Gestational DiabetesNCT05062460
Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics
A study testing 1 hour Blood glucose monitoring and 2 hour blood glucose monitoring in people with Gestational Diabetes, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- 1 hour Blood glucose monitoring and 2 hour blood glucose monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2021to 1 May 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant patients with singleton gestation who are ≥ 18 years of age.
- Diagnosis of GDM after 24 0/7 weeks.
- For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.
Who cannot join
- Type 1 pre-gestational diabetes
- Type 2 pre-gestational diabetes
- GDM diagnosed prior to 24 0/7 weeks gestation.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York Prebyterian Hospital Weill Cornell
New York, New York, 10021
About this study
Official title: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial
The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.
The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
Read the detailed description
Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.
- Conditions
- Gestational Diabetes
- Being tested
- 1 hour Blood glucose monitoring, 2 hour blood glucose monitoring
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 hour Blood glucose monitoringOther
Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
2 hour blood glucose monitoringOther
Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| 1-hour post-prandial blood glucose monitoring Arm | Other | Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating. Receives: Other: 1 hour Blood glucose monitoring |
| 2-hour post-prandial blood glucose monitoring Arm | Other | Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating. Receives: Other: 2 hour blood glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adherence
Evaluate rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
Measured: During the intervention
Secondary outcomes (22)
Percentage of postprandial glucose log complete, averaged over the duration of the study period
Measured: During the intervention
Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period
Measured: During the intervention
Percentage of elevated blood glucose values per week, averaged over the duration of the study period
Measured: During the intervention
Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.
Measured: During the intervention
Gestational age at medication therapy initiation
Measured: During the intervention
Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy
Measured: During the intervention
Number of subjects with a vaginal delivery
Measured: At time of delivery
Number of subjects with an operative delivery
Measured: At time of delivery
Number of subjects with a caesarean section delivery
Measured: At time of delivery
Number of subjects with a preeclampsia diagnosis
Measured: During intervention
Neonatal birthweight
Measured: At time of delivery
Number of subjects with shoulder dystocia
Measured: At time of delivery
Number of patients with 3rd or 4th degree perineal lacerations
Measured: At time of delivery
Number of patients with postpartum hemorrhage.
Measured: At time of delivery
Number of stillbirths
Measured: At time of delivery
Number of NICU admissions
Measured: At time of delivery
Number of patients requiring supplemental oxygen support
Measured: At time of delivery
Number of patients with diagnosis of hypoglycemia
Measured: At time of delivery
Number of patients with diagnosis of hyperbilirubinemia
Measured: At time of delivery
Number of patients with clavicular fracture
Measured: At time of delivery
Number of patients with humeral fracture
Measured: At time of delivery
Number of patients with brachial plexus palsy
Measured: At time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start15 Jul 2021
- Primary completion1 Jun 2024
- Study completion1 May 2025
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 Weill Medical College of Cornell 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Chasen, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062460
- Sponsor's protocol ID
- 20-10022829
- Status last verified
- May 2025
- First submitted
- 19 Aug 2021
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05062460
- Acronym / sponsor ID
- 20-10022829
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 30 Sep 2021 (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 purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating.
The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
Detailed description
Consented patients who are diagnosed with gestational diabetes will be randomized to either 1-hour or 2-hour postprandial blood glucose monitoring. A retrospective chart review from July 2020 until study commencement for patients from the same clinic will be used as a historical control group. This study will assess differences in adherence to testing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-hour post-prandial blood glucose monitoring Arm | Other | Other: 1 hour Blood glucose monitoringArm in which participants are randomized to blood glucose monitoring at 1 hour after eating. |
| 2-hour post-prandial blood glucose monitoring Arm | Other | Other: 2 hour blood glucose monitoringArm in which participants are randomized to blood glucose monitoring at 2 hours after eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant patients with singleton gestation who are ≥ 18 years of age.
- Diagnosis of GDM after 24 0/7 weeks.
- For diagnosing GDM, a two-step screening algorithm will be performed according to the American College of Obstetrics and Gynecologists.4 Specifically, a 1-hour 50-g glucose-loading test is given first. Plasma glucose levels between 140 and 200 mg/dL will be considered elevated. Confirmatory testing will then be performed using a 3-hour 100-g glucose tolerance test. Diagnosis was made when two of the four values were elevated. Abnormal glucose value thresholds are established via the criteria suggested by Carpenter and Coustan: fasting value ≥ 95 mg/dL, 1-hour ≥ 180 mg/dL, 2-hour ≥ 155 mg/dL, and 3-hour ≥ 140 mg/dL.9 Patients with a blood glucose level greater than 200 mg/dL after 1-hour 50-g glucose-loading test will be diagnosed with GDM without requirement for the 3-hour 100-g glucose tolerance test.
Key exclusion criteria (3 listed)
- Type 1 pre-gestational diabetes
- Type 2 pre-gestational diabetes
- GDM diagnosed prior to 24 0/7 weeks 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 |
|---|---|---|
| 1 hour Blood glucose monitoringConsented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring. | Other | 1-hour post-prandial blood glucose monitoring Arm |
| 2 hour blood glucose monitoringConsented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring | Other | 2-hour post-prandial blood glucose monitoring Arm |
Primary outcome
Rate of adherence
Time frame: During the intervention
Evaluate rate of adherence (binary outcome defined as <80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.
22 secondary outcomes
Percentage of postprandial glucose log complete, averaged over the duration of the study period
Time frame: During the intervention
Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period
Time frame: During the intervention
Percentage of elevated blood glucose values per week, averaged over the duration of the study period
Time frame: During the intervention
Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.
Time frame: During the intervention
Gestational age at medication therapy initiation
Time frame: During the intervention
Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy
Time frame: During the intervention
Number of subjects with a vaginal delivery
Time frame: At time of delivery
Number of subjects with an operative delivery
Time frame: At time of delivery
Number of subjects with a caesarean section delivery
Time frame: At time of delivery
Number of subjects with a preeclampsia diagnosis
Time frame: During intervention
Neonatal birthweight
Time frame: At time of delivery
Number of subjects with shoulder dystocia
Time frame: At time of delivery
Number of patients with 3rd or 4th degree perineal lacerations
Time frame: At time of delivery
Number of patients with postpartum hemorrhage.
Time frame: At time of delivery
Number of stillbirths
Time frame: At time of delivery
Number of NICU admissions
Time frame: At time of delivery
Number of patients requiring supplemental oxygen support
Time frame: At time of delivery
Number of patients with diagnosis of hypoglycemia
Time frame: At time of delivery
Number of patients with diagnosis of hyperbilirubinemia
Time frame: At time of delivery
Number of patients with clavicular fracture
Time frame: At time of delivery
Number of patients with humeral fracture
Time frame: At time of delivery
Number of patients with brachial plexus palsy
Time frame: At time of 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 23 May 2025.
- Individual participant dataSharing planned: No
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Role of ET-1, Physical Activity, and Sedentary Behavior in Microvascular Dysfunction Following GDM
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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.
Stephen Chasen, MD principal investigator
Weill Medical College of Cornell 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 1 hour Blood glucose monitoring and 2 hour blood glucose monitoring in people with Gestational Diabetes, run by Weill Medical College of Cornell 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 3 inclusion and 3 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 23 May 2025. 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?
Rate of adherence (time frame: During the intervention). 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 23 May 2025.