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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)

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ClinicalTrials.gov Identifier: NCT00542334
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : January 26, 2010
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Children's Hospital of Eastern Ontario

Brief Summary:

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 or disease
Nocturnal Hypoglycemia Type 1 Diabetes

Study Type : Observational
Actual Enrollment : 30 participants
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
Study Start Date : September 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ]

Secondary Outcome Measures :
  1. Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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)
First Posted: October 11, 2007    Key Record Dates
Last Update Posted: January 26, 2010
Last Verified: November 2008

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