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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
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 glulisine if participant used insulin glulisine before entering the trial
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, Poland
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
Time frame: 120 minutes after the meal
Postprandial glycemia
Post-prandial blood glucose excursions measured by self monitoring of blood glucose
Time frame: 180 minutes after the meal
Hypoglycemia episodes
Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms
Time frame: 3-hour study period
Glucose Area Under the Curve (AUC)
measurements based on CGMS
Time frame: 3-hour study period
Mean amplitude of glycemic excursion
measurements based on CGMS
Time frame: 3-hour study period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.