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

February 21, 2017 updated by: University Hospital, Toulouse

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

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France, 33000
        • Saint-André Hospital
      • Montpellier, France, 34295
        • Lapeyronie Hospital
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31059
        • University Hospital Toulouse Rangueil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
severe hypoglycaemia frequency
Time Frame: Throughout the study (4 weeks)
Throughout the study (4 weeks)
insulin doses
Time Frame: basal rate and boluses
basal rate and boluses
mean glycaemia
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
standard deviation of glycaemia
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 < or = 60mg/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 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
before eating and 2 hours after eating during 4 weeks
mean glycemia
Time Frame: Throughout the day during 4 weeks
data from Continue Glycemia Monitoring
Throughout the day during 4 weeks
standard deviation
Time Frame: Throughout the day during 4 weeks
data from Continue Glycemia Monitoring
Throughout the day during 4 weeks
time spent within glucose range < or = 60mg/dl
Time Frame: Throughout the day during 4 weeks
data from Continue Glycemia Monitoring
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
Throughout the day during 4 weeks
time spent within glucose range mg/dl
Time Frame: Throughout the day during 4 weeks
data from Continue Glycemia Monitoring
Throughout the day during 4 weeks
fructosamine
Time Frame: day 1
day 1
fructosamine
Time Frame: day 1 + 2 weeks
day 1 + 2 weeks
fructosamine
Time Frame: day 1 + 4 weeks
day 1 + 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vincent Melki, Doctor, University Hospital, Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

August 26, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

August 29, 2014

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

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)?

NO

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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