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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04019821
• Other study ID #: SuperBolus
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: November 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: April 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
• Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
• Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Locations

Country	Name	City	State
Poland	Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial Glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)	90 minutes after the prandial bolus
Secondary	Hypoglycemia Episodes	Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms	3-hours after the prandial bolus
Secondary	Glucose Area Under the Curve (AUC)	Measurements based on Continuous Glucose Monitoring System (CGMS)	3-hours after the prandial bolus
Secondary	Mean amplitude of glycaemic excursion (MAGE)	MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations	3-hours after the prandial bolus
Secondary	Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus	measured by SMBG	3-hours after the prandial bolus
Secondary	Glycemic rise (GR)	a difference between baseline and the maximum glucose value based on CGMS	3-hours after the prandial bolus
Secondary	Peak glucose level (PG)	the maximum value of glycemia during 3 hours of postmeal time based on CGMS	3-hours after the prandial bolus
Secondary	Time to glucose peak	based on CGMS	3-hours after the prandial bolus
Secondary	Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)	based on CGMS	3-hours after the prandial bolus