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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Meos ePortal use
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 1 focused on measuring Telemedicine, Type 1 diabetes, economic cost of Type 1 diabetes, ePortal Meos

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University Hospital of Caen (Hospital Côte de nacre)
  • University Hospital of Besancon - Hospital Jean Minjoz
  • Hospital Sud Francilien
  • Hospital University of Montpellier
  • University Hospital of Reims
  • University Hospital of Nantes
  • University Hospital, Department of Endocrinology
  • University Hospital of Lyon (HCL Lyon sud)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Conventional Care

Meos ePortal use

Arm Description

Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal

Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months

Outcomes

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

Secondary Outcome Measures

HbA1c measured at 6 months in each group
HbA1c measured at 12 months in each group
HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)
HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)
Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up
Annual cost of diabetes care from hospital and health insurance' points of view
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
Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire

Full Information

First Posted
October 3, 2011
Last Updated
December 8, 2014
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT01447940
Brief Title
Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
Acronym
TELEDIAB-3
Official Title
Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Telemedicine, Type 1 diabetes, economic cost of Type 1 diabetes, ePortal Meos

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
720 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Care
Arm Type
Placebo Comparator
Arm Description
Patients will have conventional care with 2 standard visits (inclusion and 12 months) + HbA1c measure at 6 months. Patients won't use Meos ePortal
Arm Title
Meos ePortal use
Arm Type
Experimental
Arm Description
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Intervention Type
Device
Intervention Name(s)
Meos ePortal use
Other Intervention Name(s)
Telemedicine, ePortal
Intervention Description
Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
HbA1c measured at 6 months in each group
Time Frame
6 months
Title
HbA1c measured at 12 months in each group
Time Frame
12 months
Title
HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)
Time Frame
6 months
Title
HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)
Time Frame
12 months
Title
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
Title
Annual cost of diabetes care from hospital and health insurance' points of view
Time Frame
12 months
Title
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
Title
Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves Benhamou, Pr
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Caen (Hospital Côte de nacre)
City
Caen
State/Province
Basse-Normandie
ZIP/Postal Code
14033
Country
France
Facility Name
University Hospital of Besancon - Hospital Jean Minjoz
City
Besancon
State/Province
Franche Comté
ZIP/Postal Code
25030
Country
France
Facility Name
Hospital Sud Francilien
City
Corbeil Essonne
State/Province
Ile de France
ZIP/Postal Code
91100
Country
France
Facility Name
Hospital University of Montpellier
City
Montpellier
State/Province
Languedoc-Roussillon
ZIP/Postal Code
34295
Country
France
Facility Name
University Hospital of Reims
City
Reims
State/Province
Marne
ZIP/Postal Code
51110
Country
France
Facility Name
University Hospital of Nantes
City
Nantes
State/Province
Pays-de-la-Loire
ZIP/Postal Code
44093
Country
France
Facility Name
University Hospital, Department of Endocrinology
City
Grenoble
State/Province
Rhône-Alpes
ZIP/Postal Code
38043
Country
France
Facility Name
University Hospital of Lyon (HCL Lyon sud)
City
Lyon
State/Province
Rhônes-Alpes
ZIP/Postal Code
69310
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
12716807
Citation
Chase HP, Pearson JA, Wightman C, Roberts MD, Oderberg AD, Garg SK. Modem transmission of glucose values reduces the costs and need for clinic visits. Diabetes Care. 2003 May;26(5):1475-9. doi: 10.2337/diacare.26.5.1475.
Results Reference
background
PubMed Identifier
16249542
Citation
Farmer AJ, Gibson OJ, Dudley C, Bryden K, Hayton PM, Tarassenko L, Neil A. A randomized controlled trial of the effect of real-time telemedicine support on glycemic control in young adults with type 1 diabetes (ISRCTN 46889446). Diabetes Care. 2005 Nov;28(11):2697-702. doi: 10.2337/diacare.28.11.2697.
Results Reference
background
PubMed Identifier
15111526
Citation
Montori VM, Helgemoe PK, Guyatt GH, Dean DS, Leung TW, Smith SA, Kudva YC. Telecare for patients with type 1 diabetes and inadequate glycemic control: a randomized controlled trial and meta-analysis. Diabetes Care. 2004 May;27(5):1088-94. doi: 10.2337/diacare.27.5.1088.
Results Reference
background
PubMed Identifier
17395516
Citation
Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
Results Reference
background
PubMed Identifier
17475533
Citation
Boizel R, Benhamou PY, Renard E; Accu-Chek Pocket Compass Study Group. Glucose monitoring and pump data management software operated on a personal digital assistant can contribute to improve diabetes control in CSII-treated patients. Diabetes Metab. 2007 Sep;33(4):314-5. doi: 10.1016/j.diabet.2007.03.001. Epub 2007 May 1. No abstract available.
Results Reference
background
PubMed Identifier
15677779
Citation
Young RJ, Taylor J, Friede T, Hollis S, Mason JM, Lee P, Burns E, Long AF, Gambling T, New JP, Gibson JM. Pro-active call center treatment support (PACCTS) to improve glucose control in type 2 diabetes: a randomized controlled trial. Diabetes Care. 2005 Feb;28(2):278-82. doi: 10.2337/diacare.28.2.278.
Results Reference
background
PubMed Identifier
15142919
Citation
Ralston JD, Revere D, Robins LS, Goldberg HI. Patients' experience with a diabetes support programme based on an interactive electronic medical record: qualitative study. BMJ. 2004 May 15;328(7449):1159. doi: 10.1136/bmj.328.7449.1159.
Results Reference
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PubMed Identifier
17130195
Citation
Cho JH, Chang SA, Kwon HS, Choi YH, Ko SH, Moon SD, Yoo SJ, Song KH, Son HS, Kim HS, Lee WC, Cha BY, Son HY, Yoon KH. Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30-month follow-up study for diabetes management with a ubiquitous medical care system. Diabetes Care. 2006 Dec;29(12):2625-31. doi: 10.2337/dc05-2371.
Results Reference
background
PubMed Identifier
12684363
Citation
Tate DF, Jackvony EH, Wing RR. Effects of Internet behavioral counseling on weight loss in adults at risk for type 2 diabetes: a randomized trial. JAMA. 2003 Apr 9;289(14):1833-6. doi: 10.1001/jama.289.14.1833.
Results Reference
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PubMed Identifier
18817493
Citation
Trief PM, Sandberg J, Izquierdo R, Morin PC, Shea S, Brittain R, Feldhousen EB, Weinstock RS. Diabetes management assisted by telemedicine: patient perspectives. Telemed J E Health. 2008 Sep;14(7):647-55. doi: 10.1089/tmj.2007.0107.
Results Reference
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Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients

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