Development of Algorithms for a Hypoglycemic Prevention Alarm: Closed Loop Study

Not Recruiting

Trial ID: NCT00884611


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. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.

Official Title

Development of Algorithms for a Hypoglycemic Prevention Alarm

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus


Inclusion Criteria:

   1. Age 18 years or older,

   2. Type 1 diabetes for at least 1 year

   3. Current user of the MiniMed Paradigm Real-Time Revel system and Sof-sensor glucose

   4. Hemoglobin A1c level of < 8.0%,

   5. Home computer with access to the Internet,

   6. At least one CGMglucose value < 70 mg/dL during the most recent 15 nights of CGM
   glucose data.

   7. Not pregnant or planning to become pregnant

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

   5. 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


device: Predictive Low Glucose Suspend Algorithm ON

device: Predictive Low Glucose Suspend Algorithm OFF

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305