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WithdrawnNCT00796848Updated Jun 6, 2018

Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

An interventional study of Navigator Continuous Glucose Monitor in Diabetes Mellitus, sponsored by Stanford University. Withdrawn at 1 site in United States. Open to participants aged 7 Years to 20 Years. Per ClinicalTrials.gov, last updated 2018-06-06.

Sponsored by Stanford University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
withdrawn because the research efforts at that time followed another path
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
7 Years to 20 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Diabetes Mellitus

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03

In context

Hypoglycemia

640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.

Browse Hypoglycemia studies →

Lead sponsor

Stanford University is the lead sponsor of 2,117 studies on the registry; 425 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 197 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • DeviceNavigator Continuous Glucose Monitor
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What researchers measure

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.

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Study locations

1 site
  • Stanford University School of Medicine
    Stanford, California 94305, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00796848
Lead sponsor
Stanford University
Collaborators
University of Colorado, Denver
Responsible party
Bruce A. Buckingham (Principle Investigator, Stanford University) — Principal investigator
First posted
Nov 24, 2008
Start date
Mar 2009
Primary completion
Mar 2010 (estimated)
Completion
Mar 2010 (estimated)
Last update
Jun 6, 2018

Study contacts

Bruce A. Buckingham
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

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