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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000915-42 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Patients will perform their bolus for 2 weeks before meals (BE) and for 2 weeks after meals (AF). Intervention: drug (insulin Aspart) |
|
| Group 2 | Experimental | Patients will perform their bolus for 2 weeks after meals (AF) and for 2 weeks before meals (BE). Intervention: drug (insulin Aspart) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Aspart | Drug | Injection of Insulin Aspart before or after meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of glycemia | Area Under Curve (AUC) recording blood glucose performed continuously over 14 days, with baseline to 1,40g/L (in order not to consider hypoglycemia) | During 14 days |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU Brest | Brest | 29200 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29749032 | Result | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| C073681 | NOP-bolus regimen |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |