Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01678235

Enrollment

Registered

2012-09-03

Start date

2011-09-30

Completion date

2012-09-30

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetes, insulin pump, glulisine, aspart, glycemic index

Brief summary

The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).

Detailed description

Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).

Interventions

DRUGInsulin glulisine

DRUGInsulin aspart

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

10 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Type 1 diabetes mellitus * CSII for at least 3 months * Duration of diabetes \> 1 years * Informed consent

Exclusion criteria

* Concomitant dietary restrictions (e.g. celiac disease or food allergy) * Diabetes related complications * Baseline hyperglycemia \>150 mg/dl * Any disease judged by the investigator to affect the trial

Design outcomes

Primary

Measure	Time frame
Postprandial glycemia	baseline, 30, 60, 90, 120 and 180 minutes after the breakfast

Secondary

Measure	Time frame	Description
Difference between the maximum and baseline glycemia	3-h study period	—
Hypoglycemia episodes	3-h study period	Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
Glucose Area Under the Curve (AUC)	3-h study period	based on continuous glucose monitoring system
Mean amplitude of glycemic excursion (MAGE)	3-h study period	—

Other

Measure	Time frame
Questionnaire: Glycemic Index Knowledge	each subject was asked to fullfill the questionnaire before entering the study (day one)

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026