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

NCT04019821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2023-11-30

No results posted yet for this study

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

Interventions

DRUG

Insulin Glulisine

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

DRUG

Insulin Aspart

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

DRUG

Insulin Lispro

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

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Agnieszka Szypowska, Prof. · Department of Pediatrics, Medical University of Warsaw

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2023-01-01
Completion
2023-04-01

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04019821 on ClinicalTrials.gov