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

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: Insulin glulisine; Drug: Insulin aspart

• Registration Number: NCT01678235
• Lead Sponsor: Medical University of Warsaw

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).

Study Timeline

• Study Start: 2011-09
• Status Verified: 2012-08
• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-08-31
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Study First Posted: 2012-09-03
• Last Update Submitted: 2014-10-06
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASP_GLU	Insulin glulisine	Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin aspart Second day: insulin glulisine
GLU_ASP	Insulin glulisine	Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin glulisine Second day: insulin aspart
GLU_ASP	Insulin aspart	Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin glulisine Second day: insulin aspart
ASP_GLU	Insulin aspart	Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial. First day: insulin aspart Second day: insulin glulisine

Primary Outcome Measures

Name	Time	Method
Postprandial glycemia	baseline, 30, 60, 90, 120 and 180 minutes after the breakfast

Secondary Outcome Measures

Name	Time	Method
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
Difference between the maximum and baseline glycemia	3-h study period

Trial Locations

Locations (1)

Department of Pediatrics, Medical University of Warsaw, Poland; 🇵🇱 Warsaw, Poland