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

Diabetes Mellitus, Type 1 Clinical Trial

— TELEDIAB-3  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01447940
• Other study ID #: DCIC10 20
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 3, 2011
• Last updated: December 8, 2014
• Start date: January 2012
• Est. completion date: December 2015

Study information

• Verified date: December 2014
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 720
• Est. completion date: December 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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

Locations

Country	Name	City	State
France	University Hospital of Besancon - Hospital Jean Minjoz	Besancon	Franche Comté
France	University Hospital of Caen (Hospital Côte de nacre)	Caen	Basse-Normandie
France	Hospital Sud Francilien	Corbeil Essonne	Ile de France
France	University Hospital, Department of Endocrinology	Grenoble	Rhône-Alpes
France	University Hospital of Lyon (HCL Lyon sud)	Lyon	Rhônes-Alpes
France	Hospital University of Montpellier	Montpellier	Languedoc-Roussillon
France	University Hospital of Nantes	Nantes	Pays-de-la-Loire
France	University Hospital of Reims	Reims	Marne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (10)

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. — View 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. Epub 2007 May 1. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months	No
Secondary	HbA1c measured at 6 months in each group		6 months	No
Secondary	HbA1c measured at 12 months in each group		12 months	No
Secondary	HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)		6 months	No
Secondary	HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)		12 months	No
Secondary	Definition of failure: study withdraws or emergency hospitalization linked to diabetes or HbA1c increase of 0.5 % up to 12 months of follow up		12 months	Yes
Secondary	Annual cost of diabetes care from hospital and health insurance' points of view		12 months	No
Secondary	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		12 months	No
Secondary	Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire		12 months	No