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

This study is currently recruiting participants.

Verified April 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: April 9, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2011

Last Updated Date

April 9, 2013

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

HbA1c measured at 12 months in MEOS platform 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 ]

Change History

Complete list of historical versions of study NCT01447940 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 DHP scale and the Satisfaction item of the 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

Official Title ^ICMJE

Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Diabetes Mellitus, Type 1

Intervention ^ICMJE

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

Study Arm (s)

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

Intervention: Device: Meos ePortal use
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

Intervention: Device: Meos ePortal use

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

720

Estimated Completion Date

July 2015

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01447940

Other Study ID Numbers ^ICMJE

DCIC10 20

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Grenoble

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pierre-Yves Benhamou, Pr

University Hospital, Grenoble

Information Provided By

University Hospital, Grenoble

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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