Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857073
Recruitment Status : Recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
Kristina Feldman, Icahn School of Medicine at Mount Sinai

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Other: Glucose Monitoring Not Applicable

Detailed Description:
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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)
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
Actual Study Start Date : April 8, 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: 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.
Other: Glucose Monitoring
Glucose monitoring consists of finger stick fasting and 2 hours post prandial
Other Name: Fingerstick

Experimental: Experimental group - glucose check every other day
Patients will be instructed to check their glucose every other day, 4 times glucose monitoring
Other: Glucose Monitoring
Glucose monitoring consists of finger stick fasting and 2 hours post prandial
Other Name: Fingerstick




Primary Outcome Measures :
  1. Birth weight [ Time Frame: Day 1 - day of delivery ]
    Fetal weight at time of delivery (grams).


Secondary Outcome Measures :
  1. APGAR score [ Time Frame: Day 1 - day of delivery ]
    APGAR measures the baby's color, heart rate, reflexes, muscle tone, and respiratory effort and total score from 1 to 10, with higher score indicating better health outcomes

  2. Cord blood pH level [ Time Frame: Day 1 - day of delivery ]
  3. Number of NICU admission [ Time Frame: Day 1 - day of delivery ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857073


Contacts
Layout table for location contacts
Contact: Kristina M Feldman, DO 914-319-4015 kristina.feldman@mountsinai.org

Locations
Layout table for location information
United States, New York
Mount Sinai Perinatal Associates Recruiting
New York, New York, United States, 10019
Contact: Sophia Scarpelli Shchur, RN    212-523-7579      
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
Layout table for investigator information
Principal Investigator: Kristina M Feldman, DO Icahn School of Medicine at Mount Sinai
Publications:
Layout table for additonal information
Responsible Party: Kristina Feldman, Maternal Fetal Medicine Fellow, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04857073    
Other Study ID Numbers: IRB 20-01914
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kristina Feldman, Icahn School of Medicine at Mount Sinai:
glucose monitoring
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications