Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.

Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes type1
• Intervention / Treatment: Drug: Insulin glulisine; Drug: Insulin aspart; Drug: Insulin lispro

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.

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

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02- 091
    • Recruiting
    • Medical University
    • Contact: Agnieszka Szypowska, MD, PhD; Phone Number: +48223179421
    • Sub-Investigator: Kamila Indulska
    • Principal Investigator: Katarzyna Dżygało

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
• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: group A; On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal. The 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 glulisine; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Names: Apidra®; Drug: Insulin aspart; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro 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®
Active Comparator: group B; On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal. The 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 glulisine; A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial; Other Names: Apidra®; Drug: Insulin aspart; A kind of study bolus insulin will be insulin lispro if participant used insulin lispro 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®

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)	30 minutes after the meal
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 (SMBG)	90 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	120 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	150 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	180 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	210 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	240 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	270 minutes after the meal
Postprandial glycemia	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	300 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	5-hour study period
Glucose Area Under the Curve (AUC)	Measurements based on CGMS	5-hour study period
Mean amplitude of glycemic excursion	measurements based on SMBG	5-hour study period
The difference between the maximum and baseline glucose level	Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG)	5-hour study period

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Katarzyna Dżygało, Department of Pediatrics, Warsaw Medical University; Study Director: Kamila Indulska, University of Alberta; Study Chair: Agnieszka Szypowska, University of Alberta

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: February 12, 2016
• First Submitted That Met QC Criteria: February 12, 2016
• First Posted (Estimate): February 18, 2016

Study Record Updates

• Last Update Posted (Estimate): July 29, 2016
• Last Update Submitted That Met QC Criteria: July 28, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: insulin pump; diabetes type 1; dietary protein; prandial insulin requirement; pure protein meal; high protein meal; square bolus; square-wave bolus; insulin bolus
• 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: Białko_5h

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No