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

Medical University of Warsaw

Status and phase

Completed

Phase 4

Conditions

Type 1 Diabetes Mellitus

Treatments

Drug: Insulin glulisine

Drug: Insulin aspart

Study type

Interventional

Funder types

Other

Identifiers

NCT01678235

Glulisine_Aspart

Details and patient eligibility

About

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).

Full 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).

Enrollment

64 patients

Sex

All

Ages

10 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

64 participants in 2 patient groups

GLU_ASP

Experimental group

Description:

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

Treatment:

Drug: Insulin aspart

Drug: Insulin glulisine

ASP_GLU

Experimental group

Description:

Treatment:

Drug: Insulin aspart

Drug: Insulin glulisine