Clinical trial NCT02685449: Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.
Official title: Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes type1
Keywords: diabetes type 1
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 70
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postprandial glycemia
timeFrame: 30 minutes after the meal
measure: Postprandial glycemia
timeFrame: 60 minutes after the meal
measure: Postprandial glycemia
timeFrame: 90 minutes after the meal
measure: Postprandial glycemia
timeFrame: 120 minutes after the meal
measure: Postprandial glycemia
timeFrame: 150 minutes after the meal
measure: Postprandial glycemia
timeFrame: 180 minutes after the meal
measure: Postprandial glycemia
timeFrame: 210 minutes after the meal
measure: Postprandial glycemia
timeFrame: 240 minutes after the meal
measure: Postprandial glycemia
timeFrame: 270 minutes after the meal
measure: Postprandial glycemia
timeFrame: 300 minutes after the meal
Secondary outcomes:
measure: Hypoglycemia episodes
timeFrame: 5-hour study period
measure: Glucose Area Under the Curve (AUC)
timeFrame: 5-hour study period
measure: Mean amplitude of glycemic excursion
timeFrame: 5-hour study period
measure: The difference between the maximum and baseline glucose level
timeFrame: 5-hour study period
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University
Study officials:
affiliation: Department of Pediatrics, Warsaw Medical University
name: Katarzyna Dżygało
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Kamila Indulska
role: STUDY_DIRECTOR
affiliation: University of Alberta
name: Agnieszka Szypowska
role: STUDY_CHAIR
References: