Clinical trial NCT02229097: Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients
Official title: Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2014-08-29
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* with confirmed Negative C-peptide or diabetes duration\>5 years
* Treated by external insulin pump and rapid insulin analog for more than 3 months
* using a Medtronic Paradigm Real-Time or Veo™ model
* Educated to and practicing functional insulin treatment and carbohydrate counting for more than 3 months
* Able to use the "basal temp" and "glycaemia reminder" functions of their pump
* Basal infusion rate ≥ 0,5 Unit/h
* Self-monitoring of blood glucose frequency \> 4/days
* Aware of hypoglycaemia

Exclusion Criteria:

* known impaired renal function (creatinin clearance \<60ml/min)
* Gastroparesis
* Serious or instable disease likely to induce a glycaemic control deterioration - treatment with corticosteroids

Primary outcomes:
measure: postprandial glycaemia
timeFrame: 2 hours after eating during 4 weeks
Secondary outcomes:
measure: adverse events
timeFrame: Throughout the study (4 weeks)
measure: severe hypoglycaemia frequency
timeFrame: Throughout the study (4 weeks)
measure: insulin doses
timeFrame: basal rate and boluses
measure: mean glycaemia
timeFrame: before eating and 2 hours after eating during 4 weeks
measure: standard deviation of glycaemia
timeFrame: before eating and 2 hours after eating during 4 weeks
measure: frequency of glycaemia < or = 60mg/dl
timeFrame: before eating and 2 hours after eating during 4 weeks
measure: frequency of glycaemia between 61-140mg/dl
timeFrame: before eating and 2 hours after eating during 4 weeks
measure: frequency of glycaemia >140mg/dl
timeFrame: before eating and 2 hours after eating during 4 weeks
measure: mean glycemia
timeFrame: Throughout the day during 4 weeks
measure: standard deviation
timeFrame: Throughout the day during 4 weeks
measure: time spent within glucose range < or = 60mg/dl
timeFrame: Throughout the day during 4 weeks
measure: time spent within glucose range between 61-140mg/dl
timeFrame: Throughout the day during 4 weeks
measure: time spent within glucose range mg/dl
timeFrame: Throughout the day during 4 weeks
measure: fructosamine
timeFrame: day 1
measure: fructosamine
timeFrame: day 1 + 2 weeks
measure: fructosamine
timeFrame: day 1 + 4 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse Rangueil
state: Haute Garonne
city: Bordeaux
country: France
facility: Saint-André Hospital
city: Montpellier
country: France
facility: Lapeyronie Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Vincent Melki, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.
citation: 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.
citation: 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.
citation: Etude Jubilé. SFD 2013
citation: 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.
citation: 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.
citation: Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf
citation: 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