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

Diabetes Type 1 Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02546401
• Other study ID #: RB 15-027
• Status: Recruiting
• Phase: Phase 3
• First received: September 9, 2015
• Last updated: January 13, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: University Hospital, Brest
• Contact: Emmanuel Sonnet, Dr
• Phone: 33298347119
• Email: emmanuel.sonnet[@]chu-brest.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 22
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Diabetes Type 1

Intervention

Drug:
• Insulin Aspart
Injection of Insulin Aspart before or after meals

Locations

Country	Name	City	State
France	CHRU Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	During 14 days	No
Secondary	Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability		During 14 days	No
Secondary	Area Under Curve (AUC) during 4H after a high-fat meal		4 hours	No