Bruce Buckingham
Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. We think that if we take into account how quickly your blood sugar (glucose) is dropping we can stop your basal insulin from your pump for 2 hours and keep you from going low. We hope that what we learn from this study can be used to set up communication between a continuous glucose monitor and an insulin pump. However, we do not currently know the best way to do this.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Device: Navigator Continuous Glucose Monitor
Phase:
N/AEligibility
Ages Eligible for Study:
12 years to 46 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
The inclusion criteria for this study includes the following:
1) Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year.
2) Age 12.0 years to less than 46.0 years old.
3) Subject has used a downloadable insulin pump for at least 3 months
4) Parent/guardian and subject understand the study protocol and agree to comply with it.
5) Subjects >12.0 years old and primary care giver (i.e., parent or guardian) comprehend written English.
6) Subject has a home computer with email access.
7) For females, subject not intending to become pregnant during the study.
8) No expectation that subject will be moving out of the area of the clinical center during the study.
9) Informed Consent Form signed by the parent/guardian and Child Assent Form signed by subjects ages 12 to 17 years.
10) Subjects cannot have had a severe hypoglycemic event, as described as a seizure, loss of consciousness, severe neurological impairment, or neurological impairment suggestive of hypoglycemia and requiring an emergency department visit or hospitalization within 18 months of enrollment.
Key Exclusion Criteria:
The exclusion criteria for this study is the following:
1) The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol
2) The presence of any of the following diseases:
?Asthma if treated with systemic or inhaled corticosteroids in the last 6 months
?Cystic fibrosis
?Angina (recurrent heart pain)
?Past heart attack or coronary artery (heart vessel) disease
?Past stroke or impairment of blood flow to the brain
?Other major illness that in the judgment of the investigator might interfere with the completion of the protocol
Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
3) Inpatient psychiatric treatment in the past 6 months for either the subject or the subject?s primary care giver (i.e., parent or guardian)
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
Additional Study Details
Official Title:
Development of Algorithms for a Hypoglycemic Prevention AlarmAnticipated start date:
5/21/2007Lead Sponsor:
Stanford UniversityCollaborator(s):
- Barbara Davis Center for Childhood Diabetes, U. of Colorado
Investigator(s):
Study Type:
InterventionalPurpose:
OtherAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- The prevention of nocturnal hypoglycemia defined as blood sugar less than 60 mg/dl.
Secondary Outcomes:
- Blood sugar values above 180 mg/dl.
Total Number to be Enrolled:
80Total Number to be Enrolled at Stanford:
40More Information
Secondary ID(s):
- Stanford eprotocol # 6789
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
4/8/2009PLEASE 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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