Diabetes Type 1
Conditions
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.
Interventions
DRUGInsulin Aspart
Injection of Insulin Aspart before or after meals
Sponsors
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Curve (AUC) of glycemia | 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
| Measure | Time frame |
|---|---|
| Mean Amplitude of Glycemic excursions (MAGE) = measure of glycemia instability | During 14 days |
| Area Under Curve (AUC) during 4H after a high-fat meal | 4 hours |
Countries
France
Outcome results
None listed