Diabetes MellitusNCT04645641
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
A study testing Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by DexCom, Inc. at 4 sites in United States.
Trial summary
Evaluation of the Safety and Effectiveness of the Dexcom 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?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 12 Oct 2020to Dec 2020
- 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
- Willing to wear the required number of Systems for the total duration of study wear
- Willing to participate in Clinic Session(s) during study wear
Who cannot join
- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification
- ≥ 18 years of age:
- Male: 36.0%;
Show all 11Show fewer
- Female: 33.0%;
- 13-17 years of age: 35.0%;
- 7 years - 12 years of age: 32.0%;
- End stage renal disease and currently managed by dialysis or anticipating initiating dialysis during the study wear period
- Required or scheduled to have a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the study wear period
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Barbara Davis Center
Aurora, Colorado, 80045
- Recruiting
AMCR Institute
Escondido, California, 92025
- Recruiting
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 82404
- Recruiting
Endeavor Clinical Trials
San Antonio, Texas, 78229
About this study
Official title: Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Read the detailed description
The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
- Conditions
- Diabetes Mellitus
- Being tested
- Continuous Glucose Monitoring System
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDevice
Continuous Glucose Monitoring System
| Study group | Role | What they receive |
|---|---|---|
| CGM Users | Active comparator | Glucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement. Receives: Device: Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Performance
System Performance will be characterized with respect to comparator venous plasma measurements.
Measured: 10 days
Secondary outcomes (1)
System Related Adverse Device Effects
System will be characterized by Adverse Device Effects experienced by study participants
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 posted27 Nov 2020
- Study start12 Oct 2020
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04645641
- Sponsor's protocol ID
- PTL-904120
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 27 Nov 2020
- 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 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM)
- ClinicalTrials.gov ID
- NCT04645641
- Acronym / sponsor ID
- PTL-904120
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Nov 2020 (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.
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Detailed description
The objective of the study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
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 | Active comparator | Device: Continuous Glucose Monitoring SystemGlucose challenge during clinic sessions to assess performance of CGM compared to comparator measurement. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Ages 2 or older
- Diagnosis of Type 1 diabetes or Type 2 diabetes
- Willing to wear the required number of Systems for the total duration of study wear
- Willing to participate in Clinic Session(s) during study wear
Key exclusion criteria (11 listed)
- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude wearing the sensor(s) on skin
- Known allergy to medical-grade adhesives
- Pregnancy
- Hematocrit outside specification
- ≥ 18 years of age:
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 |
|---|---|---|
| Continuous Glucose Monitoring SystemContinuous Glucose Monitoring System | Device | CGM Users |
Primary outcome
System Performance
Time frame: 10 days
System Performance will be characterized with respect to comparator venous plasma measurements.
1 secondary outcome
System Related Adverse Device Effects
Time frame: 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System 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 4 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stayce Beck, PhD, MPH (858-203-6454, stayce.beck@dexcom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
System Performance (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 27 Nov 2020.