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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

October 10, 2007
January 25, 2010
September 2008
June 2009   (final data collection date for primary outcome measure)
Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3-5 days ]
Complete list of historical versions of study NCT00542334 on ClinicalTrials.gov Archive Site
Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
patient satisfaction with continuous glucose sensing [ Time Frame: 3-5 days ]
Not Provided
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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)
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

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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
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Non-Probability Sample

Children and adolescents with type 1 diabetes

  • Nocturnal Hypoglycemia
  • Type 1 Diabetes
Not Provided
Not Provided
Ahmet A, Dagenais S, Barrowman NJ, Collins CJ, Lawson ML. Prevalence of nocturnal hypoglycemia in pediatric type 1 diabetes: a pilot study using continuous glucose monitoring. J Pediatr. 2011 Aug;159(2):297-302.e1. doi: 10.1016/j.jpeds.2011.01.064. Epub 2011 Mar 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2009
June 2009   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00542334
07/02S(E)
No
Dr. Alexandra Ahmet, Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
The Physicians' Services Incorporated Foundation
Principal Investigator: Alexandra H Ahmet, MD, BSc,FRCPC Children's Hospital of Eastern Ontario
Children's Hospital of Eastern Ontario
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP