Diabetes MellitusNCT02880267
Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
A study testing CGM in people with Diabetes Mellitus, run by DexCom, Inc. at 9 sites in United States.
Trial summary
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2016to Sep 2017
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Ages 2 or older
- Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy
- Willing to participate in a clinic session involving venous sampling for evaluation of study end point
Who cannot join
- Use of acetaminophen
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification of the study-assigned blood glucose meter
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Atlanta Diabetes
Atlanta, Georgia
Barbara Davis Center
Aurora, Colorado
Joslin Diabetes Center
Boston, Massachusetts
AMCR Institute
Escondido, California
Stanford
Palo Alto, California
Oregon Health Science University
Portland, Oregon
Sansum
Santa Barbara, California
Rainier
Seattle, Washington
Diablo
Walnut Creek, California
About this study
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System
Read the detailed description
The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.
The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
- Conditions
- Diabetes Mellitus
- Being tested
- CGM
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.
| Study group | Role | What they receive |
|---|---|---|
| CGM Users | Other | Glucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement Receives: Device: CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
Measured: 10 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionSep 2017
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.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David PRice, MD, Study director, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880267
- Sponsor's protocol ID
- PTL-902220
- Status last verified
- Dec 2018
- First submitted
- 23 Aug 2016
- Last updated
- 31 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of the Dexcom™ G6 Continuous Glucose Monitoring System
- ClinicalTrials.gov ID
- NCT02880267
- Acronym / sponsor ID
- PTL-902220
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Aug 2016 (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.
Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring (CGM) System
Detailed description
The objective of the study is to establish performance of the System compared to a laboratory reference measurement. The effectiveness of the System will be evaluated by comparison of CGM values to a laboratory reference, Yellow Spring Instrument (YSI), using arterialized venous sample measurements. Performance will be evaluated in terms of point and rate accuracy of the System in reference to YSI.
The safety profile of the System will be characterized by the incidence of device-related Adverse Events (AEs) experienced by study subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM Users | Other | Device: CGMGlucose challenge during a clinic sessions to assess performance of CGM compared to reference measurement |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 2 or older
- Diagnosis of Type 1 diabetes or Type 2 diabetes, on intensive insulin therapy
- Willing to participate in a clinic session involving venous sampling for evaluation of study end point
Key exclusion criteria (4 listed)
- Use of acetaminophen
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification of the study-assigned blood glucose meter
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 |
|---|---|---|
| CGMGlucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement. | Device | CGM Users |
Primary outcome
Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL
Time frame: 10 Days
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 31 Dec 2018.
- Individual participant dataSharing planned: No
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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.
David PRice, MD study director
DexCom, Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Diabetes Mellitus, run by DexCom, Inc. at 9 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 3 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 31 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
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.
What does the primary outcome measure?
Proportion of blood glucose values, compared between CGM and a lab glucose analyzer that are matched relative to a proportion of blood glucose values, compared between CGM and a lab glucose analyzer matched to an accuracy measurement of %20/20 mg/dL (time frame: 10 Days). 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 31 Dec 2018.