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Completed

NCT Number: NCT02546401

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

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.

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Key information

Conditions

Diabetes Type 1 Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHRU Brest

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin aspart

Drug

Injection of Insulin Aspart before or after meals

Other names: Bolus

Primary outcomes

  1. Area Under Curve (AUC) of glycemia

    Time frame: 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 outcomes

  1. Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability

    Time frame: During 14 days

  2. Area Under Curve (AUC) during 4H after a high-fat meal

    Time frame: 4 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Comparison of Injection of an Analogue Bolus of Insulin Before or After the Meal in Type 1 Diabetic Patients Treated With Insulin Pump.

Acronym: BOLUS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2015
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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