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

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

Sponsors

Lead Sponsor: Medical University of Warsaw

Source Medical University of Warsaw
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).

Overall Status Not yet recruiting
Start Date June 2020
Completion Date July 2023
Primary Completion Date July 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Postprandial Glycemia 60 minutes after the prandial bolus
Secondary Outcome
Measure Time Frame
Hypoglycemia Episodes 3-hours after the prandial bolus
Glucose Area Under the Curve (AUC) 3-hours after the prandial bolus
Mean amplitude of glycaemic excursion (MAGE) 3-hours after the prandial bolus
Capillary blood glucose level 30,90,120,150,180 min after administration of the prandial bolus 3-hours after the prandial bolus
Glycemic rise (GR) 3-hours after the prandial bolus
Peak glucose level (PG) 3-hours after the prandial bolus
Time to glucose peak 3-hours after the prandial bolus
Time in postprandial glucose range between 70 to 180 mg/dl (4.0-10.0 mmol/L) 3-hours after the prandial bolus
Enrollment 70
Condition
Intervention

Intervention Type: Drug

Intervention Name: Insulin Glulisine

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

Other Name: Apidra

Intervention Type: Drug

Intervention Name: Insulin Aspart

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

Other Name: NovoRapid

Intervention Type: Drug

Intervention Name: Insulin Lispro

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

Other Name: Humalog, Liprolog

Eligibility

Criteria:

Inclusion Criteria:

- duration of type 1 diabetes longer than 12months

- insulin pump therapy longer than 3 months

- written informed consent by patients and parents

Exclusion Criteria:

- withdrawal of consent to participate in the study

- diabetes related complications (e.g. nephropathy)

- celiac disease

- any disease judged by the investigator to affect the trial

Gender: All

Minimum Age: 10 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Agnieszka Szypowska, Prof. Study Chair Department of Pediatrics, Medical University of Warsaw
Overall Contact

Last Name: Emilia Kowalczyk

Phone: +48 223179538

Email: [email protected]

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Normal Bolus

Type: Active Comparator

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).

Label: Super Bolus

Type: Experimental

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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov