need strict metabolic objectives
  • Pregnant or parturient women
  • Person with no freedom (prisoner)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447940

Contacts
Contact: Jean-Luc Bosson, MD +33476769260 JLBosson@chu-grenoble.fr
Contact: Myriam Haddouche +33476765040 MHaddouche@chu-grenoble.fr

Locations
France
University Hospital of Caen (Hospital Côte de nacre) Recruiting
Caen, Basse-Normandie, France, 14033
Contact: Yves REZNIK, Pr    +332 31 06 45 75    reznik-y@chu-caen.fr   
Principal Investigator: Yves Reznik, Pr         
Sub-Investigator: Michael Joubert, MD         
University Hospital of Besancon - Hospital Jean Minjoz Recruiting
Besancon, Franche Comté, France, 25030
Contact: Alfred Penfornis, Pr    +333 81 66 81 92    alfred.penfornis@univ-fcomte.fr   
Principal Investigator: Alfred Penfornis, Pr         
Hospital Sud Francilien Recruiting
Corbeil Essonne, Ile de France, France, 91100
Contact: Guillaume CHARPENTIER    +331 60 90 30 86    kerbonac@free.fr   
Principal Investigator: Guillaume Charpentier, MD         
Hospital University of Montpellier Recruiting
Montpellier, Languedoc-Roussillon, France, 34295
Contact: Anne Farret, MD    +334 67 33 83 83    a-farret@chu-montpellier.fr   
Principal Investigator: Eric Renard, Pr         
Sub-Investigator: Anne Farret, MD         
University Hospital of Reims Recruiting
Reims, Marne, France, 51110
Contact: Céline Lukas-Croisier, Dr    +333 26 78 33 42    clukas-croisier@chu-reims.fr   
Principal Investigator: Hélène Hanaire, Pr         
University Hospital of Nantes Recruiting
Nantes, Pays-de-la-Loire, France, 44093
Contact: Lucy Chaillous, MD    +332 40 08 36 42    lucy.chaillous@chu-nantes.fr   
Principal Investigator: Lucy Chaillous, MD         
University Hospital, Department of Endocrinology Recruiting
Grenoble, Rhône-Alpes, France, 38043
Contact: Benhamou Pierre-Yves, Pr    + 33 476769349    PYBenhamou@chu-grenoble.fr   
Principal Investigator: Pierre-Yves Benhamou, Pr         
University Hospital of Lyon (HCL Lyon sud) Recruiting
Lyon, Rhônes-Alpes, France, 69310
Contact: Charles Thivolet, Pr    +334 78 86 14 87    charles.thivolet@chu-lyon.fr   
Principal Investigator: Charles Thivolet, Pr         
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Pierre-Yves Benhamou, Pr University Hospital, Grenoble
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01447940     History of Changes
Other Study ID Numbers: DCIC10 20
Study First Received: October 3, 2011
Last Updated: November 15, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Telemedicine
Type 1 diabetes
economic cost of Type 1 diabetes
ePortal Meos

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

ClinicalTrials.gov processed this record on April 17, 2014