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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-000969-47 | EudraCT Number | ||
| 13-074 | Other Grant/Funding Number | French Ministry of Health, PHRC 2013 |
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A recent study suggests that, in Type 1 Diabetes (T1D) patients treated by insulin pumps, a better coordination of meal boluses and post prandial basal rate could reduce the importance of postprandial hyperglycaemias without increasing the risk of delayed hypoglycaemias.
The aim of the investigators study is to assess if these results are confirmed in a clinical trial.
The aim of this study is to compare the efficacy of coordinated boluses versus normal boluses on postprandial glycaemic control of T1D patients treated with continuous subcutaneous insulin infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal then Coordinated | Experimental | normal bolus during 2 weeks then coordinated bolus during 2 weeks |
|
| Coordinated then Normal | Experimental | coordinated bolus during 2 weeks then normal bolus during 2 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal bolus | Drug | During the "normal bolus" period, the bolus will be adjusted to the carbohydrate content of each meal and injected immediately. The basal rate will remain at a normal level during the 3 hours postprandial period |
| Measure | Description | Time Frame |
|---|---|---|
| postprandial glycaemia | measured by Self Monitoring of Blood Glucose | 2 hours after eating during 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | Throughout the study (4 weeks) | |
| severe hypoglycaemia frequency | Throughout the study (4 weeks) | |
| insulin doses |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Melki, Doctor | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Toulouse Rangueil | Toulouse | Haute Garonne | 31059 | France | ||
| Saint-André Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20046653 | Background | Bondia J, Dassau E, Zisser H, Calm R, Vehi J, Jovanovic L, Doyle FJ 3rd. Coordinated basal-bolus infusion for tighter postprandial glucose control in insulin pump therapy. J Diabetes Sci Technol. 2009 Jan;3(1):89-97. doi: 10.1177/193229680900300110. | |
| Background | A. Farret, B. Catargi, J.P. Riveline, V. Melki, P. Schaepelynck, A. Sola, B. Guerci, H. Bertet, T. Mura, H. Chevassus, E. Renard : Étude randomisée contrôlée en cross-over comparant les effets sur le contrôle glycémique des bolus immédiats et combinés chez des patients diabétiques de type 1 traités par pompe à insuline portable. Diabetes & Metabolism, Volume 38, Supplement 2, March 2012, Page A6 | ||
| Background | Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010. | ||
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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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| Coordinated bolus | Drug | The basal rate will be reduced at a rate of 0.1 U/h during the 3 h postprandial period. The insulin subtracted of the basal rate will be added to the normal bolus calculated for the meal and injected immediately. |
|
| basal rate and boluses |
| mean glycaemia | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks |
| standard deviation of glycaemia | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks |
| frequency of glycaemia < or = 60mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks |
| frequency of glycaemia between 61-140mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks |
| frequency of glycaemia >140mg/dl | data from Self Monitoring of Blood Glucose | before eating and 2 hours after eating during 4 weeks |
| mean glycemia | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks |
| standard deviation | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks |
| time spent within glucose range < or = 60mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks |
| time spent within glucose range between 61-140mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks |
| time spent within glucose range mg/dl | data from Continue Glycemia Monitoring | Throughout the day during 4 weeks |
| fructosamine | day 1 |
| fructosamine | day 1 + 2 weeks |
| fructosamine | day 1 + 4 weeks |
| Bordeaux |
| 33000 |
| France |
| Lapeyronie Hospital | Montpellier | 34295 | France |
| Background |
| Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401. |
| 16371630 | Background | Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B; Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005 Dec 22;353(25):2643-53. doi: 10.1056/NEJMoa052187. |
| Background | Etude Jubilé. SFD 2013 |
| 11909787 | Background | Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. 2002 Mar 23;324(7339):705. doi: 10.1136/bmj.324.7339.705. |
| 10480516 | Background | Mudaliar SR, Lindberg FA, Joyce M, Beerdsen P, Strange P, Lin A, Henry RR. Insulin aspart (B28 asp-insulin): a fast-acting analog of human insulin: absorption kinetics and action profile compared with regular human insulin in healthy nondiabetic subjects. Diabetes Care. 1999 Sep;22(9):1501-6. doi: 10.2337/diacare.22.9.1501. |
| Background | Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf |
| Background | Melki.v, Cazals.l : Impact de la coordination des bolus et du débit de base sur le contrôle des glycémies postprandiales chez des diabétiques de type 1 traités par pompe externe (étude pilote). Poster accepté SFD 2014 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |