Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06141629
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2023-01-26
Brief Title:
Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Benefits of a Bolus Calculator on pre-and Postprandial Glycaemic Control and Meal Flexibility of Pediatric Patients on Multiple Daily Insulin Injections
Status:
COMPLETED
Status Verified Date:
2011-09
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:
It it hypothesized that children and adolescents with type 1 diabetes who are counting carbohydrates can achieve better metabolic control by concurrent use of the Accu-Chek Aviva Expert Additionally it is proposed that carbohydrate counting in combination with the the Accu-Chek Aviva Expert will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose
Detailed Description:
Carbohydrate Carb counting is a meal planning approach for patients with diabetes mellitus that focuses on carbohydrate as the primary nutrient affecting postprandial glycaemic response In the early 1990s the Diabetes Control and Complications Trial DCCT used Carb counting as one of its education tools More recently short acting insulin analogues and insulin pumps have made the role of Carb counting important and popular Carb counting can be used to estimate carbohydrate intake and adjust insulin around mixed meals and snacks using insulin to carbohydrate ratio This effectively addresses the variable eating habits of most children and adolescents Carb counting can make food planning more flexible and thus more acceptable for young patients with diabetes
Roche has recently launched the Accu-Chek Aviva Expert recently preliminary tested in adults4 being a blood glucose meter with integrated bolus calculator and memory function This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters Current blood glucose grams of carbohydrate carbohydrate to insulin ratio insulin sensitivity target blood glucose and insulin action time
Hypothesis
It is hypothesized that paediatric patients in MDI therapy with suboptimal regulated diabetes will achieve better glycemic control by using Accu-Chek Aviva Expert rather than carbohydrate counting alone without the use of an external calculator
Roche has recently launched the Accu-Chek Aviva Expert recently preliminary tested in adults4 being a blood glucose meter with integrated bolus calculator and memory function This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters Current blood glucose grams of carbohydrate carbohydrate to insulin ratio insulin sensitivity target blood glucose and insulin action time
Hypothesis
It is hypothesized that paediatric patients in MDI therapy with suboptimal regulated diabetes will achieve better glycemic control by using Accu-Chek Aviva Expert rather than carbohydrate counting alone without the use of an external calculator
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None