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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Diabetes Type 1

Treatments: Drug: Insulin Aspart

Study type: Interventional

Funder types: Other

Identifiers

NCT02546401

2015-000915-42 (EudraCT Number)

RB 15-027

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Insulin Aspart

Group 2

Experimental group

Description:

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

Treatment:

Drug: Insulin Aspart