Bruce Buckingham
Reversal of hypoglycemia unawareness using continuous glucose monitoring
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Navigator Continuous Glucose Monitor
Phase:
N/AEligibility
Ages Eligible for Study:
7 years to 20 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
(1) Be at least 7 to 20 years old
(2) Have been diagnosed with type 1 diabetes for at least 1 year
(3) Report 2 or more episodes per week of asymptomatic hypoglycemia as determined by completion of the Hypoglycemia Awareness Questionnaire (HAQ) or as determined by Investigator
(4) HbA1c level < 10%
(5) Internet access for downloading continuous glucose monitoring (CGM), access to a PC compatible computer (Windows Vista is not compatible for downloading.)
(6) For females, you are not intending to become pregnant during the study
(7) No expectation that you will be moving out of the area for the duration of the study
Key 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 protocol
(2) Treatment with systemic or inhaled corticosteroids in the last six months
(3) Inpatient psychiatric treatment in the past six months for you or your primary caregiver
(4) Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the Investigator would be a contraindication to participation in the study
(5) Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
(6) Having a severe hypoglycemic episode in the 30 days prior to enrollment
Additional Study Details
Official Title:
Reversal of hypoglycemia unawareness using continuous glucose monitoringAnticipated start date:
3/1/2009Lead Sponsor:
Stanford UniversityCollaborator(s):
- Barbara Davis Center for Childhood Diabetes, U. of Colorado
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Cross OverEndpoints:
Safety/EfficacyPrimary Outcomes:
- To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
Secondary Outcomes:
- To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
Total Number to be Enrolled:
40Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- Stanford eprotocol #14728
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
2/27/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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