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This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.
Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group A | Placebo Comparator | On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal. The 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 |
|
| group B | Active Comparator | On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal. The 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 glulisine | 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) | 30 minutes after the meal |
| 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 (SMBG) | 90 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 120 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 150 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 180 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 210 minutes after the meal |
| Postprandial glycemia |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia episodes | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms | 5-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 | Role | Phone | Extension | |
|---|---|---|---|---|
| Kamila Indulska | Contact | 48223179421 | ||
| Katarzyna Dżygało | Contact | 48223179538 | k.dzygalo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Katarzyna Dżygało | Department of Pediatrics, Warsaw Medical University | Principal Investigator |
| Kamila Indulska | University of Alberta | Study Director |
| Agnieszka Szypowska |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University | Recruiting | Warsaw | 02- 091 | 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 |
|---|---|
| C479079 | insulin glulisine |
| D061267 | Insulin Aspart |
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Insulin aspart | 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 lispro | Drug | A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial |
|
|
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) |
| 240 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 270 minutes after the meal |
| Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 300 minutes after the meal |
| 5-hour study period |
| Mean amplitude of glycemic excursion | measurements based on SMBG | 5-hour study period |
| The difference between the maximum and baseline glucose level | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 5-hour study period |
| University of Alberta |
| Study Chair |
| 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 |