Postpartum Gestational Diabetes MellitusPPCMSNCT06057805
The PPCGMS Intervention After GDM Trial
A study testing Blinded Dexcom G7 CGM in people with Postpartum Gestational Diabetes Mellitus, run by Woman's at 1 site in United States.
Trial summary
Among women who experience glucose abnormalities during pregnancy, screening during the postpartum period offers a window of opportunity for early identification of diabetes and prediabetes. 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
- Postpartum Gestational Diabetes Mellitus
- What is being tested?
- Blinded Dexcom G7 CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2024to 16 Oct 2024
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- diagnosis of gestational diabetes during recent pregnancy (4-24 weeks)
- age 18 or older.
- written informed consent
Who cannot join
- pregestational diabetes (type 1 or type 2)
- include known known skin adhesive allergy which would prevent subject from wearing a CGM,
- history of bariatric surgery or other surgeries that induce malabsorption
- long-term use (>2 weeks) of systemic steroids during the testing interval
- inability or refusal to comply with protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can "Continuous Glucose Monitors" (CGMS) Improve Postpartum (PP) Gestational Diabetes (GDM) Screening for Diabetes?
Among women who experience glucose abnormalities during pregnancy, screening during the postpartum period offers a window of opportunity for early identification of diabetes and prediabetes. The rates of postpartum type 2 diabetes (T2D) screening with an OGTT for women with GDM are not optimal given the majority of women with GDM fail to return for postpartum glucose testing. Continuous glucose monitoring (CGM) systems have been recognized as an ideal method of monitoring glycemic control in diabetic patients. CGM has been used in diabetic patients primarily as a management tool allowing a more acceptable and reliable glucose reading and control than self-monitoring of blood glucose (SMBG). There is a need to improve diabetes testing after childbirth in women who experienced gestational diabetes. This will allow investigators to target their efforts to improve the early diagnosis and treatment of diabetes following GDM. No studies conducted to date have not comprehensively examined whether CGM after delivery can be used in women with a recent history to predict their risk of diabetes. This research study is being done to assess the acceptability, feasibility, and accuracy of using a glucose sensor (also known as a continuous glucose monitor or CGM) after childbirth as a diagnostic test that can help identify women who are at risk of developing diabetes after having gestational diabetes and explore its correlation to the standard postpartum oral glucose tolerance test as well as a HbA1c and fructosamine test.
Read the detailed description
Given the damaging effect of prolonged undetected hyperglycemia, prevention and early diagnosis of T2D is cost-saving and of public health importance. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 4-16 weeks after delivery, but this is burdensome and most patients are non-compliant. This study will use a CGM worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test as well as a HbA1c and fructosamine test. This is a single site study from patients with recent GDM that attended the diabetes clinic at Woman's Hospital. This is a prospective observational study of fifty postpartum women with a recent GDM pregnancy. The research team plans to enroll 50 participants aged 18 years or older into the study. Participation in the study is expected to last up to 10 days during the postpartum interval. Study procedures include; 1) consent and screening; and 2) sensor placement and download after 10 days of wear postpartum during which an OGTT, fructosamine and HbA1c test will be administered. All participants will be requested to return at 4-16 weeks postpartum for a 75 gm 2-hour OGTT as part of standard care after gestational diabetes. Study participants with a history of GDM will be enrolled to use a blinded continuous glucose monitor (Dexcom G7). All CGM data will be masked and therefore not available to participants, clinicians, or researchers in real time. Participants otherwise will receive standard clinical care. All participants will be recruited from the Woman's Hospital Diabetes Clinic or from the maternal fetal medicine practice referring to the clinic. Subjects who wish to participate will provide written informed consent. The Woman's Hospital Institutional Review Board (WHIRB) will have approved both the protocol and consent. All participants will undergo a verbal screen, and if they are eligible and sign a medical release form, their medical records will be obtained to confirm their medical history. After consenting, demographic data, gravidity, parity, and body mass index (BMI) will obtained. The patient's physician will be notified of participation in the study and have access to the laboratory result.
