Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS)
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.
Type 1 Diabetes
|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|
- Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
|Study Start Date:||September 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: 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|