Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

Type 1 Diabetes Clinical Trial

— COBOL  

Official title:

Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229097
• Other study ID #: 13 7029 08
• Secondary ID: 2014-000969-4713
• Status: Completed
• Phase: Phase 4
• First received: August 26, 2014
• Last updated: February 21, 2017
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Normal bolus
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
• Coordinated bolus
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.

Locations

Country	Name	City	State
France	Saint-André Hospital	Bordeaux
France	Lapeyronie Hospital	Montpellier
France	University Hospital Toulouse Rangueil	Toulouse	Haute Garonne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (10)

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

Bondia J, Dassau E, Zisser H, Calm R, Vehí 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. — View Citation

Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf

Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.

Etude Jubilé. SFD 2013

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

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. — View 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. — View 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. — View Citation

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postprandial glycaemia	measured by Self Monitoring of Blood Glucose	2 hours after eating during 4 weeks
Secondary	adverse events		Throughout the study (4 weeks)
Secondary	severe hypoglycaemia frequency		Throughout the study (4 weeks)
Secondary	insulin doses		basal rate and boluses
Secondary	mean glycaemia	data from Self Monitoring of Blood Glucose	before eating and 2 hours after eating during 4 weeks
Secondary	standard deviation of glycaemia	data from Self Monitoring of Blood Glucose	before eating and 2 hours after eating during 4 weeks
Secondary	frequency of glycaemia < or = 60mg/dl	data from Self Monitoring of Blood Glucose	before eating and 2 hours after eating during 4 weeks
Secondary	frequency of glycaemia between 61-140mg/dl	data from Self Monitoring of Blood Glucose	before eating and 2 hours after eating during 4 weeks
Secondary	frequency of glycaemia >140mg/dl	data from Self Monitoring of Blood Glucose	before eating and 2 hours after eating during 4 weeks
Secondary	mean glycemia	data from Continue Glycemia Monitoring	Throughout the day during 4 weeks
Secondary	standard deviation	data from Continue Glycemia Monitoring	Throughout the day during 4 weeks
Secondary	time spent within glucose range < or = 60mg/dl	data from Continue Glycemia Monitoring	Throughout the day during 4 weeks
Secondary	time spent within glucose range between 61-140mg/dl	data from Continue Glycemia Monitoring	Throughout the day during 4 weeks
Secondary	time spent within glucose range mg/dl	data from Continue Glycemia Monitoring	Throughout the day during 4 weeks
Secondary	fructosamine		day 1
Secondary	fructosamine		day 1 + 2 weeks
Secondary	fructosamine		day 1 + 4 weeks