Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump (BOLUS)
Primary Purpose
Diabetes Type 1
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Insulin Aspart
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Type 1
Eligibility Criteria
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
Sites / Locations
- CHRU Brest
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1
Group 2
Arm Description
Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF). Intervention: drug (insulin Aspart)
Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE). Intervention: drug (insulin Aspart)
Outcomes
Primary Outcome Measures
Area Under Curve (AUC) of glycemia
Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
Secondary Outcome Measures
Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability
Area Under Curve (AUC) during 4H after a high-fat meal
Full Information
NCT ID
NCT02546401
First Posted
September 9, 2015
Last Updated
April 21, 2016
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT02546401
Brief Title
Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
Acronym
BOLUS
Official Title
Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Type 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Experimental
Arm Description
Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF).
Intervention: drug (insulin Aspart)
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE).
Intervention: drug (insulin Aspart)
Intervention Type
Drug
Intervention Name(s)
Insulin Aspart
Other Intervention Name(s)
Bolus
Intervention Description
Injection of Insulin Aspart before or after meals
Primary Outcome Measure Information:
Title
Area Under Curve (AUC) of glycemia
Description
Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia)
Time Frame
During 14 days
Secondary Outcome Measure Information:
Title
Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability
Time Frame
During 14 days
Title
Area Under Curve (AUC) during 4H after a high-fat meal
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHRU Brest
City
Brest
ZIP/Postal Code
29200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Insulin's Injection Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump
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