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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

The Impact of Two Different Insulin Dose Calculation on Postprandial Glycemia After Mixed Meal in Children With Type 1 Diabetes Mellitus- Randomized Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04124302
• Other study ID #: Mixed Meal Bolus
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2019
• Est. completion date: August 2023

Study information

• Verified date: August 2019
• Source: Medical University of Warsaw
• Contact: Magdalena Dyminska, MD
• Phone: +48 223179538
• Email: m.dyminska91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: August 2023
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin Glulisine
A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
• Insulin Aspart
A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
• Insulin Lispro
A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	60 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	120 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	180 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	210 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	240 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	270 minutes after meal
Primary	Postprandial glycemia	Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG).	300 minutes after meal
Secondary	Glucose Area Under the Curve (AUC)	Measurements based on Continuous Glucose Monitoring System (CGMS)	5 hours study period
Secondary	The Difference Between The Maximum and Baseline Glucose Level - mean amplitude of glycaemic excursion (MAGE)	Measurements based on SMBG	5 hours study period
Secondary	Hypoglycemia Episodes	Hypoglycemia defined as a plasma glucose concentration below 70mg/dl with or without symptoms	5 hours study period