Insulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps.
NCT ID: NCT02685449
Last Updated: 2016-07-29
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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UNKNOWN
PHASE4
70 participants
INTERVENTIONAL
2016-02-29
2018-08-31
Brief Summary
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Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.
Detailed Description
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To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and \<100 kcal from protein and fat for the first breakfast (without any extended bolus) Patients receive a standardized pure protein meal at a second breakfast time. Meal insulin will be given as a square bolus or no meal -insulin will be given at all. The 5h post-meal glucose excursions will be recorded by self-blood glucose measurements (SMBG) (every 30 minutes) and continuous glucose monitoring system (CGMS). The intervention is taking part under in-patient clinical conditions.
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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group A
On the first study day, insulin bolus was not given before a standardized pure protein meal. On the second day, pre-breakfast insulin was given as a square-wave bolus before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Insulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
group B
On the first study day, pre-breakfast insulin was given as a square-wave bolus before a standardized pure protein meal. On the second day, insulin bolus was not given before the same standardized pure protein meal.
The fat-protein-insulin ratio on both study days were identical to the patient's ratio when entering trial.
Kind of study bolus insulin will be a rapid-acting insulin analog same as previously used by the participant (before entering the trial) - insulin aspart, insulin lispro or insulin glulisine
Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Insulin lispro
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Interventions
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Insulin glulisine
A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
Insulin aspart
A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
Insulin lispro
A kind of study 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 by patients and parents
* insulin requirement more than 0,5 units/kg/day
Exclusion Criteria
* chronic kidney diseases
* any disease judged by the investigator to affect the trial
* withdrawal of consent to participate in the study
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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Katarzyna Dżygało
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatrics, Warsaw Medical University
Kamila Indulska
Role: STUDY_DIRECTOR
University of Alberta
Agnieszka Szypowska
Role: STUDY_CHAIR
University of Alberta
Locations
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Medical University
Warsaw, , Poland
Countries
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Central Contacts
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Kamila Indulska
Role: CONTACT
Phone: 48223179421
Facility Contacts
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Agnieszka Szypowska, MD, PhD
Role: primary
Other Identifiers
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Białko_5h
Identifier Type: -
Identifier Source: org_study_id