Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

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.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: Navigator Continuous Glucose Monitor

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 20 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of Colorado, Denver

Publications and helpful links

Helpful Links

• Stanford Pediatric Endocrinology Department website

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): March 1, 2010
• Study Completion (Anticipated): March 1, 2010

Study Registration Dates

• First Submitted: October 23, 2008
• First Submitted That Met QC Criteria: November 21, 2008
• First Posted (Estimate): November 24, 2008

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hypoglycemia
• Other Study ID Numbers: SU-10172008-1323; Stanford eprotocol #14728 (Other Identifier: Stanford IRB)