NCT02276859

Normal Versus Dual Wave Insulin Bolus for High-protein Food

The Optimal Type of Bolus Following a High-protein Meal in Type 1 Diabetic Children Treated With Insulin Pumps

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DRUG	insulin aspart	A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
DRUG	insulin lispro	A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
DRUG	insulin glulisine	A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-10-28
• Last updated: 2018-01-31

Locations

1 site across 1 country: Poland