Gestational DiabetesNCT04605497
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
A study testing Continuous glucose monitoring (CGM) and Self-Capillary Blood Glucose Monitoring (SCBG) in people with Gestational Diabetes, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Continuous glucose monitoring (CGM) and Self-Capillary Blood Glucose Monitoring (SCBG)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Feb 2021to 31 Dec 2023
- 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 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55 years
- Singleton pregnancy ≥20 weeks gestation
- Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
- Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver
Who cannot join
- Chronic immunosuppression
- Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
- Known allergy to medical grade adhesives
- Pre-gestational diabetes
- Multifetal gestation
- Current alcohol or illicit drug use
- Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range
The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes
- Conditions
- Gestational Diabetes
- Being tested
- Continuous glucose monitoring (CGM), Self-Capillary Blood Glucose Monitoring (SCBG)
- Keywords
- Female, pregnancy, gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring (CGM)Diagnostic test
Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission \& discharge + additional 10 days during postpartum period
Self-Capillary Blood Glucose Monitoring (SCBG)Diagnostic test
Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually. Receives: Diagnostic Test: Continuous glucose monitoring (CGM) |
| Referent Arm | Other | Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks. Receives: Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average time-in-range over a 24 hour period
Measured: From enrollment to10 days after discharge from hospital following delivery
Secondary outcomes (2)
Average time-in-range during waking hours
Measured: From enrollment to10 days after discharge from hospital following delivery
Average time-in-range while asleep
Measured: From enrollment to10 days after discharge from hospital following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start11 Feb 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Principal investigator, Amy Miyoshi Valent, Oregon Health and Science University
- Investigators
- Amy Valent, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605497
- Sponsor's protocol ID
- STUDY00021775
- Status last verified
- May 2024
- First submitted
- 22 Oct 2020
- Last updated
- 31 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range
- ClinicalTrials.gov ID
- NCT04605497
- Acronym / sponsor ID
- STUDY00021775
- Conditions
- Gestational Diabetes
- Keywords
- Female, pregnancy, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 28 Oct 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.
The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Diagnostic Test: Continuous glucose monitoring (CGM)Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually. |
| Referent Arm | Other | Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG)Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-55 years
- Singleton pregnancy ≥20 weeks gestation
- Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
- Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver
Key exclusion criteria (7 listed)
- Chronic immunosuppression
- Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
- Known allergy to medical grade adhesives
- Pre-gestational diabetes
- Multifetal gestation
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 (CGM)Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission \& discharge + additional 10 days during postpartum period | Diagnostic test | Intervention Arm |
| Self-Capillary Blood Glucose Monitoring (SCBG)Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear | Diagnostic test | Referent Arm |
Primary outcome
Average time-in-range over a 24 hour period
Time frame: From enrollment to10 days after discharge from hospital following delivery
2 secondary outcomes
Average time-in-range during waking hours
Time frame: From enrollment to10 days after discharge from hospital following delivery
Average time-in-range while asleep
Time frame: From enrollment to10 days after discharge from hospital following delivery
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 May 2024.
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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.
Amy Valent principal investigator
Oregon Health and Science University
1 site 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 (CGM) and Self-Capillary Blood Glucose Monitoring (SCBG) in people with Gestational Diabetes, run by Oregon Health and Science University at 1 site 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 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: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Average time-in-range over a 24 hour period (time frame: From enrollment to10 days after discharge from hospital following delivery). 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 May 2024.