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

Phase 3

Completed

• Conditions: Diabetes Type 1
• Interventions: Drug: Insulin Aspart

• Registration Number: NCT02546401
• Lead Sponsor: University Hospital, Brest

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-09
• Study First Submitted QC: 2015-09-09
• Study First Posted: 2015-09-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	Insulin Aspart	Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF). Intervention: drug (insulin Aspart)
Group 2	Insulin Aspart	Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE). Intervention: drug (insulin Aspart)

Primary Outcome Measures

Name	Time	Method
Area Under Curve (AUC) of glycemia	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)

Secondary Outcome Measures

Name	Time	Method
Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability	During 14 days
Area Under Curve (AUC) during 4H after a high-fat meal	4 hours

Trial Locations

Locations (1)

CHRU Brest; 🇫🇷 Brest, France