- Conditions
- Postpartum Gestational Diabetes Mellitus
- Being tested
- Blinded Dexcom G7 CGM
- Keywords
- postpartum, continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blinded Dexcom G7 CGMDevice
Also called Blinded continuous glucose monitor Dexcom G7
CGM that records blood glucose but not visible to patient or provider in real time
| Study group | Role | What they receive |
|---|---|---|
| Blinded CGM | Experimental | Blinded continuous glucose monitor Dexcom G7 Receives: Device: Blinded Dexcom G7 CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGM metric of mean glucose compared to OGTT result
CGM metric of mean glucose will be compared to standard 75-gram postpartum OGTT result
Measured: up to 10 days
Secondary outcomes (8)
CGM variability metric of time in range will be compared to OGTT result
CGM variability metric of time in range will be compared to standard 75-gram postpartum OGTT result
Measured: up to 10 days
CGM variability measure MAGE will be compared to be compared to OGTT result
CGM variability measure w MAGE will be compared to standard 75-gram postpartum OGTT result
Measured: up to 10 days
CGM metric of mean glucose compared to hemoglobin A1C result
CGM metric of mean glucose will be compared to hemoglobin A1C result result
Measured: up to 10 days
CGM variability metric of time in range will be compared to hemoglobin A1C test
CGM variability metric of time in range will be compared to hemoglobin A1C test result
Measured: up to 10 days
CGM variability measure MAGE will be compared to hemoglobin A1C test
CGM variability measure w MAGE will be compared to hemoglobin A1C test result
Measured: up to 10 days
CGM metric of mean glucose compared to fructosamine test
CGM metric of mean glucose will be compared to fructosamine test result
Measured: up to 10 days
CGM variability metric of time in range will be compared to fructosamine test
CGM variability metric of time in range will be compared to fructosamine test result
Measured: up to 10 days
CGM variability measure MAGE will be compared to fructosamine test
CGM variability measure w MAGE will be compared to standard fructosamine test result
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start6 Feb 2024
- Primary completion16 Oct 2024
- Study completion16 Oct 2024
Why it stopped: data was sufficient to determine outcome
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 Postpartum Gestational 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Blinded continuous glucose monitor will be compared with routine blood testing postpartum
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Woman's
- Sponsor type
- University, hospital or other
- Collaborators
- DexCom, Inc.
- Responsible party
- Sponsor
- Investigators
- Karen Elkind-Hirsch, PhD, Principal investigator, Woman's Hospital, Louisiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057805
- Sponsor's protocol ID
- RP23-010
- Acronym
- PPCMS
- Status last verified
- Oct 2024
- First submitted
- 11 Sep 2023
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The proposed study will involve a small sample (50 subjects) recruited from the Diabetes center at Woman's Hospital. Despite the removal of all identifiers, it would be difficult if not impossible to protect the identity of of all subjects. So even though the final data set will be stripped of identifiers prior to release for sharing, the investigators assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the de-identified data and associated documentation available to users only under a dat-sharing agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
Publications
Elkind-Hirsch KE, Armatta ML, Hames KC, Veillon EW Jr. Continuous glucose monitoring predicts glycemic status in postpartum women with a recent history of gestational diabetes. Expert Rev Med Devices. 2026 Jan;23(1):99-105. doi: 10.1080/17434440.2025.2607631. Epub 2025 Dec 26.
PubMed 41422557
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can "Continuous Glucose Monitors" (CGMS) Improve Postpartum (PP) Gestational Diabetes (GDM) Screening for Diabetes?
- ClinicalTrials.gov ID
- NCT06057805
- Acronym / sponsor ID
- PPCMS / RP23-010
- Conditions
- Postpartum Gestational Diabetes Mellitus
- Keywords
- postpartum, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: data was sufficient to determine outcome
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Woman'sUniversity, hospital or other
- Collaborators
- DexCom, Inc.
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 16 Oct 2024 (actual)
- Study completion
- 16 Oct 2024 (actual)
- First posted
- 28 Sep 2023 (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.
Among women who experience glucose abnormalities during pregnancy, screening during the postpartum period offers a window of opportunity for early identification of diabetes and prediabetes. The rates of postpartum type 2 diabetes (T2D) screening with an OGTT for women with GDM are not optimal given the majority of women with GDM fail to return for postpartum glucose testing. Continuous glucose monitoring (CGM) systems have been recognized as an ideal method of monitoring glycemic control in diabetic patients. CGM has been used in diabetic patients primarily as a management tool allowing a more acceptable and reliable glucose reading and control than self-monitoring of blood glucose (SMBG). There is a need to improve diabetes testing after childbirth in women who experienced gestational diabetes. This will allow investigators to target their efforts to improve the early diagnosis and treatment of diabetes following GDM. No studies conducted to date have not comprehensively examined whether CGM after delivery can be used in women with a recent history to predict their risk of diabetes. This research study is being done to assess the acceptability, feasibility, and accuracy of using a glucose sensor (also known as a continuous glucose monitor or CGM) after childbirth as a diagnostic test that can help identify women who are at risk of developing diabetes after having gestational diabetes and explore its correlation to the standard postpartum oral glucose tolerance test as well as a HbA1c and fructosamine test.
