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Completed

NCT Number: NCT04019821

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

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital

Warsaw, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

insulin glulisine

Drug

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

Other names: Apidra

insulin aspart

Drug

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

Other names: NovoRapid

Insulin Lispro

Drug

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

Other names: Humalog, Liprolog

Primary outcomes

  1. Postprandial Glycemia

    Time frame: 90 minutes after the prandial bolus

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

Secondary outcomes

  1. 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

  2. Glucose Area Under the Curve (AUC)

    Time frame: 3-hours after the prandial bolus

    Measurements based on Continuous Glucose Monitoring System (CGMS)

  3. 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

  4. 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

  5. Glycemic rise (GR)

    Time frame: 3-hours after the prandial bolus

    a difference between baseline and the maximum glucose value based on CGMS

  6. 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

  7. Time to glucose peak

    Time frame: 3-hours after the prandial bolus

    based on CGMS

  8. 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 15, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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