Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Trial ID or NCT#
NCT00796848
Status
NOT RECRUITING
Purpose
The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. For this study we will be using the Navigator Continuous Glucose Monitor. We think that your body may not have enough of a certain hormone that usually helps people know when they are going low. If you can keep from going low, we think there will be enough of that hormone to help you recognize the symptoms of a low before it happens.
Official Title
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
Eligibility Criteria
Ages Eligible for Study: 7 Years to 20 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
- 1. Be at least 7 to 20 years old2. Have been diagnosed with type 1 diabetes for at least 1 year3. Report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the Hypoglycemia Awareness Questionnaire (HAQ) or as determined by Investigator4. HbA1c level \< 10%5. Internet access for downloading continuous glucose monitoring (CGM), access to a compatible computer (Windows Vista is not compatible for downloading.)6. For females, you are not intending to become pregnant during the study7. No expectation that you will be moving out of the area for the duration of the study
Exclusion Criteria:
- 1. The presence of a significant medical disorder (including epilepsy, or any cause of seizures other than hypoglycemia) that in the judgment of the Investigator will affect the wearing of the sensors or the completion of any aspect of the protocol2. Treatment with systemic or inhaled corticosteroids in the last six months3. Inpatient psychiatric treatment in the past six months for you or your primary caregiver4. Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the Investigator would be a contraindication to participation in the study5. Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment6. Having a severe hypoglycemic episode in the 30 days prior to enrollment
Investigator(s)
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
View on ClinicalTrials.gov
