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Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump (BOLUS)

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ClinicalTrials.gov Identifier: NCT02546401
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Tracking Information
First Submitted Date  ICMJE September 9, 2015
First Posted Date  ICMJE September 10, 2015
Last Update Posted Date April 22, 2016
Study Start Date  ICMJE September 2015
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
Area Under Curve (AUC) of glycemia [ Time Frame: During 14 days ]
Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
AUC of glycemia [ Time Frame: During 14 days ]
AUC recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
Change History Complete list of historical versions of study NCT02546401 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability [ Time Frame: During 14 days ]
  • Area Under Curve (AUC) during 4H after a high-fat meal [ Time Frame: 4 hours ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2015)
  • MAGE = measure of glycemia instability [ Time Frame: During 14 days ]
  • AUC during 4H after a high-fat meal [ Time Frame: 4 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
Official Title  ICMJE Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.
Brief Summary The current study focuses on terms of use of Insulin Aspart, fast analogue of human insulin and commonly used in the treatment of type 1 diabetes, where it obtained the marketing authorization for this indication. In the patient who have an insulin pump, insulin Aspart is given daily like a pre-prandial bolus (just before the meal). However, many patients perform their bolus after the meal. However this insulin administration modality is not clearly studied in the literature.
Detailed Description

The functional insulin therapy is a method for adjusting insulin doses which tends to mimic the physiology, especially when food intake with proportional dose calculation to the amount of carbohydrates ingested by the use of ratios. This method of adaptation, increasingly used in France, is an extension in the use of subcutaneous insulin pump with a more precise determination of bolus doses with meals, and use of aids dose calculations (assistant wizard for instance). In practice every day, some patients perform their bolus immediately after eating, not just before, allowing them to know exactly the amount of ingested carbohydrates and not the one provided in advance.

This study is very interesting because it allows to compare the injection of an analogous bolus of fast insulin before and after the meal.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Type 1
Intervention  ICMJE Drug: Insulin Aspart
Injection of Insulin Aspart before or after meals
Other Name: Bolus
Study Arms  ICMJE
  • Experimental: Group 1

    Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF).

    Intervention: drug (insulin Aspart)

    Intervention: Drug: Insulin Aspart
  • Experimental: Group 2

    Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE).

    Intervention: drug (insulin Aspart)

    Intervention: Drug: Insulin Aspart
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2015)
22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Major patients with type 1 diabetes treated with insulin pump.

Exclusion Criteria:

  • Unbalanced diabetes,
  • Ongoing pregnancy known,
  • Gastrointestinal neuropathy known,
  • Chronic medical illness and psychiatric
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02546401
Other Study ID Numbers  ICMJE RB 15-027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Brest
Study Sponsor  ICMJE University Hospital, Brest
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Brest
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP