DiabetesNCT03935191
Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
An observational study of Diabetes, run by DexCom, Inc..
Trial summary
The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period 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
- What is being tested?
- Dexcom CGM System
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2019to 31 May 2019
- 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. Currently in the 2nd or 3rd trimester of pregnancy; 3. Diagnosis of GDM, T1DM, or T2DM;
Who may be able to join
- Age ≥ 18 years;
- Currently in the 2nd or 3rd trimester of pregnancy;
- Diagnosis of GDM, T1DM, or T2DM;
- Willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
- 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 devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Known allergy to medical-grade adhesives;
- Hematocrit of < 30%;
- Prescribed tocolytic drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications, including, but not limited to, pre-eclampsia or HELLP syndrome (hemolysis, elevated liver enzymes, and a low platelet count) during current pregnancy;
- Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period;
- Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period;
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- Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.);
- Working for a competitive medical device company or having an immediate family member or person living within the same household who works for such a company (e.g., Medtronic, GlySens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, and Ascencia/POCTech);
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose excessive risk to study staff handling venous blood samples (e.g., known history of HIV or Hepatitis B or C).
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.
Read the detailed description
Primary Study Objective:
To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.
Secondary Study Objective:
To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
- Conditions
- Diabetes
- 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 |
|---|---|---|
| Group | Device: 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 G6 CGM Accuracy
Accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.
Measured: 10 days
Secondary outcomes (1)
Dexcom G6 CGM Safety
Assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
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 posted2 May 2019
- Study start1 May 2019 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DexCom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stayce Beck, Study director, DexCom, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03935191
- Sponsor's protocol ID
- PTL-903652
- Status last verified
- Apr 2019
- First submitted
- 30 Apr 2019
- Last updated
- 2 May 2019
- 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 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of the Dexcom G6 Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03935191
- Acronym / sponsor ID
- PTL-903652
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- DexCom, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 May 2019 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 2 May 2019 (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 purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.
Detailed description
Primary Study Objective:
To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.
Secondary Study Objective:
To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | – | Device: Dexcom CGM SystemDevice: Dexcom 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. Currently in the 2nd or 3rd trimester of pregnancy; 3. Diagnosis of GDM, T1DM, or T2DM;
Key inclusion criteria (6 listed)
- Age ≥ 18 years;
- Currently in the 2nd or 3rd trimester of pregnancy;
- Diagnosis of GDM, T1DM, or T2DM;
- Willing to avoid insulin injections or wear an insulin pump insertion set within 3 inches from the sensor site;
- Able to follow study procedures;
Key exclusion criteria (9 listed)
- Extensive skin changes/diseases that preclude wearing the required number of devices on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites;
- Known allergy to medical-grade adhesives;
- Hematocrit of < 30%;
- Prescribed tocolytic drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications, including, but not limited to, pre-eclampsia or HELLP syndrome (hemolysis, elevated liver enzymes, and a low platelet count) 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 | Group |
Primary outcome
Dexcom G6 CGM Accuracy
Time frame: 10 days
Accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus.
1 secondary outcome
Dexcom G6 CGM Safety
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 2 May 2019.
- 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.
Stayce Beck study director
DexCom, Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by DexCom, Inc..
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 9 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 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Cynthia Makady (858-200-0272, cmakady@dexcom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexcom G6 CGM Accuracy (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 2 May 2019.