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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Yves Benhamou, Pr | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital, Department of Endocrinology | Grenoble | Auvergne-Rhône-Alpes | 38043 | France | ||
| University Hospital of Caen (Hospital Côte de nacre) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12716807 | Background | 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. | |
| 16249542 | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
| Annual cost of diabetes care from hospital and health insurance' points of view | 12 months |
| 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 |
| Qualitative analysis by semi-structured interviews, then quantitative survey by questionnaire | 12 months |
| Caen |
| Basse-Normandie |
| 14033 |
| France |
| University Hospital of Besancon - Hospital Jean Minjoz | Besançon | Franche Comté | 25030 | 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 Region | 44093 | France |
| University Hospital of Lyon (HCL Lyon sud) | Lyon | Rhônes-Alpes | 69310 | France |
| Hospital Sud Francilien | Corbeil Essonne | Île-de-France Region | 91100 | France |
| 15111526 | 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. |
| 17395516 | 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. |
| 17475533 | 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. |
| 15677779 | 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. |
| 15142919 | 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. |
| 17130195 | 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. |
| 12684363 | 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. |
| 18817493 | 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. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |