Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

NCT ID: NCT00796848

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2010-03-31

Brief Summary

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.

Detailed Description

To enroll in this study you must be between the ages of 7 and 20, have type 1 diabetes, and experience at least two episodes of low blood glucose readings weekly that you do not feel. Up to 25 subjects will be enrolled at Stanford and another 25 at the Barbara Davis Center in Colorado. The study will last approximately 8 months for each participant.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Navigator Continuous Glucose Monitor

Intervention Type: DEVICE

Eligibility Criteria

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 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

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce A. Buckingham

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Related Links

http://dped.stanford.edu/

Stanford Pediatric Endocrinology Department website

Other Identifiers

Stanford eprotocol #14728

Identifier Type: OTHER

Identifier Source: secondary_id

SU-10172008-1323

Identifier Type: -

Identifier Source: org_study_id