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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 10, 2007 | ||||
| Last Updated Date | December 4, 2008 | ||||
| Start Date ICMJE | September 2008 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3 days ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Frequency and magnitude of nocturnal hypoglycemia [ Time Frame: 3-5 days ] | ||||
| Change History | Complete list of historical versions of study NCT00542334 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Patient satisfaction with continuous glucose sensing [ Time Frame: 3 days ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
patient satisfaction with continuous glucose sensing [ Time Frame: 3-5 days ] | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Prevalence of Nocturnal Hypoglycemia in Children on a Type 1 Diabetes (TID) Insulin Regimen Using a Continuous Glucose Monitoring System (CGMS) | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Case-Only, Cross-Sectional | ||||
| Condition ICMJE |
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| Intervention ICMJE | |||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 30 | ||||
| Estimated Completion Date | April 2009 | ||||
| Estimated Primary Completion Date | March 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 2 Years to 18 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00542334 | ||||
| Responsible Party | Dr. Alexandra Ahmet, Children's Hospital of Eastern Ontario | ||||
| Study ID Numbers ICMJE | 07/02S(E) | ||||
| Study Sponsor ICMJE | Children's Hospital of Eastern Ontario | ||||
| Collaborators ICMJE | The Physicians' Services Incorporated Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | Children's Hospital of Eastern Ontario | ||||
| Verification Date | November 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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