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

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Insulin Aspart; Drug: Insulin Glulisine; Drug: Insulin Lispro

Study type: Interventional

Funder types: Other

Identifiers

NCT04019821

SuperBolus

Details and patient eligibility

About

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).

Enrollment: 72 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Normal Bolus

Active Comparator group

Description:

Pre-breakfast insulin will be given as a Normal Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Normal Bolus will be calculated based on individual insulin-to-carbohydrate ratio (ICR).

Treatment:

Drug: Insulin Lispro

Drug: Insulin Glulisine

Drug: Insulin Aspart

Super Bolus

Experimental group

Description:

Pre-breakfast insulin will be given as a Super Bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The Super Bolus will be calculated based on individual ICR increased to 150% and basal insulin will be suspended for 2 hours at the same time.

Treatment:

Drug: Insulin Lispro

Drug: Insulin Glulisine

Drug: Insulin Aspart