Diabetes6-DayFUNCT00865345
An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
A study testing MMT-7003 subcutaneous glucose sensor in people with Diabetes, run by Medtronic MiniMed, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes
- What is being tested?
- MMT-7003 subcutaneous glucose sensor
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females aged 18 through 75 inclusive
- Type 1 Diabetes Mellitus treated using either CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for a minimum of 3 months
- Willingness to perform required study and data collection procedures and adhere to operating requirements of the Guardian REAL-Time and CGMS iPro Systems
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-Time and iPro Systems
- Willing to participate in a 12 hour frequent blood sampling session during the study
- Subject agrees to comply with the study protocol requirements
- Informed Consent, HIPAA Authorization, and California Experimental Subject Bill of Rights (if applicable) signed by the subject
- The Subject is willing to wear both the Guardian REAL-Time and CGMS iPro Systems for 6 days (~144 hours).
Who cannot join
- The Subject has a history of tape allergies that have not been resolved
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
- Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study
- Subject is currently participating in an investigational study (drug or device)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
AMCR Institute
Escondido, California, 92026
Rainier Clinical Research Center
Renton, Washington, 98057
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
The purpose of this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.
Read the detailed description
The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006.
As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.
- Conditions
- Diabetes
- Being tested
- MMT-7003 subcutaneous glucose sensor
- Keywords
- blood sugar, glucose, sensor
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMT-7003 subcutaneous glucose sensorDevice
Also called Glucose sensor, Blood sugar sensor, glucose monitor, blood sugar monitor
All subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
Measured: Days one through six of sensor use
Secondary outcomes (1)
Device Related Moderate or Device Related Severe Adverse Events
Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.
Measured: days one through six of sensor wear
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Mastrototaro, PHD, Study director, Medtronic MiniMed, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865345
- Sponsor's protocol ID
- CEP 218
- Acronym
- 6-DayFU
- Status last verified
- Nov 2012
- First submitted
- 18 Mar 2009
- Last updated
- 6 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance
- ClinicalTrials.gov ID
- NCT00865345
- Acronym / sponsor ID
- 6-DayFU / CEP 218
- Conditions
- Diabetes
- Keywords
- blood sugar, glucose, sensor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Posted 27 Aug 2012
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 this study is to assess the performance of the subcutaneous glucose sensor over an extended sensor life. The sensor is currently approved for 3 days of use and this study will examine sensor safety and accuracy when used for six days. This study will also test sensor safety and accuracy when inserted in an alternate body location (buttock area in addition to abdomen area). The study hypothesis is that the sensor performance will not greatly diminish when used for six days, or in an alternate insertion area.
Detailed description
The Medtronic MiniMed Subcutaneous Glucose Sensor was originally approved by the FDA for commercialization as part of the Continuous Glucose Monitoring System (CGMS) on June 15, 1999 (PMA 980022). The Sensor is composed of a microelectrode with a thin coating of glucose oxidase beneath several layers of biocompatible membrane. This same sensor is used as part of the Guardian REAL-Time System, the latest advance in continuous glucose monitoring, which is based on the CGMS. Similar to the CGMS, the Guardian REAL-Time System has been developed for use in conjunction with a standard home blood glucose meter. The Guardian REAL-Time received regulatory approval from the FDA in 2006.
As currently used, the Subcutaneous Glucose Sensor is labeled for a maximum use duration of 72 hours, using only the abdomen area as an insertion site. Recent studies have shown that the useful sensor life could extend beyond three days, and it is reasonable to expect a significant percentage of sensors to last six days. It is the goal of this study to confirm sensor performance accuracy data from one of these recent studies. The sensor is also commonly worn in body areas other than the abdomen (such as the buttock). This study will also demonstrate sensor accuracy when used in an alternate site.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females aged 18 through 75 inclusive
- Type 1 Diabetes Mellitus treated using either CSII (continuous subcutaneous insulin infusion) or MDI (multiple daily injections) for a minimum of 3 months
- Willingness to perform required study and data collection procedures and adhere to operating requirements of the Guardian REAL-Time and CGMS iPro Systems
- Willingness to perform at least 4 capillary blood glucose tests per day while wearing the Guardian REAL-Time and iPro Systems
- Willing to participate in a 12 hour frequent blood sampling session during the study
Key exclusion criteria (4 listed)
- The Subject has a history of tape allergies that have not been resolved
- The Subject has any skin abnormality (e.g. psoriasis, rash, staphylococcus infection) that has not been resolved and would inhibit them from wearing the sensors
- Any additional condition(s) that in the Investigator's opinion would warrant exclusion from the study or prevent the Subject from completing the study
- Subject is currently participating in an investigational study (drug or device)
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 |
|---|---|---|
| MMT-7003 subcutaneous glucose sensorAlso: Glucose sensor, Blood sugar sensor, glucose monitor, blood sugar monitorAll subjects will use the glucose sensor, randomized to participate in a 12-hour frequent (15-minute) blood glucose sampling period on one of six days of sensor wear. Blood samples will be analyzed using a laboratory standard (YSI) for comparison to the glucose sensor to evaluate accuracy. | Device | – |
Primary outcome
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)
Time frame: Days one through six of sensor use
The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI <80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.
1 secondary outcome
Device Related Moderate or Device Related Severe Adverse Events
Time frame: days one through six of sensor wear
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
John Mastrototaro, PHD study director
Medtronic MiniMed, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMT-7003 subcutaneous glucose sensor in people with Diabetes, run by Medtronic MiniMed, Inc. at 3 sites 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 8 inclusion and 4 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 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 27 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments) (time frame: Days one through six of sensor use). 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 Nov 2012.