Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring

Stanford University

Status: Withdrawn

Conditions: Diabetes Mellitus

Treatments: Device: Navigator Continuous Glucose Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT00796848

Stanford eprotocol #14728 (Other Identifier)

SU-10172008-1323

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 7 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)