Diabetes MellitusNCT04905628
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
An observational study of Diabetes Mellitus, run by DexCom, Inc. at 5 sites in United States.
Trial summary
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Dexcom CGM System
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Jul 2021to 15 Apr 2022
- Phase
- Observational
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 1. Age ≥ 18 years 2. Confirmed pregnancy 3. Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
Who may be able to join
- Age ≥ 18 years
- Confirmed pregnancy
- Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
- Willing to wear up to the required number of Systems for the total duration of study wear
- Able to follow study procedures;
- Able to speak, read, and write in English or Spanish.
Who cannot join
- Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
- Known allergy to medical-grade adhesives
- Hematocrit outside specification
- Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
- Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
- Currently using Hydroxyurea for treatment
- Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Christie Beatson, RD, CDE, CHRISTIE.BEATSON@CUANSCHUTZ.EDU
Sarit Polsky, MD
- Recruiting
Joslin Diabetes Center
Boston, Massachusetts, 02215
Julianne O'Connell, julianne.oconnell@joslin.harvard.edu
Florence Brown, MD
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Selassie Ogyaadu, selassie.ogyaadu@mssm.edu
Carol Levy, MD
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Monica Rincon, mfmresearch@ohsu.edu
Amy Valent, MD
- Recruiting
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
Nina Shelton, nshelton@sansum.org
Kristin Castorino, D.O.
About this study
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
- Conditions
- Diabetes Mellitus
- Being tested
- Dexcom CGM 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 CGM SystemDevice
Dexcom CGM System
| Study group | Role | What they receive |
|---|---|---|
| Dexcom CGM System | Dexcom CGM System Receives: Device: Dexcom CGM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexcom Continuous Glucose Monitoring (CGM) System Performance
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to 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 posted27 May 2021
- Study start8 Jul 2021
- Primary completion31 Mar 2022 (estimated)
- Study completion15 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carol Levy, MD, CDCES, Principal investigator, Icahn School of Medicine at Mount SinaiSarit Polsky,, MD, MPH, Principal investigator, Barbara Davis CenterFlorence Brown, MD, Principal investigator, Joslin Diabetes CenterKristin Castorino, DO, Principal investigator, Sansum Diabetes Research InstituteAmy Valent, DO, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905628
- Sponsor's protocol ID
- PTL-904284
- Status last verified
- Feb 2022
- First submitted
- 24 May 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 May;26(5):307-312. doi: 10.1089/dia.2023.0516. Epub 2024 Mar 1.
PubMed 38315503
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04905628
- Acronym / sponsor ID
- PTL-904284
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Jul 2021 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 15 Apr 2022 (estimated)
- First posted
- 27 May 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.
Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom CGM System | – | Device: Dexcom CGM SystemDexcom CGM System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Age ≥ 18 years 2. Confirmed pregnancy 3. Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Confirmed pregnancy
- Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
- Willing to wear up to the required number of Systems for the total duration of study wear
- Able to follow study procedures;
Key exclusion criteria (7 listed)
- Extensive skin changes/diseases that preclude wearing the required number of Systems at the proposed wear sites
- Known allergy to medical-grade adhesives
- Hematocrit outside specification
- Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
- Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
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 CGM SystemDexcom CGM System | Device | Dexcom CGM System |
Primary outcome
Dexcom Continuous Glucose Monitoring (CGM) System Performance
Time frame: 10 Days
The Dexcom Continuous Glucose Monitoring (CGM) System performance will be assessed compared to Yellow Springs Instrument (YSI) 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 21 Feb 2022.
- Derived from this study: PubMed 38315503Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 May;26(5):307-312. doi: 10.1089/dia.2023.0516. Epub 2024 Mar 1.
- 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.
Carol Levy, MD, CDCES principal investigator
Icahn School of Medicine at Mount Sinai
Sarit Polsky,, MD, MPH principal investigator
Barbara Davis Center
Florence Brown, MD principal investigator
Joslin Diabetes Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, run by DexCom, Inc. at 5 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 6 inclusion and 7 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 21 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 5 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, PTL904284@dexcom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexcom Continuous Glucose Monitoring (CGM) 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 NCT04905628, which also lists 1 linked publication.
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 21 Feb 2022.