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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 is not yet open for participant recruitment.
Verified by Children's Hospital of Eastern Ontario, May 2008

Sponsors and Collaborators: Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Information provided by: Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT00542334
  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. We 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 3-5 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

MedlinePlus related topics:   Diabetes    Diabetes Type 1    Hypoglycemia   

ChemIDplus related topics:   Insulin    Dextrose   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Case-Only, 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

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

Primary Outcome Measures:
  • Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient satisfaction with continuous glucose sensing [ Time Frame: 3-5 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   June 2008
Estimated Study Completion Date:   October 2008

  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 Hospital of Eastern Ontario     Not yet recruiting
      Ottawa, Ontario, Canada, K1H 8L1
      Sub-Investigator: Margaret Lawson, MD, FRCPC, MSc            
      Sub-Investigator: Simon Dagenais, PhD, DC, BA            

Sponsors and Collaborators
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation

Investigators
Principal Investigator:     Alexandra H Ahmet, MD, FRCPC     Children's Hospital of Eastern Ontario    
  More Information


Responsible Party:   Children's Hospital of Eastern Ontario ( Dr. Alexandra Ahmet )
Study ID Numbers:   07/02S(E)
First Received:   October 10, 2007
Last Updated:   May 5, 2008
ClinicalTrials.gov Identifier:   NCT00542334
Health Authority:   Canada: Health Canada

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

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 07, 2008




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