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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 23, 2014