Super-Bolus: Effects on Postprandial Glycemia After High Glycemic Index Meal
NCT ID: NCT04019821
Last Updated: 2023-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
72 participants
INTERVENTIONAL
2020-01-01
2023-04-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Normal Bolus
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).
Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Super Bolus
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.
Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Interventions
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Insulin Glulisine
A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
Insulin Aspart
A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
Insulin Lispro
A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
10 Years
18 Years
ALL
No
Sponsors
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Medical University of Warsaw
OTHER
Responsible Party
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Principal Investigators
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Agnieszka Szypowska, Prof.
Role: STUDY_CHAIR
Department of Pediatrics, Medical University of Warsaw
Locations
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Department of Pediatric Diabetology and Pediatrics, Pediatric Teaching Clinical Hospital
Warsaw, , Poland
Countries
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References
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Kowalczyk-Korcz E, Dyminska M, Szypowska A. Super Bolus-A Remedy for a High Glycemic Index Meal in Children with Type 1 Diabetes on Insulin Pump Therapy?-A Randomized, Double-Blind, Controlled Trial. Nutrients. 2024 Jan 16;16(2):263. doi: 10.3390/nu16020263.
Kowalczyk E, Dzygalo K, Szypowska A. Super Bolus: a remedy for a high glycemic index meal in children with type 1 diabetes on insulin pump therapy?-study protocol for a randomized controlled trial. Trials. 2022 Mar 29;23(1):240. doi: 10.1186/s13063-022-06173-4.
Other Identifiers
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SuperBolus
Identifier Type: -
Identifier Source: org_study_id