Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)
|ClinicalTrials.gov Identifier: NCT00542334|
Recruitment Status : Completed
First Posted : October 11, 2007
Last Update Posted : January 26, 2010
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|
|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|
- Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ]
- Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ]
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
|Children's Hosiptal of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Alexandra H Ahmet, MD, BSc,FRCPC||Children's Hospital of Eastern Ontario|