Type 1 Diabetes MellitusNCT00596323
Implantable Antenna Sensors for Continuous Glucose Monitoring
An observational study of Type 1 Diabetes Mellitus, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2008
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults
Who may be able to join
- Healthy adult able to give a blood sample
Who cannot join
- Adults with diabetes or other glycemic or hematologic disorders.
- Sick adults
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama Children's Hospital
Birmingham, Alabama, 35213
About this study
The researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels.
Read the detailed description
Our goal is to develop a small size implantable device that can continually monitor glucose levels. The scientific objective of this application is to examine the efficacy of using implantable antennas to measure the glucose levels. The central hypothesis of this application is that the changes in the glucose levels in the medium surrounding the antenna will affect the antenna parameters such as input impedance and resonance frequency, and these changes can be used to predict the patient's glucose levels. We have formulated this hypothesis on the basis of our preliminary data, which will be detailed later, in the Preliminary Studies section. The rationale for the proposed research is that, once the correlation between the glucose levels and antenna parameters are determined, the design of a miniaturized long term glucose monitoring device will become a reality.
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- antenna, continuous glucose monitoring, electromagnetic
- Medical subject headings
- Diabetes Mellitus, Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Investigators
- Elaine Moreland, MD, Study director, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596323
- Sponsor's protocol ID
- X070207013
- Status last verified
- Dec 2009
- First submitted
- 7 Jan 2008
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implantable Antenna Sensors for Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT00596323
- Acronym / sponsor ID
- X070207013
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- antenna, continuous glucose monitoring, electromagnetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Juvenile Diabetes Research Foundation
- Study start
- Jun 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Jan 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 researchers' long-term goal is to develop a small implantable device that can continually monitor glucose levels. This will be an antenna. Changes in the glucose levels in will affect the antenna signals and those can be used to predict the patient's glucose levels.
Detailed description
Our goal is to develop a small size implantable device that can continually monitor glucose levels. The scientific objective of this application is to examine the efficacy of using implantable antennas to measure the glucose levels. The central hypothesis of this application is that the changes in the glucose levels in the medium surrounding the antenna will affect the antenna parameters such as input impedance and resonance frequency, and these changes can be used to predict the patient's glucose levels. We have formulated this hypothesis on the basis of our preliminary data, which will be detailed later, in the Preliminary Studies section. The rationale for the proposed research is that, once the correlation between the glucose levels and antenna parameters are determined, the design of a miniaturized long term glucose monitoring device will become a reality.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults
Key inclusion criteria (1 listed)
- Healthy adult able to give a blood sample
Key exclusion criteria (2 listed)
- Adults with diabetes or other glycemic or hematologic disorders.
- Sick adults
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2009.
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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.
Elaine Moreland, MD study director
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by University of Alabama at Birmingham 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 1 inclusion and 2 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: finished, as of the sponsor's last update on 2 Dec 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 2 Dec 2009.