Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

NCT00796848 | Withdrawn

• 2 other identifiers: SU-10172008-1323Stanford eprotocol #14728
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.

Secondary Outcomes (1)

• To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.

Interventions

Navigator Continuous Glucose Monitor DEVICE

Eligibility Criteria

• Age: 7 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be at least 7 to 20 years old
• Have been diagnosed with type 1 diabetes for at least 1 year
• 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
• HbA1c level \< 10%
• Internet access for downloading continuous glucose monitoring (CGM), access to a compatible computer (Windows Vista is not compatible for downloading.)
• For females, you are not intending to become pregnant during the study
• No expectation that you will be moving out of the area for the duration of the study

You may not qualify if:

• 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
• Treatment with systemic or inhaled corticosteroids in the last six months
• Inpatient psychiatric treatment in the past six months for you or your primary caregiver
• 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
• Having two or more severe hypoglycemia episodes (seizure or loss of consciousness) in the six months prior to enrollment
• Having a severe hypoglycemic episode in the 30 days prior to enrollment

Sponsors & Collaborators

• Stanford University: lead
• University of Colorado, Denver: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Links

• Stanford Pediatric Endocrinology Department website

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Bruce A. Buckingham

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: November 24, 2008
• Study Start: March 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: June 6, 2018

Record last verified: 2018-06

Locations

US (1)