Clinical trial NCT01447940: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
Official title: Prospective Assessment of Meos Telemedicine E-portal on Ambulatory Care of Type 1 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 1
Keywords: Telemedicine
Type 1 diabetes
economic cost of Type 1 diabetes
ePortal Meos
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2011-10-06
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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)

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: HbA1c measured at 6 months in each group
timeFrame: 6 months
measure: HbA1c measured at 12 months in each group
timeFrame: 12 months
measure: HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)
timeFrame: 6 months
measure: HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)
timeFrame: 12 months
measure: Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up
timeFrame: 12 months
measure: Annual cost of diabetes care from hospital and health insurance' points of view
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire
timeFrame: 12 months
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital of Caen (Hospital Côte de nacre)
state: Basse-Normandie
city: Besancon
country: France
facility: University Hospital of Besancon - Hospital Jean Minjoz
state: Franche Comté
city: Corbeil Essonne
country: France
facility: Hospital Sud Francilien
state: Ile de France
city: Montpellier
country: France
facility: Hospital University of Montpellier
state: Languedoc-Roussillon
city: Reims
country: France
facility: University Hospital of Reims
state: Marne
city: Nantes
country: France
facility: University Hospital of Nantes
state: Pays-de-la-Loire
city: Grenoble
country: France
facility: University Hospital, Department of Endocrinology
state: Rhône-Alpes
city: Lyon
country: France
facility: University Hospital of Lyon (HCL Lyon sud)
state: Rhônes-Alpes
Study officials:
affiliation: University Hospital, Grenoble
name: Pierre-Yves Benhamou, Pr
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.