Diabetes, GestationalNCT05491954
Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance
An observational study of Diabetes, Gestational, run by Ohio State University at 1 site in United States.
Trial summary
Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Dexcom G6
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to Aug 2023
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus
Who may be able to join
- Age 18-45 years
- Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
- Planning to deliver at OSU Wexner Medical Center
- Able to understand the study, and having understood, provide written informed consent in English
Who cannot join
- Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
- Known pregestational diabetes (type 1, type 2, MODY)
- 50g GCT >200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
- Abnormal obstetrical ultrasound suspicious for major congenital abnormality
- Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
- Participation in another trial that may influence the primary outcome, without prior approval
- Participation in this trial in a prior pregnancy
- Higher order pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University Medical Center
Columbus, Ohio, 43210
Elizabeth Buschur, MD, 614-293-8045, Elizabeth.Buschur@osumc.edu
About this study
Official title: The Use of Continuous Glucose Monitors Among Women With Various Degrees of Glucose Intolerance: An Observational Cohort Study
Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.
- Conditions
- Diabetes, Gestational
- Being tested
- Dexcom G6
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6Device
Continuous glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Euglycemic | Women who pass a 50g GCT with 1-hour glucose <135 mg/dL Receives: Device: Dexcom G6 | |
| Possible glucose intolerance | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 0/4 abnormal values on a 100g oral glucose tolerance test (OGTT) by Carpenter-Coustan values Receives: Device: Dexcom G6 | |
| Confirmed glucose intolerance | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 1/4 abnormal values on 100g GTT test by Carpenter-Coustan values Receives: Device: Dexcom G6 | |
| Gestational Diabetes Mellitus | Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have ≥2/4 abnormal values on 100g GTT test by Carpenter-Coustan values (Table 1), meeting criteria for GDM Receives: Device: Dexcom G6 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycemic control over late gestation as measured by A1c
Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery
Measured: 9 months
Secondary outcomes (1)
The number of neonatal hypoglycemic episodes
Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Aug 2022
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes, GestationalStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Buschur, MD, Principal investigator, tOSU Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491954
- Sponsor's protocol ID
- 2021H0009
- Status last verified
- Sep 2022
- First submitted
- 5 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Glucose Monitors Among Women With Various Degrees of Glucose Intolerance: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05491954
- Acronym / sponsor ID
- 2021H0009
- Conditions
- Diabetes, Gestational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 8 Aug 2022 (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.
Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Euglycemic | – | Device: Dexcom G6Women who pass a 50g GCT with 1-hour glucose <135 mg/dL |
| Possible glucose intolerance | – | Device: Dexcom G6Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 0/4 abnormal values on a 100g oral glucose tolerance test (OGTT) by Carpenter-Coustan values |
| Confirmed glucose intolerance | – | Device: Dexcom G6Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have 1/4 abnormal values on 100g GTT test by Carpenter-Coustan values |
| Gestational Diabetes Mellitus | – | Device: Dexcom G6Women who fail a 50g GCT (1-hour glucose >135 mg/dL) and have ≥2/4 abnormal values on 100g GTT test by Carpenter-Coustan values (Table 1), meeting criteria for GDM |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus
Key inclusion criteria (4 listed)
- Age 18-45 years
- Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
- Planning to deliver at OSU Wexner Medical Center
- Able to understand the study, and having understood, provide written informed consent in English
Key exclusion criteria (8 listed)
- Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
- Known pregestational diabetes (type 1, type 2, MODY)
- 50g GCT >200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
- Abnormal obstetrical ultrasound suspicious for major congenital abnormality
- Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
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 G6Continuous glucose monitoring | Device | Confirmed glucose intolerance, Euglycemic, Gestational Diabetes Mellitus, Possible glucose intolerance |
Primary outcome
Changes in glycemic control over late gestation as measured by A1c
Time frame: 9 months
Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery
1 secondary outcome
The number of neonatal hypoglycemic episodes
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No. No IPD will be available to other researchers
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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.
Elizabeth Buschur, MD principal investigator
tOSU Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational, run by Ohio State 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 8 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 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Buschur, MD (614-293-8045, Elizabeth.Buschur@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycemic control over late gestation as measured by A1c (time frame: 9 months). 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 21 Sep 2022.