Gestational DiabetesGDM-MOMSNCT02530866
Intensive Management for Gestational Diabetes
A study testing Lower glycemic targets in people with Gestational Diabetes, run by University of Oklahoma at 1 site in United States.
Trial summary
This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Lower glycemic targets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Mar 2018
- 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
- No healthy volunteers
- Adult
Who may be able to join
- maternal age between 18-45 years
- singleton birth
- planned delivery at OU Medical Center
- GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
- one hour GCT >200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
- pre-pregnancy BMI ≥26 kg/m2.
Who cannot join
- maternal tobacco use
- planned delivery prior to 34 weeks of gestation
- significant fetal anomalies
- chronic hypertension requiring medication
- other vascular disease
- known renal disease with a baseline serum creatinine >1.5 mg/dL
Show all 10Show fewer
- maternal rheumatologic disorders requiring medication
- maternal human immunodeficiency virus (HIV) or hepatitis
- as the specimen storage facility is not accredited to handle such samples
- steroid use within 7 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
About this study
Official title: Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes
This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.
Read the detailed description
The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.
In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.
- Conditions
- Gestational Diabetes
- Being tested
- Lower glycemic targets
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower glycemic targetsOther
Women will be randomized to either standard or lower glycemic targets.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | Active comparator | Women in this arm will target fasting blood glucose values <95 mg/dL and 1 hour post-prandial values <140 mg/dL Receives: Other: Lower glycemic targets |
| Intensive therapy | Experimental | Women in the arm will target fasting blood glucose values <90 mg/dL and 1 hour post-prandial values <120 mg/dL. Receives: Other: Lower glycemic targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline maternal glycemia at 32-36 weeks gestation
Women will undergo CGM for 5 days at both the first study visit (12-32 weeks) and again at the second study visit (32-36 weeks). Our primary outcome between women randomized to either SC or IT will compare mean 24-hour blood glucose levels as assessed by continuous glucose monitor at the 2nd study visit, which will occur between 32-36 weeks of gestation. Investigators hypothesize that women randomized to the IT group will have a 10 mg/dL lower mean 24-hour glucose as assessed by continuous glucose monitor when compared to women in the SC group. Investigators will also assess the prevalence of maternal hypoglycemia by comparing the amount of time with maternal blood glucose values <60 mg/dL between groups.
Measured: 5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)
Secondary outcomes (8)
Neonatal body composition
Total body composition will compared among infants of mothers randomized to either SC and IT using air-displacement plethysmography (ADP).
Measured: At birth
Cytokine measurements
Maternal and cord blood levels
Measured: 20-30 weeks of gestation and 32-36 weeks of gestation
Physical activity
Investigators will utilize the Actiwatch Spectrum Pro (Phillips Healthcare, Pittsburgh, PA) for assessment of both sleep and physical activity in women . Subjects will wear this device on their wrist at baseline and again at the 32-36 week follow-up visit. The Actiwatch monitoring periods are designed to coincide with the periods of CGM monitoring.
Measured: 9 months
Sleep assessments
Investigators will utilize the Actiwatch Spectrum Pro (Phillips Healthcare, Pittsburgh, PA) for assessment of both sleep and physical activity in women . Subjects will wear this device on their wrist at baseline and again at the 32-36 week follow-up visit. The Actiwatch monitoring periods are designed to coincide with the periods of CGM monitoring.
Measured: 9 months
Patient questionnaires
In order to help investigators understand the personal factors that lead to better glycemic control, patients will complete questionnaires regarding issues such as sleep, exercise, views about weight gain, mood, and stress levels.
Measured: 9 months
Lipid measurements
Measured: 20-30 weeks of gestation and 32-36 weeks of gestation
Glucose measurements
Measured: 20-30 weeks of gestation and 32-36 weeks of gestation
Lipid profile measurements
Measured: 20-30 weeks of gestation and 32-36 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionMar 2018
- Study completionMar 2018
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 Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Pierce, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530866
- Sponsor's protocol ID
- 5446
- Acronym
- GDM-MOMS
- Status last verified
- Mar 2020
- First submitted
- 10 Aug 2015
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Scifres CM, Mead-Harvey C, Nadeau H, Reid S, Pierce S, Feghali M, Myers D, Fields D, Stoner JA. Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Am J Obstet Gynecol MFM. 2019 Nov;1(4):100050. doi: 10.1016/j.ajogmf.2019.100050. Epub 2019 Sep 27.
PubMed 33345840
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Clinical Pilot Trial of Intensive Management for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT02530866
- Acronym / sponsor ID
- GDM-MOMS / 5446
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 21 Aug 2015 (estimated)
- 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.
This is a randomized clinical pilot trial designed to assess the feasibility of randomizing obese women with GDM to lower glycemic thresholds compared to standard care. Maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration will also be compared between groups.
