Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Insulin Glulisine; Drug: Insulin Aspart; Drug: Insulin Lispro

• Registration Number: NCT04019821
• Lead Sponsor: Medical University of Warsaw

Brief Summary

The aim of this study is to determine whether Super-Bolus is more effective in postprandial glycemic control than Normal-Bolus after the high glycemic index (H-GI) meal in children with type 1 diabetes (T1DM) treated with insulin pump (continuous subcutaneous insulin infusion, CSII).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-12
• Study First Posted: 2019-07-15
• Study Start: 2020-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-04-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• duration of type 1 diabetes longer than 12months,
• insulin pump therapy longer than 3 months,
• written informed consent to participate in the study signed by parents (and patient older than 16 years).

Exclusion Criteria

• celiac disease,
• diabetes related complications (e.g. nephropathy),
• BMI at or above the 95th percentile and at or below 3rd percentiles for children and teenagers of the same age and sex,
• withdrawal of consent to participate in the study,
• comorbid conditions and treatment which could significantly affect glycemic values in the researchers' opinion.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Bolus	Insulin Glulisine	Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
Normal Bolus	Insulin Aspart	Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
Normal Bolus	Insulin Lispro	Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).
Super Bolus	Insulin Glulisine	Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.
Super Bolus	Insulin Aspart	Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.
Super Bolus	Insulin Lispro	Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.

Primary Outcome Measures

Name	Time	Method
Postprandial Glycemia	90 minutes after the prandial bolus	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia Episodes	3-hours after the prandial bolus	Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms
Glucose Area Under the Curve (AUC)	3-hours after the prandial bolus	Measurements based on Continuous Glucose Monitoring System (CGMS)
Mean amplitude of glycaemic excursion (MAGE)	3-hours after the prandial bolus	MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations
Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus	3-hours after the prandial bolus	measured by SMBG
Glycemic rise (GR)	3-hours after the prandial bolus	a difference between baseline and the maximum glucose value based on CGMS
Peak glucose level (PG)	3-hours after the prandial bolus	the maximum value of glycemia during 3 hours of postmeal time based on CGMS
Time to glucose peak	3-hours after the prandial bolus	based on CGMS
Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)	3-hours after the prandial bolus	based on CGMS

Trial Locations

Locations (1)

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital; 🇵🇱 Warsaw, Poland