Diabetes MellitusNCT03087877
Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor
A study testing Acetaminophen Challenge (G6 CGM) in people with Diabetes Mellitus, run by DexCom, Inc. at 4 sites in United States.
Trial summary
The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Acetaminophen Challenge (G6 CGM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Feb 2017to 4 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 18 or older
- Diagnosis of diabetes
Who cannot join
- Pregnancy
- Known gastroparesis
- Abnormal liver function
Trial locations and contacts
4 sites in 1 country.
United States4 sites
AMCR
Escondido, California, 92025
Rainier Clinical Research Center Inc
Renton, Washington, 98057
William Sansum Diabetes Center
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
The objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.
Read the detailed description
The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.
- Conditions
- Diabetes Mellitus
- Being tested
- Acetaminophen Challenge (G6 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.
Acetaminophen Challenge (G6 CGM)Device
Evaluation of acetaminophen effect on CGM glucose sensing
| Study group | Role | What they receive |
|---|---|---|
| CGM Users | Other | Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention. Receives: Device: Acetaminophen Challenge (G6 CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interference Effect for the G6 CGM
Bias of sensor to reference measurement pre and post acetaminophen administration
Measured: 6 hrs post dose
Secondary outcomes (2)
Mean of sensor minus YSI values (bias) for various time periods
Bias calculated for pre-dose, post dose and peak post dose
Measured: 6 hrs post dose
Duration of interference effect for the G6 CGM
Length of time the inhibition effect is more than 10 mg/dL
Measured: 6 hrs post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start3 Feb 2017
- Primary completion4 Mar 2017
- Study completion4 Mar 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
- 70 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
- NCT03087877
- Sponsor's protocol ID
- PTL902020
- Status last verified
- Dec 2018
- First submitted
- 24 Feb 2017
- 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
- Evaluation of the Dexcom G6 Continuous Glucose Monitoring System With a Non-Interferent Sensor
- ClinicalTrials.gov ID
- NCT03087877
- Acronym / sponsor ID
- PTL902020
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 4 Mar 2017 (actual)
- Study completion
- 4 Mar 2017 (actual)
- First posted
- 23 Mar 2017 (actual)
- 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 objective of the study is to demonstrate effectiveness of the G6 sensor membrane, in preventing acetaminophen's interference effect on glucose sensing.
Detailed description
The interference effect of the sensor will be evaluated by comparing the bias in the glucose values exhibited from the G6 CGM system after administration of acetaminophen. Bias will be evaluated by comparing CGM values to a laboratory referenceusing venous sample measurements.
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: Acetaminophen Challenge (G6 CGM)Prospective, non-randomized, single-arm. Continuous Glucose Monitoring. Acetaminophen challenge is the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ages 18 or older
- Diagnosis of diabetes
Key exclusion criteria (3 listed)
- Pregnancy
- Known gastroparesis
- Abnormal liver function
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 |
|---|---|---|
| Acetaminophen Challenge (G6 CGM)Evaluation of acetaminophen effect on CGM glucose sensing | Device | CGM Users |
Primary outcome
Interference Effect for the G6 CGM
Time frame: 6 hrs post dose
Bias of sensor to reference measurement pre and post acetaminophen administration
2 secondary outcomes
Mean of sensor minus YSI values (bias) for various time periods
Time frame: 6 hrs post dose
Duration of interference effect for the G6 CGM
Time frame: 6 hrs post dose
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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen Challenge (G6 CGM) in people with Diabetes Mellitus, run by DexCom, Inc. at 4 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 2 inclusion and 3 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 4 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?
Interference Effect for the G6 CGM (time frame: 6 hrs post dose). 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.