Diabetes type1
Conditions
Keywords
diabetes type 1, insulin pump, prandial insulin requirement, pure protein meal, high protein meal, square bolus, square-wave bolus, insulin bolus, dietary protein
Brief summary
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.
Detailed description
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.
Interventions
DRUGInsulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
DRUGInsulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro 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
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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 * insulin requirement more than 0,5 units/kg/day
Exclusion criteria
* diabetes related complications (e.g. nephropathy) * chronic kidney diseases * 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 | 30 minutes after the meal | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia episodes | 5-hour study period | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms |
| Glucose Area Under the Curve (AUC) | 5-hour study period | Measurements based on CGMS |
| Mean amplitude of glycemic excursion | 5-hour study period | measurements based on SMBG |
| The difference between the maximum and baseline glucose level | 5-hour study period | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) |
Countries
Poland
Contacts
Primary ContactKamila Indulska
Backup ContactKatarzyna Dżygało
Outcome results
None listed