- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229097
Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients (COBOL)
Clinical Efficacy of Coordinated Boluses in Type 1 Diabetic Patients Treated With Insulin Pumps: a Multicentric, Randomised, Cross Over Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33000
- Saint-André Hospital
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Montpellier, France, 34295
- Lapeyronie Hospital
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Haute Garonne
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Toulouse, Haute Garonne, France, 31059
- University Hospital Toulouse Rangueil
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Normal then Coordinated
normal bolus during 2 weeks then coordinated bolus during 2 weeks
|
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
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.
|
Experimental: Coordinated then Normal
coordinated bolus during 2 weeks then normal bolus during 2 weeks
|
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postprandial glycaemia
Time Frame: 2 hours after eating during 4 weeks
|
measured by Self Monitoring of Blood Glucose
|
2 hours after eating during 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: Throughout the study (4 weeks)
|
Throughout the study (4 weeks)
|
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severe hypoglycaemia frequency
Time Frame: Throughout the study (4 weeks)
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Throughout the study (4 weeks)
|
|
insulin doses
Time Frame: basal rate and boluses
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basal rate and boluses
|
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mean glycaemia
Time Frame: before eating and 2 hours after eating during 4 weeks
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data from Self Monitoring of Blood Glucose
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before eating and 2 hours after eating during 4 weeks
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standard deviation of glycaemia
Time Frame: before eating and 2 hours after eating during 4 weeks
|
data from Self Monitoring of Blood Glucose
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before eating and 2 hours after eating during 4 weeks
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frequency of glycaemia < or = 60mg/dl
Time Frame: before eating and 2 hours after eating during 4 weeks
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data from Self Monitoring of Blood Glucose
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before eating and 2 hours after eating during 4 weeks
|
frequency of glycaemia between 61-140mg/dl
Time Frame: before eating and 2 hours after eating during 4 weeks
|
data from Self Monitoring of Blood Glucose
|
before eating and 2 hours after eating during 4 weeks
|
frequency of glycaemia >140mg/dl
Time Frame: before eating and 2 hours after eating during 4 weeks
|
data from Self Monitoring of Blood Glucose
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before eating and 2 hours after eating during 4 weeks
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mean glycemia
Time Frame: Throughout the day during 4 weeks
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data from Continue Glycemia Monitoring
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Throughout the day during 4 weeks
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standard deviation
Time Frame: Throughout the day during 4 weeks
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data from Continue Glycemia Monitoring
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Throughout the day during 4 weeks
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time spent within glucose range < or = 60mg/dl
Time Frame: Throughout the day during 4 weeks
|
data from Continue Glycemia Monitoring
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Throughout the day during 4 weeks
|
time spent within glucose range between 61-140mg/dl
Time Frame: Throughout the day during 4 weeks
|
data from Continue Glycemia Monitoring
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Throughout the day during 4 weeks
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time spent within glucose range mg/dl
Time Frame: Throughout the day during 4 weeks
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data from Continue Glycemia Monitoring
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Throughout the day during 4 weeks
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fructosamine
Time Frame: day 1
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day 1
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fructosamine
Time Frame: day 1 + 2 weeks
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day 1 + 2 weeks
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fructosamine
Time Frame: day 1 + 4 weeks
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day 1 + 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Vincent Melki, Doctor, University Hospital, Toulouse
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13 7029 08
- 13-074 (French Ministry of Health, PHRC 2013)
- 2014-000969-47 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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