Detailed description
Given the damaging effect of prolonged undetected hyperglycemia, prevention and early diagnosis of T2D is cost-saving and of public health importance. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 4-16 weeks after delivery, but this is burdensome and most patients are non-compliant. This study will use a CGM worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test as well as a HbA1c and fructosamine test. This is a single site study from patients with recent GDM that attended the diabetes clinic at Woman's Hospital. This is a prospective observational study of fifty postpartum women with a recent GDM pregnancy. The research team plans to enroll 50 participants aged 18 years or older into the study. Participation in the study is expected to last up to 10 days during the postpartum interval. Study procedures include; 1) consent and screening; and 2) sensor placement and download after 10 days of wear postpartum during which an OGTT, fructosamine and HbA1c test will be administered. All participants will be requested to return at 4-16 weeks postpartum for a 75 gm 2-hour OGTT as part of standard care after gestational diabetes. Study participants with a history of GDM will be enrolled to use a blinded continuous glucose monitor (Dexcom G7). All CGM data will be masked and therefore not available to participants, clinicians, or researchers in real time. Participants otherwise will receive standard clinical care. All participants will be recruited from the Woman's Hospital Diabetes Clinic or from the maternal fetal medicine practice referring to the clinic. Subjects who wish to participate will provide written informed consent. The Woman's Hospital Institutional Review Board (WHIRB) will have approved both the protocol and consent. All participants will undergo a verbal screen, and if they are eligible and sign a medical release form, their medical records will be obtained to confirm their medical history. After consenting, demographic data, gravidity, parity, and body mass index (BMI) will obtained. The patient's physician will be notified of participation in the study and have access to the laboratory result.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Blinded continuous glucose monitor will be compared with routine blood testing postpartum
| Arm | Type | Receives |
|---|---|---|
| Blinded CGM | Experimental | Device: Blinded Dexcom G7 CGMBlinded continuous glucose monitor Dexcom G7 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosis of gestational diabetes during recent pregnancy (4-24 weeks)
- age 18 or older.
- written informed consent
Key exclusion criteria (5 listed)
- pregestational diabetes (type 1 or type 2)
- include known known skin adhesive allergy which would prevent subject from wearing a CGM,
- history of bariatric surgery or other surgeries that induce malabsorption
- long-term use (>2 weeks) of systemic steroids during the testing interval
- inability or refusal to comply with protocol
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 |
|---|---|---|
| Blinded Dexcom G7 CGMAlso: Blinded continuous glucose monitor Dexcom G7CGM that records blood glucose but not visible to patient or provider in real time | Device | Blinded CGM |
Primary outcome
CGM metric of mean glucose compared to OGTT result
Time frame: up to 10 days
CGM metric of mean glucose will be compared to standard 75-gram postpartum OGTT result
8 secondary outcomes
CGM variability metric of time in range will be compared to OGTT result
Time frame: up to 10 days
CGM variability measure MAGE will be compared to be compared to OGTT result
Time frame: up to 10 days
CGM metric of mean glucose compared to hemoglobin A1C result
Time frame: up to 10 days
CGM variability metric of time in range will be compared to hemoglobin A1C test
Time frame: up to 10 days
CGM variability measure MAGE will be compared to hemoglobin A1C test
Time frame: up to 10 days
CGM metric of mean glucose compared to fructosamine test
Time frame: up to 10 days
CGM variability metric of time in range will be compared to fructosamine test
Time frame: up to 10 days
CGM variability measure MAGE will be compared to fructosamine test
Time frame: up to 10 days
Results and safety
The study was stopped early (reason given: data was sufficient to determine outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Derived from this study: PubMed 41422557Elkind-Hirsch KE, Armatta ML, Hames KC, Veillon EW Jr. Continuous glucose monitoring predicts glycemic status in postpartum women with a recent history of gestational diabetes. Expert Rev Med Devices. 2026 Jan;23(1):99-105. doi: 10.1080/17434440.2025.2607631. Epub 2025 Dec 26.
- Individual participant dataSharing planned: No. The proposed study will involve a small sample (50 subjects) recruited from the Diabetes center at Woman's Hospital. Despite the removal of all identifiers, it would be difficult if not impossible to protect the identity of of all subjects. So even though the final data set will be stripped of identifiers prior to release for sharing, the investigators assume that there remains the possibility of deductive disclosure of subjects with unusual characteristics. Thus, the investigators will make the de-identified data and associated documentation available to users only under a dat-sharing agreement that provides for 1) a commitment to using the data only for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroying or returning the data after analyses are completed.
Related trials for Postpartum Gestational Diabetes Mellitus
RecruitingEarly Phase 1
Metformin for the Treatment of Microvascular Dysfunction After Gestational Diabetes
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A Randomized Trial to Reduce Blood Pressure at One Year Postpartum After Preeclampsia
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Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot
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A Randomized Controlled Trial of Diabetes Screening Immediately Postpartum (DIP) and Follow Up PP CARE
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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.
Karen Elkind-Hirsch, PhD principal investigator
Woman's Hospital, Louisiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blinded Dexcom G7 CGM in people with Postpartum Gestational Diabetes Mellitus, run by Woman's 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 18 Oct 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 was stopped early (reason given: data was sufficient to determine outcome). Results are not available in the source record.
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?
CGM metric of mean glucose compared to OGTT result (time frame: up to 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 NCT06057805, 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 18 Oct 2024.