Trial Radar AI | ||
|---|---|---|
Clinical Trial NCT02685449 for Diabetes type1 is unknown status. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
One study matched filter criteria
Card View
Back to Search
Medical University of WarsawInsulin Requirement for Pure-protein Meal in Children With Type 1 Diabetes on Insulin Pumps. Phase 4 70 Randomized
Clinical Trial NCT02685449 is designed to study Treatment for Diabetes type1. It is a Phase 4 interventional study that is unknown status, having started on February 1, 2016, with plans to enroll 70 participants. Led by Medical University of Warsaw, it is expected to complete by August 1, 2018. The latest data from ClinicalTrials.gov was last updated on July 29, 2016.
Brief Summary
This is a randomized, cross-over study. The aim of this study is to compare the post-prandial glycaemic variability after pure protein meal following with an administration of square-wave bolus of meal-insulin or without any meal-insulin bolus on the other day.
Prolonged post-prandial glycaemic variability will be identified using the self-monitoring of blood glucose (10-point curve) and CGMS.
Detailed Description
The square-wave bolus (for meals rich in fat and/or protein) is evenly delivered over several hours as programmed by the patient. The required insulin dose will be calculated based on patient's insulin-exchange ratio. Pure protein meal will be given 3 hours after a first breakfast.
To provide the minimal impact of the previous breakfast, all patients will receive up to 120 kcal of carbohydrates and <100 kcal from p...
Show MoreOfficial Title
Insulin Requirement for Pure- Protein Meal in Children With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion - a Cross-over, Randomized Trial.
Conditions
Diabetes type1Other Study IDs
- Białko_5h
NCT ID Number
Start Date (Actual)
2016-02
Last Update Posted
2016-07-29
Completion Date (Estimated)
2018-08
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
Phase 4
Status
Unknown status
Keywords
diabetes type 1
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
insulin pump
prandial insulin requirement
pure protein meal
high protein meal
square bolus
square-wave bolus
insulin bolus
dietary protein
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo Comparatorgroup 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 th...Show More | 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 |
Active Comparatorgroup 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 th...Show More | 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 30 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 60 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 90 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 120 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 150 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 180 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 210 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 240 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 270 minutes after the meal |
Postprandial glycemia | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 300 minutes after the meal |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Hypoglycemia episodes | Hypoglycemia defined as a plasma glucose concentration below 65 mg/dl with or without symptoms | 5-hour study period |
Glucose Area Under the Curve (AUC) | Measurements based on CGMS | 5-hour study period |
Mean amplitude of glycemic excursion | measurements based on SMBG | 5-hour study period |
The difference between the maximum and baseline glucose level | Post-prandial blood glucose excursions measured by self monitoring of blood glucose (SMBG) | 5-hour study period |
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
10 Years
Eligible Sexes
All
- duration of type 1 diabetes longer than 12 months
- insulin pump therapy longer than 3 months
- written informed consent by patients and parents
- insulin requirement more than 0,5 units/kg/day
- diabetes related complications (e.g. nephropathy)
- chronic kidney diseases
- any disease judged by the investigator to affect the trial
- withdrawal of consent to participate in the study
Medical University of Warsaw79 active studies to exploreStudy Central Contact
Contact: Kamila Indulska, 48223179421
Contact: Katarzyna Dżygało, 48223179538, [email protected]
1 Study Locations in 1 Countries
Medical University, Warsaw, 02- 091, Poland
Agnieszka Szypowska, MD, PhD, Contact, +48223179421
Kamila Indulska, Sub-Investigator
Katarzyna Dżygało, Principal Investigator
Recruiting