Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475345
Status:
COMPLETED
Last Update Posted:
2007-05-21
First Post:
2007-05-16
Brief Title:
Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia
Sponsor:
McGill University
Organization:
McGill University
Study Overview
Official Title:
Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia in Adults With Type 1 Diabetes Undergoing Intensive Management
Status:
COMPLETED
Status Verified Date:
2007-05
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 purpose of this study is to determine whether or not bedtime snacks are necessary to prevent overnight low blood glucose reactions nocturnal hypoglycemia in adults with type 1 diabetes who are using intensive insulin therapies either multiple injections of insulin or insulin pump
We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered especially by use of insulin pump which is considered the gold standard for overnight blood glucose control
We hypothesize that a bedtime snack is not necessary if the bedtime insulin is very well adjusted and delivered especially by use of insulin pump which is considered the gold standard for overnight blood glucose control
Detailed Description:
Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can lead to many problems including coma and death in the most extreme cases and deterioration of glycemic control Strategies to prevent nocturnal hypoglycemia include development of newer insulins and delivery systems and the use of specific bedtime snack compositions Detection of nocturnal hypoglycemia as it occurs in everyday life has been a problem since most episodes go unnoticed and therefore untreated leading to a very dangerous situation With the recent availability of technology which allows for continuous glucose monitoring it has been made possible to detect nocturnal hypoglycemia as it occurs in daily life As well this technology allows for the possibility of better titration of therapy
Therefore the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life Specifically we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analoguelispro versus multiple daily injections of insulin using the same type of insulin analogue and with and without bedtime snacks Therefore we compared 3 groups 1 insulin pump with no bedtime snacks 2 multiple injections with bedtime snacks and 3 multiple injections with no bedtime snacks The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia Other comparisons included long term glycemic control A1c weight and body composition and quality of life
Therefore the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life Specifically we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analoguelispro versus multiple daily injections of insulin using the same type of insulin analogue and with and without bedtime snacks Therefore we compared 3 groups 1 insulin pump with no bedtime snacks 2 multiple injections with bedtime snacks and 3 multiple injections with no bedtime snacks The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia Other comparisons included long term glycemic control A1c weight and body composition and quality of life
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