Clinical trial NCT02276859: Normal Versus Dual Wave Insulin Bolus for High-protein Food
Official title: The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: dual-wave bolus
square bolus
normal bolus
standard bolus
high-protein meal
prandial insulin requirement
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2014-10-28
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: 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.

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
* 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

Primary outcomes:
measure: Postprandial glycemia
timeFrame: 60 minutes after the meal
measure: Postprandial glycemia
timeFrame: 120 minutes after the meal
measure: Postprandial glycemia
timeFrame: 180 minutes after the meal
Secondary outcomes:
measure: Hypoglycemia episodes
timeFrame: 3-hour study period
measure: Glucose Area Under the Curve (AUC)
timeFrame: 3-hour study period
measure: Mean amplitude of glycemic excursion
timeFrame: 3-hour study period
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Pediatrics, Medical University of Warsaw, Poland
Study officials:
affiliation: University of Alberta
name: Agnieszka Szypowska
role: STUDY_CHAIR
affiliation: University of Alberta
name: Katarzyna Piechowiak
role: PRINCIPAL_INVESTIGATOR
References: