Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design

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


Related Conditions & MeSH terms


NCT number NCT02546401
Study type Interventional
Source University Hospital, Brest
Contact Emmanuel Sonnet, Dr
Phone 33298347119
Email emmanuel.sonnet@chu-brest.fr
Status Recruiting
Phase Phase 3
Start date September 2015
Completion date June 2016

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT06207838 - Transition of T1DM Patients Aged Over 65 Years Into AHCL (780G) Insulin Pump N/A
Withdrawn NCT02057497 - An Exploratory Clinical Trial to Generate Whole Blood Samples for Analysing Genetic Polymorphisms N/A
Active, not recruiting NCT05088616 - Native American Diabetes Project N/A
Withdrawn NCT01501032 - Inpatient Evaluation of the MD-Logic Artificial Pancreas System in Patients With Type 1 Diabetes Phase 1
Completed NCT01770561 - Feasibility Study of an Integrated Sensor and Infusion Set N/A
Completed NCT00417131 - Imaging of Islet Transplantation With PET and MRT N/A
Completed NCT03538106 - Factors Associated With Cesarean Delivery in Women With Type 1 Diabetes
Completed NCT01565824 - Web-based Support During Pregnancy and Early Motherhood in Women With Type 1 Diabetes (MODIAB-web) N/A
Recruiting NCT04257877 - Proteomic Analysis in Paediatric Diabetes Type 1 (PAPD)
Withdrawn NCT01322321 - ACZ885 in Type 1 Diabetes Mellitus Phase 2
Active, not recruiting NCT04794283 - Antenatal Hand Milking for Pregnant Women With Diabetes'
Completed NCT03842683 - CGM Precision and Glycaemic Variability
Enrolling by invitation NCT04874532 - A Study to Improve Diabetes Management Among Adults Experiencing Severe Hypoglycemia N/A
Terminated NCT00925977 - Treatment Satisfaction of Insulin Glargine Plus Insulin Apidra Compared With NPH Insulin Plus Insulin Apidra in Recently Diagnosed Type 1 Diabetes Children and Adolescents N/A
Completed NCT02066350 - Cardiovascular Risk Factors After Single Pancreas Transplantation N/A
Completed NCT02137174 - Home and School Visits Intervention for Children With DM TYPE 1 Phase 2/Phase 3
Completed NCT06365255 - National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
Completed NCT03433677 - A Study of LY900014 and Insulin Lispro With an External Continuous Subcutaneous Insulin Infusion System in Adult Participants With Type 1 Diabetes Phase 3
Completed NCT04587297 - Food Collection From Type 1 Diabetic Patients Practicing Insulin Functional Therapy
Completed NCT02490124 - The Effect of Type 1 Diabetes on Pan-Arterial Vascular Function and Insulin Sensitivity in Humans N/A