Gestational Diabetes, Controlled by DietNCT06744621
Glucose Frequent of A1GDM in Labor
An observational study of Gestational Diabetes, Controlled by Diet, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Gestational Diabetes, Controlled by Diet
- What is being tested?
- Fingerstick
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 30 May 2025
- 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 51 years
- Women only
- No healthy volunteers
- Adult
Study population: Patient with A1GDM (diet controlled gestational diabetes)
Who may be able to join
- All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM
- Patient with singleton gestation presenting in labor or for induction
- Patients who had "good" glucose control and were A1GDM. Good Control;
- - Patient with overall outpatient glucose average of less than 100
- - No evidence of fetopathy, large for gestational age or polyhydramnios.
- - Hgb A1c <5.7
Who cannot join
- If patient's admission accu check is >120
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Monitoring for A1GDM
This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.
- Conditions
- Gestational Diabetes, Controlled by Diet
- Being tested
- Fingerstick
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FingerstickOther
fingersticks during their labor process
| Study group | Role | What they receive |
|---|---|---|
| Infrequent | Patients will undergo one fingerstick on admission for their labor process. Receives: Other: Fingerstick | |
| Frequent | Patients will undergo fingersticks every 4 hours in latent labor and 2 hour in active labor during their labor process. Receives: Other: Fingerstick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal glucose level
Measured: at 24 hours
Secondary outcomes (4)
Number of neonates requiring insulin
Measured: at 24 hours
Number of NICU admissions
Measured: at 24 hours
Number of glucose treatments
Measured: at 24 hours
Number of neonatal with hyperbilirubinemia
Measured: at 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start5 Dec 2024
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes, Controlled by DietStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Owens, Icahn School of Medicine at Mount Sinai
- Investigators
- Thomas Owens, MD, Principal investigator, Mount Sinai West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06744621
- Sponsor's protocol ID
- STUDY-24-01116
- Status last verified
- Jul 2025
- First submitted
- 17 Dec 2024
- Last updated
- 15 Jul 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 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Monitoring for A1GDM
- ClinicalTrials.gov ID
- NCT06744621
- Acronym / sponsor ID
- STUDY-24-01116
- Conditions
- Gestational Diabetes, Controlled by Diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 20 Dec 2024 (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.
This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infrequent | – | Other: FingerstickPatients will undergo one fingerstick on admission for their labor process. |
| Frequent | – | Other: FingerstickPatients will undergo fingersticks every 4 hours in latent labor and 2 hour in active labor during their labor process. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient with A1GDM (diet controlled gestational diabetes)
Key inclusion criteria (6 listed)
- All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM
- Patient with singleton gestation presenting in labor or for induction
- Patients who had "good" glucose control and were A1GDM. Good Control;
Key exclusion criteria (1 listed)
- If patient's admission accu check is >120
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 |
|---|---|---|
| Fingerstickfingersticks during their labor process | Other | Frequent, Infrequent |
Primary outcome
Neonatal glucose level
Time frame: at 24 hours
4 secondary outcomes
Number of neonates requiring insulin
Time frame: at 24 hours
Number of NICU admissions
Time frame: at 24 hours
Number of glucose treatments
Time frame: at 24 hours
Number of neonatal with hyperbilirubinemia
Time frame: at 24 hours
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 15 Jul 2025.
- Individual participant dataSharing planned: No
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.
Thomas Owens, MD principal investigator
Mount Sinai West
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 Gestational Diabetes, Controlled by Diet, run by Icahn School of Medicine at Mount Sinai 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 1 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 15 Jul 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?
Neonatal glucose level (time frame: at 24 hours). 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 15 Jul 2025.