Type 1 Diabetes
Conditions
Keywords
dual-wave bolus, square bolus, normal bolus, standard bolus, high-protein meal, prandial insulin requirement
Brief summary
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.
Detailed description
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.
Interventions
DRUGinsulin aspart
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
DRUGinsulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
DRUGinsulin glulisine
A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* duration of type 1 diabetes longer than 12 months * insulin pump therapy longer than 3 months * written informed consent by patients and parents * patients must be willing to wear a glucose sensor for two days * insulin requirement more than 0,5 units/kg/day
Exclusion criteria
* concomitant dietary restrictions (e.g. celiac disease or food allergy) * diabetes related complications (e.g. nephropathy) * any disease judged by the investigator to affect the trial * withdrawal of consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial glycemia | 60 minutes after the meal | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia episodes | 3-hour study period | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms |
| Glucose Area Under the Curve (AUC) | 3-hour study period | measurements based on CGMS |
| Mean amplitude of glycemic excursion | 3-hour study period | measurements based on CGMS |
Countries
Poland
Outcome results
None listed