Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
McGill University Canadian Diabetes Association |
---|---|
Information provided by: | McGill University |
ClinicalTrials.gov Identifier: | NCT00475345 |
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.
Condition | Intervention |
---|---|
Type 1 Diabetes Mellitus |
Behavioral: Bedtime snacks |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
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 |
Enrollment: | 29 |
Study Start Date: | August 2000 |
Study Completion Date: | September 2001 |
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 analogue(lispro) 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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Quebec | |
Royal Victoria Hospital | |
Montreal, Quebec, Canada, H3A-1A1 |
Principal Investigator: | Jean_Francois Yale, MD | McGill Nutrition and Food Science Centre |
Study ID Numbers: | A05-M27-00 |
Study First Received: | May 16, 2007 |
Last Updated: | May 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00475345 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Nocturnal hypoglycemia Bedtime snacks Continuous glucose monitoring |
Continuous subcutaneous insulin infusion CSII Intensive therapy |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases Diabetes Mellitus Type 1 |
Endocrinopathy Glucose Metabolism Disorders Hypoglycemia Metabolic Disorder Insulin |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia |