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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Recruiting

Phase

Phase 4

Locations

Poland

Study Type

Interventional

Intervention

Insulin Glulisine

Insulin Aspart

Insulin Lispro

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring super bolus, diabetes type 1, insulin bolus, high glycemic index meal, prandial insulin requirement, postprandial glycemia, insulin pump therapy

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept 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.

Sites / Locations

Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normal Bolus

Super Bolus

Arm 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).

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.

Outcomes

Primary Outcome Measures

Postprandial Glycemia

Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)

Secondary Outcome Measures

Hypoglycemia Episodes

Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms

Glucose Area Under the Curve (AUC)

Measurements based on Continuous Glucose Monitoring System (CGMS)

Mean amplitude of glycaemic excursion (MAGE)

MAGE will be defined as a standard deviation of blood glucose (SDBG) obtained from all blood glucose concentrations

Capillary blood glucose level 30,60,120,150,180 min after administration of the prandial bolus

measured by SMBG

Glycemic rise (GR)

a difference between baseline and the maximum glucose value based on CGMS

Peak glucose level (PG)

the maximum value of glycemia during 3 hours of postmeal time based on CGMS

Time to glucose peak

based on CGMS

Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L)

based on CGMS

Full Information

NCT ID

NCT04019821

First Posted

July 11, 2019

Last Updated

January 27, 2022

Sponsor

Medical University of Warsaw

1. Study Identification

Unique Protocol Identification Number

NCT04019821

Brief Title

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

Official Title

Effects of Super-Bolus on Postprandial Glycemia After High Glycemic Index Meal in Children With Type 1 Diabetes Mellitus- Randomized Study

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

July 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

super bolus, diabetes type 1, insulin bolus, high glycemic index meal, prandial insulin requirement, postprandial glycemia, insulin pump therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Normal Bolus

Arm Type

Active Comparator

Arm Description

Arm Title

Super Bolus

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Insulin Glulisine

Other Intervention Name(s)

Apidra

Intervention Description

A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.

Intervention Type

Drug

Intervention Name(s)

Insulin Aspart

Other Intervention Name(s)

NovoRapid

Intervention Description

A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.

Intervention Type

Drug

Intervention Name(s)

Insulin Lispro

Other Intervention Name(s)

Humalog, Liprolog

Intervention Description

A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.

Primary Outcome Measure Information:

Title

Postprandial Glycemia

Description

Postprandial blood glucose excursion measured by self monitoring of blood glucose (SMBG)

Time Frame

90 minutes after the prandial bolus

Secondary Outcome Measure Information:

Title

Hypoglycemia Episodes

Description

Hypoglycemia defined as a plasma glucose concentration below or equal 70mg/dl with or without symptoms

Time Frame