Diabetes, GestationalNCT05492890
Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care
An observational study of Diabetes, Gestational, run by Ohio State University.
Trial summary
Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes, Gestational
- What is being tested?
- Dexcom G6
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 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 50 years
- Women only
- Adult
Study population: Women ages 18-45 who are pregnant
Who may be able to join
- Age 18-50 years
- Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
- Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
- 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
- Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
- 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
- History of severe skin allergy to adhesive products or CGM within the previous 3 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority
Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.
- 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 |
|---|---|---|
| Dexcom CGM | Continuous glucose monitoring Receives: Device: Dexcom G6 | |
| Point of care testing | Finger poke glucose measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal outcome
Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements
Measured: 9 months
Secondary outcomes (1)
Neonatal outcomes
Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment
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 posted9 Aug 2022
- Study startAug 2022 (estimated)
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 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
- NCT05492890
- Sponsor's protocol ID
- 2020H0498
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No IPD will be shared with outside investigators
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority
- ClinicalTrials.gov ID
- NCT05492890
- Acronym / sponsor ID
- 2020H0498
- Conditions
- Diabetes, Gestational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 9 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 and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexcom CGM | – | Device: Dexcom G6Continuous glucose monitoring |
| Point of care testing | – | –Finger poke glucose measure |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women ages 18-45 who are pregnant
Key inclusion criteria (5 listed)
- Age 18-50 years
- Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
- Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
- 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 (7 listed)
- Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
- 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
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 | Dexcom CGM |
Primary outcome
Maternal outcome
Time frame: 9 months
Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements
1 secondary outcome
Neonatal outcomes
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 9 Aug 2022.
- Individual participant dataSharing planned: No. No IPD will be shared with outside investigators
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, Gestational, run by Ohio State University.
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 5 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 9 Aug 2022. 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 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?
Maternal outcome (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 9 Aug 2022.