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Patients receive a standardized high-protein test meal at breakfast time. Insulin is given as bolus (normal or dual-wave (normal plus square) and basal rate using an insulin pump. The 3h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 1 hour) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
The dual-wave bolus delivers an immediate normal pre-meal insulin bolus followed by square-wave bolus that is evenly delivered over several hours as programmed by the patient. The aim of this study is to compare post-prandial glycaemic excursions following a high-protein meal after administration of insulin by normal vs dual-wave bolus. During this prospective, cross-over, repeated measures study, pediatric patients with type 1 diabetes, treated with insulin pump therapy will be evaluated using the self-blood glucose measurements following standardized high-protein meal and two types of boluses (normal or dual-wave). The required insulin dose will be calculated based on patient's insulin-exchange ratio. A high-protein meal will be given on two subsequent breakfasts and comparisons will be made between normal and dual-wave insulin bolus delivery. Prolonged post-prandial glycaemic excursions will be identified using the CGMS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal/ Dual-wave | Experimental | On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine |
|
| Dual-wave/Normal | Experimental | On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| insulin aspart | Drug | A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 60 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose | 120 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose | 180 minutes after the meal |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia episodes | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms | 3-hour study period |
| Glucose Area Under the Curve (AUC) | measurements based on CGMS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnieszka Szypowska | University of Alberta | Study Chair |
| Katarzyna Piechowiak | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Medical University of Warsaw, Poland | Warsaw | 01-184 | Poland |
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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 |
| D061268 | Insulin Lispro |
| C479079 | insulin glulisine |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| insulin lispro | Drug | A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial |
|
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| insulin glulisine | Drug | A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial |
|
|
| 3-hour study period |
| Mean amplitude of glycemic excursion | measurements based on CGMS | 3-hour study period |
| 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 |