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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: insulin aspart; Drug: insulin lispro; Drug: insulin glulisine

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-184
    • Department of Pediatrics, Medical University of Warsaw, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal/ Dual-wave; On the first study day, pre-breakfast insulin was given as a normal bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a dual-wave bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine	Drug: insulin aspart; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Names: NovoRapid®; Drug: insulin lispro; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial; Other Names: Humalog®; Drug: insulin glulisine; A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial; Other Names: Apidra®
Experimental: Dual-wave/Normal; On the first study day, pre-breakfast insulin was given as a dual-wave bolus 15 minutes before a standardized high-protein meal. On the second day, pre-breakfast insulin was given as a normal bolus before the same high-protein meal. The carbo-insulin and fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial. Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine	Drug: insulin aspart; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Names: NovoRapid®; Drug: insulin lispro; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial; Other Names: Humalog®; Drug: insulin glulisine; A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial; Other Names: Apidra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	60 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose	120 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose	180 minutes after the meal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia episodes	Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms	3-hour study period
Glucose Area Under the Curve (AUC)	measurements based on CGMS	3-hour study period
Mean amplitude of glycemic excursion	measurements based on CGMS	3-hour study period

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Study Chair: Agnieszka Szypowska, University of Alberta; Principal Investigator: Katarzyna Piechowiak, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: October 7, 2014
• First Submitted That Met QC Criteria: October 24, 2014
• First Posted (Estimate): October 28, 2014

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: prandial insulin requirement; square bolus; dual-wave bolus; normal bolus; standard bolus; high-protein meal
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
• Other Study ID Numbers: Protein Food Insulin Bolus