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

NCT ID: NCT01447940

Last Updated: 2014-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 1

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Conventional Care

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

Group Type PLACEBO_COMPARATOR

Meos ePortal use

Intervention Type DEVICE

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

Meos ePortal use

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

Group Type EXPERIMENTAL

Meos ePortal use

Intervention Type DEVICE

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

Interventions

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Meos ePortal use

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

Intervention Type DEVICE

Other Intervention Names

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Telemedicine ePortal

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre-Yves Benhamou, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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University Hospital, Department of Endocrinology

Grenoble, Auvergne-Rhône-Alpes, France

Site Status

University Hospital of Caen (Hospital Côte de nacre)

Caen, Basse-Normandie, France

Site Status

University Hospital of Besancon - Hospital Jean Minjoz

Besançon, Franche Comté, France

Site Status

Hospital University of Montpellier

Montpellier, Languedoc-Roussillon, France

Site Status

University Hospital of Reims

Reims, Marne, France

Site Status

University Hospital of Nantes

Nantes, Pays de la Loire Region, France

Site Status

University Hospital of Lyon (HCL Lyon sud)

Lyon, Rhônes-Alpes, France

Site Status

Hospital Sud Francilien

Corbeil Essonne, Île-de-France Region, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 12716807 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16249542 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15111526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17395516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17475533 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15677779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15142919 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17130195 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12684363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18817493 (View on PubMed)

Other Identifiers

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DCIC10 20

Identifier Type: -

Identifier Source: org_study_id