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Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia

This study has been completed.

Sponsors and Collaborators: McGill University
Canadian Diabetes Association
Information provided by: McGill University
ClinicalTrials.gov Identifier: NCT00475345
  Purpose

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

MedlinePlus related topics:   Diabetes    Diabetes Type 1    Hypoglycemia   

ChemIDplus related topics:   Insulin    Dextrose   

U.S. FDA Resources

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

Further study details as provided by McGill University:

Primary Outcome Measures:
  • Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c [ Time Frame: end of 3 months for each group ]

Secondary Outcome Measures:
  • Nadir nocturnal BG, timing and duration of nocturnal hypoglycemia, fasting BG, lipid profile, psychosocial factors, total insulin dose, insulin sensitivity and body composition (weight, BMI, % fat, waist circumference). [ Time Frame: end of 3 months for each group ]

Enrollment:   29
Study Start Date:   August 2000
Study Completion Date:   September 2001

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 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.

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Adults with type 1 diabetes for more than 3 years duration and on intensive insulin therapy using multiple daily injections of insulin (MDI) for at least 1 year prior to study.

Exclusion Criteria:

  • Pregnant women or intending to become pregnant in next year,
  • Significant hepatic or renal disease,
  • Active cancer,
  • Abuse of alcohol or drugs.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475345

Locations
Canada, Quebec
Royal Victoria Hospital    
      Montreal, Quebec, Canada, H3A-1A1

Sponsors and Collaborators
McGill University
Canadian Diabetes Association

Investigators
Principal Investigator:     Jean_Francois Yale, MD     McGill Nutrition and Food Science Centre    
  More Information


Study ID Numbers:   A05-M27-00
First Received:   May 16, 2007
Last Updated:   May 17, 2007
ClinicalTrials.gov Identifier:   NCT00475345
Health Authority:   Canada: Ethics Review Committee

Keywords provided by McGill University:
Nocturnal hypoglycemia  
Bedtime snacks  
Continuous glucose monitoring  
Continuous subcutaneous insulin infusion
CSII
Intensive therapy

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia
Insulin

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 10, 2008




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