Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1007 for:    Area Under Curve AND insulin
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02546401
Recruitment Status : Completed
First Posted : September 10, 2015
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Type 1 Drug: Insulin Aspart Phase 3

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : September 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1

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

Intervention: drug (insulin Aspart)

Drug: Insulin Aspart
Injection of Insulin Aspart before or after meals
Other Name: Bolus

Experimental: Group 2

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

Intervention: drug (insulin Aspart)

Drug: Insulin Aspart
Injection of Insulin Aspart before or after meals
Other Name: Bolus




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02546401


Locations
Layout table for location information
France
CHRU Brest
Brest, France, 29200
Sponsors and Collaborators
University Hospital, Brest

Layout table for additonal information
Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02546401     History of Changes
Other Study ID Numbers: RB 15-027
First Posted: September 10, 2015    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs