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Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)

This study has been completed.
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:
NCT00542334
First received: October 10, 2007
Last updated: January 25, 2010
Last verified: November 2008
History of Changes
  Purpose

This study will help determine the frequency and magnitude of nocturnal hypoglycemia (low blood sugar at night during sleep), in children with type 1 diabetes who are on a standard insulin regimen, by using a Continuous Glucose Monitoring System (CGMS). Secondary objectives include the establishment of a definition of nocturnal hypoglycemia for the CGMS and for the calculation of sample size needed for future studies using CGMS. Nocturnal hypoglycemia (NH) can be associated with significant morbidity including seizure and coma. The investigators intend to use the CGMS in a future study investigating the use of a new insulin combination aimed to decrease the frequency of NH in the pediatric population.

Thirty pediatric subjects with established type 1 diabetes mellitus will be asked to wear a CGMS for 3 days. During this time the participants will be required to test and record self-monitored blood glucose readings at designated time periods and if they have symptoms of hypoglycemia. The comparison of these values with each other and with different previously defined values of NH will allow for a clear definition of NH to be made. A survey has also been designed to assess participant satisfaction with the CGMS.


Condition
Nocturnal Hypoglycemia
Type 1 Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence of Nocturnal Hypoglycemia in Children and Adolescents With Type 1 Diabetes on a Standard (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS) - A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:
  • Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and adolescents with type 1 diabetes

Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • less than 18 years of age
  • >2 year duration of diabetes
  • on a conventional TID insulin regimen (morning and bedtime NPH) for a minimum of 3 months
  • informed consent and assent

Exclusion Criteria:

  • medical conditions other than treated hypothyroidism or asthma requiring oral glucocorticoids more than once per year
  • intention to move outside of CHEO's catchment area within the next 4 months
  • more than 17 years of age and unwilling to continue receiving diabetes care at CHEO until study completion
  • intention to switch to a different insulin regimen prior to study completion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00542334

Locations
Canada, Ontario
Children's Hosiptal of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Alexandra H Ahmet, MD, BSc,FRCPC Children's Hospital of Eastern Ontario
  More Information

No publications provided by Children's Hospital of Eastern Ontario

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dr. Alexandra Ahmet, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00542334     History of Changes
Other Study ID Numbers: 07/02S(E)
Study First Received: October 10, 2007
Last Updated: January 25, 2010
Health Authority: Canada: Health Canada

Keywords provided by Children's Hospital of Eastern Ontario:
Nocturnal Hypoglycemia
Type 1 diabetes
Children
Adolescents
CGMS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013