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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00884611
First received: April 17, 2009
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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. The investigators think that if they 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. The investigators hope that what they learn from this study can be used to set up communication between a continuous glucose monitor and an insulin pump. However, the investigators do not currently know the best way to do this.


Condition Intervention
Diabetes Mellitus
Device: Medtronic Real Time Continuous Glucose monitor

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Development of Algorithms for a Hypoglycemic Prevention Alarm

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • The prevention of nocturnal hypoglycemia defined as blood sugar less than 60 mg/dl. [ Time Frame: 7/2011 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood sugar values above 180 mg/dl. [ Time Frame: 7/2011 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2007
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Detailed Description:

The study is expected to include a maximum of 80 people who have type 1 diabetes and are between the ages of 12 - 46 years old.

Your involvement in this research study is expected to take approximately 3-9 months depending on your decision to continue using the Navigator Continuous Glucose Monitor.

Each subject will have one enrollment visit of approximately 2 hours. You will then return for one or two 14 hour overnight hospital admissions in the Clinical Research Center (CRC). After the CRC visit(s) you will be given the option to continue using a Navigator CGM at home for an additional 13 weeks. If you decide to continue use of the Navigator you will be scheduled for an additional phone consult or visit to Stanford one week after your hospital admission. In addition, you will be required to return to Stanford for a final 13 week visit.

  Eligibility

Ages Eligible for Study:   12 Years to 46 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884611

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Stanford University
University of Colorado, Denver
Investigators
Principal Investigator: Bruce A. Buckingham Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Erin Cobry, BS, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00884611     History of Changes
Other Study ID Numbers: SU-10162008-1321, Stanford eprotocol # 6789
Study First Received: April 17, 2009
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014