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

NCT01447940 | Unknown Phase 3 DMC

• 1 other identifier: DCIC10 20
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 8

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Telemedicine; Type 1 diabetes; economic cost of Type 1 diabetes; ePortal Meos

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• HbA1c measured at 6 months in each group

  6 months

• HbA1c measured at 12 months in each group

  12 months

• HbA1c measured at 6 months in each group according to initial HbA1c level (higher than 8% or to median)

  6 months

• HbA1c measured at 12 months in each group according to initial HbA1c level (higher than 8% or to median)

  12 months

• 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

Study Arms (2)

Conventional Care

PLACEBO COMPARATOR

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

Device: Meos ePortal use

Meos ePortal use

EXPERIMENTAL

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

Device: Meos ePortal use

Interventions

Meos ePortal use DEVICE

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

Also known as: Telemedicine, ePortal

Conventional Care; Meos ePortal use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (8)

University Hospital, Department of Endocrinology

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

University Hospital of Caen (Hospital Côte de nacre)

Caen, Basse-Normandie, 14033, France

Location

University Hospital of Besancon - Hospital Jean Minjoz

Besançon, Franche Comté, 25030, France

Location

Hospital University of Montpellier

Montpellier, Languedoc-Roussillon, 34295, France

Location

University Hospital of Reims

Reims, Marne, 51110, France

Location

University Hospital of Nantes

Nantes, Pays de la Loire Region, 44093, France

Location

University Hospital of Lyon (HCL Lyon sud)

Lyon, Rhônes-Alpes, 69310, France

Location

Hospital Sud Francilien

Corbeil Essonne, Île-de-France Region, 91100, France

Location

Related Publications (10)

• 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.

  PMID: 12716807 BACKGROUND

• 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.

  PMID: 16249542 BACKGROUND

• 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.

  PMID: 15111526 BACKGROUND

• 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.

  PMID: 17395516 BACKGROUND

• 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.

  PMID: 17475533 BACKGROUND

• 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.

  PMID: 15677779 BACKGROUND

• 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.

  PMID: 15142919 BACKGROUND

• 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.

  PMID: 17130195 BACKGROUND

• 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.

  PMID: 12684363 BACKGROUND

• 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.

  PMID: 18817493 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pierre-Yves Benhamou, Pr

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2011
• First Posted: October 6, 2011
• Study Start: January 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

FR (8)