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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Medical University
Warsaw, Poland
RECRUITINGPostprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 30 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 60 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 90 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 120 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 150 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 180 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 210 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 240 minutes after the meal
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Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 270 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)
Time frame: 300 minutes after the meal
Hypoglycemia episodes
Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms
Time frame: 5-hour study period
Glucose Area Under the Curve (AUC)
Measurements based on CGMS
Time frame: 5-hour study period
Mean amplitude of glycemic excursion
measurements based on SMBG
Time frame: 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)
Time frame: 5-hour study period