Diabetes MellitusNCT04794478
Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
A study testing Dexcom Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by DexCom, Inc. at 12 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?
- Dexcom Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 12 sitesUnited States
- Study dates
- 19 Feb 2021to 31 Oct 2021
- 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
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Barbara Davis Center
Aurora, Colorado, 80045
Joslin Diabetes Center
Boston, Massachusetts, 02215
UVA Center for Diabetes Technology
Charlottesville, Virginia, 22903
ProSciento
Chula Vista, California, 91911
AMCR Institute
Escondido, California, 92025
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 82404
Advanced Research
Ogden, Utah, 84405
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229
Diabetes & Glandular Disease Clinic, P.A.
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78229
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
Evaluation of the Safety and Effectiveness of the Dexcom Glucose Monitoring (CGM) System
Read the detailed description
The objective of this study is to establish performance of the Dexcom CGM System (System) in comparison to a blood glucose comparator method.
- Conditions
- Diabetes Mellitus
- Being tested
- Dexcom 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.
Dexcom Continuous Glucose Monitoring SystemDevice
Dexcom 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: Dexcom Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexcom Continuous Glucose Monitoring System Performance
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements
Measured: 10 days
Secondary outcomes (1)
System Related Adverse Device Effects
The Dexcom Continuous Glucose Monitoring (CGM) 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 posted12 Mar 2021
- Study start19 Feb 2021
- Primary completion9 Aug 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 482 participants (actual)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794478
- Sponsor's protocol ID
- PTL-903880
- Status last verified
- Feb 2022
- First submitted
- 2 Mar 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Laffel LM, Bailey TS, Christiansen MP, Reid JL, Beck SE. Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 Jul;17(4):962-967. doi: 10.1177/19322968221091816. Epub 2022 Apr 25.
PubMed 35466707Garg SK, Kipnes M, Castorino K, Bailey TS, Akturk HK, Welsh JB, Christiansen MP, Balo AK, Brown SA, Reid JL, Beck SE. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):373-380. doi: 10.1089/dia.2022.0011. Epub 2022 Feb 21.
PubMed 35157505
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System
- ClinicalTrials.gov ID
- NCT04794478
- Acronym / sponsor ID
- PTL-903880
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 482 participants (actual)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 12 Mar 2021 (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 this 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: Dexcom 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 |
|---|---|---|
| Dexcom Continuous Glucose Monitoring SystemDexcom Continuous Glucose Monitoring System | Device | CGM Users |
Primary outcome
Dexcom Continuous Glucose Monitoring System Performance
Time frame: 10 days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to the Yellow Springs Instrument (YSI) comparator venous plasma measurements
1 secondary outcome
System Related Adverse Device Effects
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 18 Feb 2022.
- Derived from this study: PubMed 35466707Laffel LM, Bailey TS, Christiansen MP, Reid JL, Beck SE. Accuracy of a Seventh-Generation Continuous Glucose Monitoring System in Children and Adolescents With Type 1 Diabetes. J Diabetes Sci Technol. 2023 Jul;17(4):962-967. doi: 10.1177/19322968221091816. Epub 2022 Apr 25.
- Derived from this study: PubMed 35157505Garg SK, Kipnes M, Castorino K, Bailey TS, Akturk HK, Welsh JB, Christiansen MP, Balo AK, Brown SA, Reid JL, Beck SE. Accuracy and Safety of Dexcom G7 Continuous Glucose Monitoring in Adults with Diabetes. Diabetes Technol Ther. 2022 Jun;24(6):373-380. doi: 10.1089/dia.2022.0011. Epub 2022 Feb 21.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexcom Continuous Glucose Monitoring System in people with Diabetes Mellitus, run by DexCom, Inc. at 12 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: finished, as of the sponsor's last update on 18 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
Dexcom Continuous Glucose Monitoring 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?
On the ClinicalTrials.gov record for NCT04794478, which also lists 2 linked publications.
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 18 Feb 2022.