Skip to main content
OpenTrials
Completed

NCT Number: NCT00475345

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Victoria Hospital

Montreal, Quebec, H3A-1A1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bedtime snacks

Behavioral

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Canadian Diabetes Association

Registry information

Official study title

Impact of Optimized Titration and Delivery of Bedtime Insulin on Prevention of Nocturnal Hypoglycemia in Adults With Type 1 Diabetes Undergoing Intensive Management

Important dates

Study start
2000
Study completion
2001
First posted
May 21, 2007
Registry last updated
May 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.