The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal.

Medical University of Warsaw

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 1

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04124302

Mixed Meal Bolus

Details and patient eligibility

About

The aim of the study is to compare the impact of two different insulin dose calculation on postprandial glycemia after mixed meal in children with type 1 diabetes mellitus.

Enrollment: 76 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• duration of type 1 diabetes longer than 12 months
• insulin pump therapy longer than 3 months
• treated by the same type of insulin longer than 3 months
• written informed consent by patients and parents

Exclusion criteria

• celiac disease
• diabetes related complications (e.g. nephropathy)
• any disease judged by the investigator to affect the trial
• withdrawal of consent to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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76 participants in 2 patient groups

IPF

Active Comparator group

Description:

Total meal bolus will consist of insulin for carbohydrates (IC) and insulin for proteins and fats (IPF) based on individual insulin-to-carbohydrate ratio (ICR). Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).

Treatment:

Drug: Insulin Aspart

Drug: Insulin Lispro

Drug: Insulin Glulisine

30%IC

Experimental group

Description:

Total meal bolus will consist of insulin for carbohydrates (IC) calculated based on individual insulin-to-carbohydrate ratio (ICR) and insulin for proteins and fats (IPF) estimated as 30% of IC. Dual bolus will be given 15 minutes before the mixed meal (toast with cheese).

Treatment:

Drug: Insulin Aspart

Drug: Insulin Lispro

Drug: Insulin Glulisine