Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783376
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2021-02-24
Brief Title:
Effect of Splitting Mealtime Insulin Doses After Mixed Meals High in Fat and Protein
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Effect of Splitting Mealtime Insulin Doses Used for Mixed Meals High in Fat and Protein on Postprandial Blood Glucose Levels in Children and Adolescents With Type 1 Diabetes Mellitus Using Multiple Daily Injection Regimen
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The current management of type 1 diabetes mellitus T1DM depends on the use of intensive insulin therapy - either by insulin pump therapy or multiple daily injection MDI therapy - and the use of carbohydrate counting to determine the mealtime bolus insulin dose according the carbohydrate contents of each meal or snack However several studies reported that the fat and protein contents of the meals can also affect the postprandial blood glucose levels and result in delayed postprandial hyperglycemia especially after high fat and protein meals
There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals
There is no widely accepted regimen to calculate insulin required for the fat and protein contents of meals especially for patients using multiple daily injection regimen This study aims to find a better method to cover the increased insulin requirements following mixed fat and protein meals The study will compare the effect of splitting mealtime bolus insulin doses into pre-meal and post-meal portions to the standard regimen which involve giving bolus dose depending on carbohydrate content only with additional correction doses 2 to 3 hours after the meal to compensate for the postprandial hyperglycemia induced by fat and protein content of the meals
Detailed Description:
The study will include children and adolescents aged 6 - 18 years diagnosed with T1DM for at least 1 year using multiple daily injection regimen and carbohydrate counting The study participants will be admitted at the pediatric department Sohag University Hospital for 1 week to adjust insulin doses adjustments will be made to basal doses insulin to carbohydrate ratio ICR insulin sensitivity factor ISF if required
The study participants will have three test lunch meals on 3 consecutive days consumed at the pediatric department Sohag university hospital at 12 PM The test meals will consist of two slices of a deep pan pizza base topped with tomato sauce mozzarella full fat soft cheese and minced beef weight 150 g carb 40 g fat 15 g protein 20 g total calories 360 kcal The meal will be consumed within 20 minutes
Blood glucose level before the meal should be between 80 to 150 mgdl Correction doses can be given 3 hours before the test if needed to bring the blood glucose level to the desired target range before the test meals
The participant will be assigned to use each one of the following interventions on a separate day in a random sequence
Intervention A the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100 of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR If hyperglycemia blood glucose level 180 mgdl developed after 3 hours the participant will receive an additional correction dose of fast-acting insulin calculated according to the individual insulin sensitivity factor ISF
Intervention B the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR and additional 30 of the calculated dose will added to cover the fat and protein content of the meal This total dose will be divided into 2 portions A premeal portion 60 of the total dose will be given 10 minutes before the meal The remaining 40 of the total dose will be given 30 minutes after the premeal dose Both doses will be given as fast-acting insulin
Intervention C the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR and additional 30 of the calculated dose will added to cover the fat and protein content of the meal This total dose will be divided into 2 portions A premeal portion 60 of the total dose will be given 10 minutes before the meal as fast-acting insulin The remaining 40 of the total dose will be given 30 minutes after the premeal dose as regular insulin
Types of insulin insulin lispro Humalog 100 IUmL as fast-acting insulin and regular insulin Humulin R as regular insulin Eli Lilly and Company Indianapolis IN USA Insulin doses will be calculated splitted approximated to the nearest 05 unit and given using Humapen Luxura half- unit increments insulin pens
Capillary blood glucose level will be measured by a calibrated finger-prick blood glucose meter before the meals and every hour for the next 6 hours after the test meals Moreover venous blood glucose and serum cholesterol and triglycerides levels will be measured 3 hours after the test meals
The study participants will have three test lunch meals on 3 consecutive days consumed at the pediatric department Sohag university hospital at 12 PM The test meals will consist of two slices of a deep pan pizza base topped with tomato sauce mozzarella full fat soft cheese and minced beef weight 150 g carb 40 g fat 15 g protein 20 g total calories 360 kcal The meal will be consumed within 20 minutes
Blood glucose level before the meal should be between 80 to 150 mgdl Correction doses can be given 3 hours before the test if needed to bring the blood glucose level to the desired target range before the test meals
The participant will be assigned to use each one of the following interventions on a separate day in a random sequence
Intervention A the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100 of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR If hyperglycemia blood glucose level 180 mgdl developed after 3 hours the participant will receive an additional correction dose of fast-acting insulin calculated according to the individual insulin sensitivity factor ISF
Intervention B the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR and additional 30 of the calculated dose will added to cover the fat and protein content of the meal This total dose will be divided into 2 portions A premeal portion 60 of the total dose will be given 10 minutes before the meal The remaining 40 of the total dose will be given 30 minutes after the premeal dose Both doses will be given as fast-acting insulin
Intervention C the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio ICR and additional 30 of the calculated dose will added to cover the fat and protein content of the meal This total dose will be divided into 2 portions A premeal portion 60 of the total dose will be given 10 minutes before the meal as fast-acting insulin The remaining 40 of the total dose will be given 30 minutes after the premeal dose as regular insulin
Types of insulin insulin lispro Humalog 100 IUmL as fast-acting insulin and regular insulin Humulin R as regular insulin Eli Lilly and Company Indianapolis IN USA Insulin doses will be calculated splitted approximated to the nearest 05 unit and given using Humapen Luxura half- unit increments insulin pens
Capillary blood glucose level will be measured by a calibrated finger-prick blood glucose meter before the meals and every hour for the next 6 hours after the test meals Moreover venous blood glucose and serum cholesterol and triglycerides levels will be measured 3 hours after the test meals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None