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

Phase 4CompletedNCT04019821

Medical University of Warsaw72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin GlulisineDRUG

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

Insulin AspartDRUG

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

Insulin LisproDRUG

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

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital

Warsaw, Poland

Outcomes

Primary Outcomes

Postprandial Glycemia

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

Time frame: 90 minutes after the prandial bolus

Secondary Outcomes

Hypoglycemia Episodes

Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms