Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01447940
First received: October 3, 2011
Last updated: December 8, 2014
Last verified: December 2014
  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: December 2015
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

Locations
France
University Hospital of Caen (Hospital Côte de nacre)
Caen, Basse-Normandie, France, 14033
University Hospital of Besancon - Hospital Jean Minjoz
Besancon, Franche Comté, France, 25030
Hospital Sud Francilien
Corbeil Essonne, Ile de France, France, 91100
Hospital University of Montpellier
Montpellier, Languedoc-Roussillon, France, 34295
University Hospital of Reims
Reims, Marne, France, 51110
University Hospital of Nantes
Nantes, Pays-de-la-Loire, France, 44093
University Hospital, Department of Endocrinology
Grenoble, Rhône-Alpes, France, 38043
University Hospital of Lyon (HCL Lyon sud)
Lyon, Rhônes-Alpes, France, 69310
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: December 8, 2014
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
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015