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Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients (COBOL)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Normal bolus
Coordinated bolus
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Toulouse Rangueil
  • Saint-André Hospital
  • Lapeyronie Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal then Coordinated

Coordinated then Normal

Arm Description

normal bolus during 2 weeks then coordinated bolus during 2 weeks

coordinated bolus during 2 weeks then normal bolus during 2 weeks

Outcomes

Primary Outcome Measures

postprandial glycaemia
measured by Self Monitoring of Blood Glucose

Secondary Outcome Measures

adverse events
severe hypoglycaemia frequency
insulin doses
mean glycaemia
data from Self Monitoring of Blood Glucose
standard deviation of glycaemia
data from Self Monitoring of Blood Glucose
frequency of glycaemia < or = 60mg/dl
data from Self Monitoring of Blood Glucose
frequency of glycaemia between 61-140mg/dl
data from Self Monitoring of Blood Glucose
frequency of glycaemia >140mg/dl
data from Self Monitoring of Blood Glucose
mean glycemia
data from Continue Glycemia Monitoring
standard deviation
data from Continue Glycemia Monitoring
time spent within glucose range < or = 60mg/dl
data from Continue Glycemia Monitoring
time spent within glucose range between 61-140mg/dl
data from Continue Glycemia Monitoring
time spent within glucose range mg/dl
data from Continue Glycemia Monitoring
fructosamine
fructosamine
fructosamine

Full Information

First Posted
August 26, 2014
Last Updated
February 21, 2017
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT02229097
Brief Title
Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients
Acronym
COBOL
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

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal then Coordinated
Arm Type
Experimental
Arm Description
normal bolus during 2 weeks then coordinated bolus during 2 weeks
Arm Title
Coordinated then Normal
Arm Type
Experimental
Arm Description
coordinated bolus during 2 weeks then normal bolus during 2 weeks
Intervention Type
Drug
Intervention Name(s)
Normal bolus
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Coordinated bolus
Intervention Description
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.
Primary Outcome Measure Information:
Title
postprandial glycaemia
Description
measured by Self Monitoring of Blood Glucose
Time Frame
2 hours after eating during 4 weeks
Secondary Outcome Measure Information:
Title
adverse events
Time Frame
Throughout the study (4 weeks)
Title
severe hypoglycaemia frequency
Time Frame
Throughout the study (4 weeks)
Title
insulin doses
Time Frame
basal rate and boluses
Title
mean glycaemia
Description
data from Self Monitoring of Blood Glucose
Time Frame
before eating and 2 hours after eating during 4 weeks
Title
standard deviation of glycaemia
Description
data from Self Monitoring of Blood Glucose
Time Frame
before eating and 2 hours after eating during 4 weeks
Title
frequency of glycaemia < or = 60mg/dl
Description
data from Self Monitoring of Blood Glucose
Time Frame
before eating and 2 hours after eating during 4 weeks
Title
frequency of glycaemia between 61-140mg/dl
Description
data from Self Monitoring of Blood Glucose
Time Frame
before eating and 2 hours after eating during 4 weeks
Title
frequency of glycaemia >140mg/dl
Description
data from Self Monitoring of Blood Glucose
Time Frame
before eating and 2 hours after eating during 4 weeks
Title
mean glycemia
Description
data from Continue Glycemia Monitoring
Time Frame
Throughout the day during 4 weeks
Title
standard deviation
Description
data from Continue Glycemia Monitoring
Time Frame
Throughout the day during 4 weeks
Title
time spent within glucose range < or = 60mg/dl
Description
data from Continue Glycemia Monitoring
Time Frame
Throughout the day during 4 weeks
Title
time spent within glucose range between 61-140mg/dl
Description
data from Continue Glycemia Monitoring
Time Frame
Throughout the day during 4 weeks
Title
time spent within glucose range mg/dl
Description
data from Continue Glycemia Monitoring
Time Frame
Throughout the day during 4 weeks
Title
fructosamine
Time Frame
day 1
Title
fructosamine
Time Frame
day 1 + 2 weeks
Title
fructosamine
Time Frame
day 1 + 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Melki, Doctor
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Toulouse Rangueil
City
Toulouse
State/Province
Haute Garonne
ZIP/Postal Code
31059
Country
France
Facility Name
Saint-André Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Lapeyronie Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20046653
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.
Results Reference
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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
Results Reference
background
Citation
Druet C, Roudier C, Romon I, Assogba F, Bourdel-Marchasson I, et al. Échantillon national témoin représentatif des personnes diabétiques, Entred 2007-2010.
Results Reference
background
PubMed Identifier
8366922
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.
Results Reference
background
PubMed Identifier
16371630
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.
Results Reference
background
Citation
Etude Jubilé. SFD 2013
Results Reference
background
PubMed Identifier
11909787
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.
Results Reference
background
PubMed Identifier
10480516
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.
Results Reference
background
Citation
Directive pour la gestion de la glycémie post prandiale, IDF 2007 http://www.idf.org/webdata/docs/French_GMPG Final 110108.pdf
Results Reference
background
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
Results Reference
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Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients

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