Clinical trial

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

NCT04019821

Name

SuperBolus

Description

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).

Trial arms

Trial start

2020-01-01

Estimated PCD

2023-01-01

Trial end

2023-04-01

Status

Completed

Phase

Early phase I

Treatment

Insulin Glulisine

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

Arms:

Normal Bolus, Super Bolus

Other names:

Apidra

Insulin Aspart

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

Arms:

Normal Bolus, Super Bolus

Other names:

NovoRapid

Insulin Lispro

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

Arms:

Normal Bolus, Super Bolus

Other names:

Humalog, Liprolog

Size

Primary endpoint

Postprandial Glycemia

90 minutes after the prandial bolus

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 72, 'type': 'ACTUAL'}}

Updated at

2023-11-30

1 organization

3 products

2 indications

Organization

Medical University of Warsaw

Product

Indication

Indication

Product

Product