Diabetes MellitusNCT00796848
Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
A study testing Navigator Continuous Glucose Monitor in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 20 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Navigator Continuous Glucose Monitor
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Navigator Continuous Glucose Monitor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator Continuous Glucose MonitorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Why it stopped: withdrawn because the research efforts at that time followed another path
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver
- Responsible party
- Principal investigator, Bruce A. Buckingham, Stanford University
- Investigators
- Bruce A. Buckingham, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796848
- Sponsor's protocol ID
- SU-10172008-1323
- Other IDs
- Stanford eprotocol #14728
- Status last verified
- Jun 2018
- First submitted
- 23 Oct 2008
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversal of Hypoglycemia Unawareness Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT00796848
- Acronym / sponsor ID
- SU-10172008-1323
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: withdrawn because the research efforts at that time followed another path
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 7 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigator Continuous Glucose Monitor | Device | – |
Primary outcome
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.
1 secondary outcome
To assess the levels of epinephrine production in youth diagnosed with hypoglycemia unawareness with and without continuous glucose monitor wear.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Stanford Pediatric Endocrinology Department websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce A. Buckingham principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator Continuous Glucose Monitor in people with Diabetes Mellitus, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effectiveness of continuous glucose monitoring in the reduction of hypoglycemia unawareness.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.