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

Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 1

Intervention: Meos ePortal use (Device)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: University Hospital, Grenoble

Official(s) and/or principal investigator(s):
Pierre-Yves Benhamou, Pr, Principal Investigator, Affiliation: University Hospital, Grenoble

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.

Clinical Details

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

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

Primary outcome: 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:

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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)

Locations and Contacts

University Hospital of Caen (Hospital Côte de nacre), Caen, Basse-Normandie 14033, France

University Hospital of Besancon - Hospital Jean Minjoz, Besancon, Franche Comté 25030, France

Hospital Sud Francilien, Corbeil Essonne, Ile de France 91100, France

Hospital University of Montpellier, Montpellier, Languedoc-Roussillon 34295, France

University Hospital of Reims, Reims, Marne 51110, France

University Hospital of Nantes, Nantes, Pays-de-la-Loire 44093, France

University Hospital, Department of Endocrinology, Grenoble, Rhône-Alpes 38043, France

University Hospital of Lyon (HCL Lyon sud), Lyon, Rhônes-Alpes 69310, France

Additional Information

Related publications:

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.

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.

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.

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. Epub 2007 Mar 28.

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. Epub 2007 May 1.

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.

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.

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.

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.

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.

Starting date: January 2012
Last updated: December 8, 2014

Page last updated: August 20, 2015

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