Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-10

Study Completion Date

2022-04-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Gestational diabetes mellitus (GDM) occurs secondary to carbohydrate intolerance in pregnancy. Screening of GDM occurs between 24 to 28 weeks gestation by a screening 1-hour 50g glucose challenge test and confirmed with a 100g 3-hour fasting glucose tolerance test. Once patients are diagnosed with GDM, they are instructed to check their fingerstick blood glucose four times daily, every day. There is insufficient evidence to determine the ideal frequency and timing of glucose monitoring in patients diagnosed with GDM and no absolute guidelines put in place by the American College of Obstetricians and Gynecologists (ACOG). The study team aims to confirm non inferiority on the patient population on the effects of daily (4x daily) versus every other day (4x daily) glucose monitoring in all patients diagnosed with GDM.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes

NCT01818557

Gestational Diabetes

COMPLETED NA

Early Versus Late Monitoring Among Pregnant Women With a History of Gestational Diabetes

NCT06545227

Pregnancy Complications Gestational Diabetes

RECRUITING

Pregnancy and Postpartum CGM in GDM

NCT07174245

Gestational Diabetes

RECRUITING

Frequency of Glucose Monitoring in Labor

NCT06373432

Neonatal Hypoglycemia

COMPLETED NA

Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

NCT05430204

Gestational Diabetes

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Gestational diabetes mellitus (GDM) occurs secondary to carbohydrate intolerance in pregnancy. Screening of GDM occurs between 24 to 28 weeks gestation by a screening 1-hour 50g glucose challenge test and confirmed with a 100g 3-hour fasting glucose tolerance test. In the study team's practice, once a patient is diagnosed with GDM, they are enrolled in the Diabetes in Pregnancy program, undergo nutritional education, diabetes education and have their care overseen by a Maternal-Fetal Medicine specialist. They are instructed to check their fingerstick blood glucose four times daily, every day. There is insufficient evidence to determine the ideal frequency and timing of glucose monitoring in patients diagnosed with GDM and no absolute guidelines put in place by the American College of Obstetricians and Gynecologists. In 2017, a randomized control trial was performed by Menedez-Figeroa et al, showing non inferiority in patients diagnosed with GDM who were instructed to perform every other day (4 time daily) glucose monitoring versus daily (4 times daily) glucose monitoring with their primary outcome being a 5% change in birthweight between groups at delivery. The study team aims to confirm non inferiority on the patient population on the effects of daily (4x daily) versus every other day (4x daily) glucose monitoring in all patients diagnosed with GDM with the primary outcome being a 0% difference in birth weight. The study team will be enrolling approximately 300 patients. If a patient is enrolled in the study, there will be no excursion from normally scheduled visits (including follow ups), medications regimens, or procedure (including ultrasounds). They will remain in the Diabetes in Pregnancy program throughout their pregnancy. Participants will be enrolled at the first visit with the high risk doctor, and they will be asked to perform standard (4x daily) fingerstick monitoring, or every other day fingerstick monitoring (4x daily, every other day). Data collected from the patient (including labs, and fingerstick glucose values) will not be exclusively for research purposes, and will be collected as a routine part of the patients care

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gestational Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into one of two arms

1. daily, 4 times a day glucose monitoring (fasting, 2 hours post prandial x 3)
2. every other day, 4 times daily glucose monitoring (fasting, 2 hours post prandial x 3)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group - glucose check every day

Patients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.

Group Type ACTIVE_COMPARATOR

Glucose Monitoring

Intervention Type OTHER

Glucose monitoring consists of finger stick fasting and 2 hours post prandial

Experimental group - glucose check every other day

Patients will be instructed to check their glucose every other day, 4 times glucose monitoring

Group Type EXPERIMENTAL

Glucose Monitoring

Intervention Type OTHER

Glucose monitoring consists of finger stick fasting and 2 hours post prandial

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Glucose Monitoring

Glucose monitoring consists of finger stick fasting and 2 hours post prandial

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fingerstick

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Singleton pregnancies in women 18 years or older
* Diagnosis of GDM between 24 to 28 weeks gestation

Exclusion Criteria

* Preexisting diabetes mellitus or GDM diagnosed prior to 24 weeks by early GDM screening (including patients currently on insulin or any oral hypoglycemic agent)
* Diagnosis of GDM based on fingerstick paneling
* Women who are on chronic steroid therapy
* Multifetal gestation
* Patients with GTT fasting value \>100 (which would indicate a diagnosis of pre-diabetes according to the American Diabetes Association)
* Patients who exhibited poor compliance after the first two weeks of glucose monitoring (which is defined as less than 20% of expected values recorded during the 2 week period of initial testing)

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes