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

November 28, 2023 updated by: Medical University of Warsaw

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland
        • Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 14 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal Bolus
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).
Drug: Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Other Names:
  • Apidra
Drug: Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Other Names:
  • NovoRapid
Drug: Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Other Names:
  • Humalog, Liprolog
Experimental: Super Bolus
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.
Drug: Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Other Names:
  • Apidra
Drug: Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Other Names:
  • NovoRapid
Drug: Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Other Names:
  • Humalog, Liprolog

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial Glycemia
Time Frame: 90 minutes after the prandial bolus
Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)
90 minutes after the prandial bolus

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Agnieszka Szypowska, Prof., Department of Pediatrics, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 12, 2019

First Posted (Actual)

July 15, 2019

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SuperBolus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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