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

NCT04019821 | Completed Phase 4

• 1 other identifier: SuperBolus
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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).

Conditions

Diabetes Mellitus, Type 1

Keywords

super bolus; diabetes type 1; insulin bolus; high glycemic index meal; prandial insulin requirement; postprandial glycemia; insulin pump therapy

Outcome Measures

Primary Outcomes (1)

• Postprandial Glycemia

  Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)

  90 minutes after the prandial bolus

Secondary Outcomes (8)

• Hypoglycemia Episodes

  3-hours after the prandial bolus

• Glucose Area Under the Curve (AUC)

  3-hours after the prandial bolus

• Mean amplitude of glycaemic excursion (MAGE)

  3-hours after the prandial bolus

• Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus

  3-hours after the prandial bolus

• Glycemic rise (GR)

  3-hours after the prandial bolus

Study Arms (2)

Normal Bolus

ACTIVE COMPARATOR

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; Drug: Insulin Aspart; Drug: Insulin Lispro

Super Bolus

EXPERIMENTAL

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; Drug: Insulin Aspart; Drug: Insulin Lispro

Interventions

Insulin Glulisine DRUG

A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Also known as: Apidra

Normal Bolus; Super Bolus

Insulin Aspart DRUG

A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.

Also known as: NovoRapid

Normal Bolus; Super Bolus

Insulin Lispro DRUG

A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Also known as: Humalog, Liprolog

Normal Bolus; Super Bolus

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital

Warsaw, Poland

Location

Related Publications (2)

• Kowalczyk-Korcz E, Dyminska M, Szypowska A. Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial. Nutrients. 2024 Jan 16;16(2):263. doi: 10.3390/nu16020263.

  PMID: 38257156 DERIVED

• Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.

  PMID: 35351180 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Agnieszka Szypowska, Prof.

  Department of Pediatrics, Medical University of Warsaw

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

PL (1)