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

NCT ID: NCT02546401

Last Updated: 2025-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-03-31

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.

Conditions

Diabetes Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Intervention: drug (insulin Aspart)

Group Type: EXPERIMENTAL

Insulin Aspart

Intervention Type: DRUG

Injection of Insulin Aspart before or after meals

Group 2

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

Intervention: drug (insulin Aspart)

Group Type: EXPERIMENTAL

Insulin Aspart

Intervention Type: DRUG

Injection of Insulin Aspart before or after meals

Interventions

Insulin Aspart

Injection of Insulin Aspart before or after meals

Intervention Type: DRUG

Other Intervention Names

Bolus

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHRU Brest

Brest, , France

Countries

France

References

Thuillier P, Sonnet E, Alavi Z, Roudaut N, Nowak E, Dion A, Kerlan V. Comparison between preprandial vs. postprandial insulin aspart in patients with type 1 diabetes on insulin pump and real-time continuous glucose monitoring. Diabetes Metab Res Rev. 2018 Sep;34(6):e3019. doi: 10.1002/dmrr.3019. Epub 2018 Jun 1.

Reference Type: RESULT

PMID: 29749032 (View on PubMed)

Other Identifiers

2015-000915-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RB 15-027

Identifier Type: -

Identifier Source: org_study_id