Detailed description
The investigators will randomize 60 obese pregnant women with a new diagnosis of gestational diabetes using the Carpenter-Coustan criteria in a 1:1 fashion to either standard care or intensive therapy. Subjects will be randomized to either standard care or intensive therapy at the first study visit, which will occur between 12-32 weeks of gestation after they have completed their gestational diabetes testing. Neither patients nor their providers will be blinded to patient study group. All women will receive standard nutritional counseling at the time of diagnosis, and they will also be treated with either glyburide or insulin as dictated by standard care. Women will return for a second study visit between 32-36 weeks of gestation to assess the impact of their glycemic target groups on overall glycemic control. The investigators will also collect information on the type and dose of each medication required to maintain glycemic control in women randomized to either standard care or intensive therapy.
In addition to standard glucose monitoring 4x/day (fasting and one-hour post breakfast, lunch, and dinner), the investigators will utilize blinded continuous glucose monitors (iPro, Medtronic) at each study visit. Because women with GDM are receiving active management of their blood sugars and dietary counseling, the investigators will assess CGM for 5 consecutive days both at study enrollment and again between 32-36 weeks. Study participants will complete food diaries during their CGM monitoring to correlate food intake with glycemic variation. The investigators will also compare maternal and cord blood metabolic profiles, neonatal body composition, and maternal sleep quality and duration between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | Active comparator | Other: Lower glycemic targetsWomen in this arm will target fasting blood glucose values <95 mg/dL and 1 hour post-prandial values <140 mg/dL |
| Intensive therapy | Experimental | Other: Lower glycemic targetsWomen in the arm will target fasting blood glucose values <90 mg/dL and 1 hour post-prandial values <120 mg/dL. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- maternal age between 18-45 years
- singleton birth
- planned delivery at OU Medical Center
- GDM diagnosed between 12-32 weeks' gestation by either a 50 gram
- one hour GCT >200 mg/dL or two or more abnormal values on a 100 gram OGTT using the Carpenter-Coustan criteria
Key exclusion criteria (10 listed)
- maternal tobacco use
- planned delivery prior to 34 weeks of gestation
- significant fetal anomalies
- chronic hypertension requiring medication
- other vascular disease
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 |
|---|---|---|
| Lower glycemic targetsWomen will be randomized to either standard or lower glycemic targets. | Other | Intensive therapy, Standard care |
Primary outcome
Change in baseline maternal glycemia at 32-36 weeks gestation
Time frame: 5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)
Women will undergo CGM for 5 days at both the first study visit (12-32 weeks) and again at the second study visit (32-36 weeks). Our primary outcome between women randomized to either SC or IT will compare mean 24-hour blood glucose levels as assessed by continuous glucose monitor at the 2nd study visit, which will occur between 32-36 weeks of gestation. Investigators hypothesize that women randomized to the IT group will have a 10 mg/dL lower mean 24-hour glucose as assessed by continuous glucose monitor when compared to women in the SC group. Investigators will also assess the prevalence of maternal hypoglycemia by comparing the amount of time with maternal blood glucose values <60 mg/dL between groups.
8 secondary outcomes
Neonatal body composition
Time frame: At birth
Cytokine measurements
Time frame: 20-30 weeks of gestation and 32-36 weeks of gestation
Physical activity
Time frame: 9 months
Sleep assessments
Time frame: 9 months
Patient questionnaires
Time frame: 9 months
Lipid measurements
Time frame: 20-30 weeks of gestation and 32-36 weeks of gestation
Glucose measurements
Time frame: 20-30 weeks of gestation and 32-36 weeks of gestation
Lipid profile measurements
Time frame: 20-30 weeks of gestation and 32-36 weeks of gestation
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 6 Mar 2020.
- Derived from this study: PubMed 33345840Scifres CM, Mead-Harvey C, Nadeau H, Reid S, Pierce S, Feghali M, Myers D, Fields D, Stoner JA. Intensive glycemic control in gestational diabetes mellitus: a randomized controlled clinical feasibility trial. Am J Obstet Gynecol MFM. 2019 Nov;1(4):100050. doi: 10.1016/j.ajogmf.2019.100050. Epub 2019 Sep 27.
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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.
Stephanie Pierce, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower glycemic targets in people with Gestational Diabetes, run by University of Oklahoma 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 6 inclusion and 10 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 6 Mar 2020. 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?
Change in baseline maternal glycemia at 32-36 weeks gestation (time frame: 5 days at 2 separate times (1st study visit at 12-32 weeks, 2nd study visit at 32-36 weeks)). 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 NCT02530866, 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 6 Mar 2020; AzTrials last refreshed its copy on 2 Nov 2026.