Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glucose Monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes focused on measuring glucose monitoring
Eligibility 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)
Sites / Locations
- Mount Sinai Perinatal Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group - glucose check every day
Experimental group - glucose check every other day
Arm Description
Patients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.
Patients will be instructed to check their glucose every other day, 4 times glucose monitoring
Outcomes
Primary Outcome Measures
Birth weight
Fetal weight at time of delivery (grams).
Secondary Outcome Measures
APGAR score
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
Cord blood pH level
Number of NICU admission
Full Information
NCT ID
NCT04857073
First Posted
April 20, 2021
Last Updated
May 2, 2022
Sponsor
Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT04857073
Brief Title
Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
Official Title
Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
April 6, 2022 (Actual)
Study Completion Date
April 6, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
glucose monitoring
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized into one of two arms
daily, 4 times a day glucose monitoring (fasting, 2 hours post prandial x 3)
every other day, 4 times daily glucose monitoring (fasting, 2 hours post prandial x 3)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group - glucose check every day
Arm Type
Active Comparator
Arm Description
Patients will be instructed to check their glucose 4 times a day, every day. This is currently the standard of care.
Arm Title
Experimental group - glucose check every other day
Arm Type
Experimental
Arm Description
Patients will be instructed to check their glucose every other day, 4 times glucose monitoring
Intervention Type
Other
Intervention Name(s)
Glucose Monitoring
Other Intervention Name(s)
Fingerstick
Intervention Description
Glucose monitoring consists of finger stick fasting and 2 hours post prandial
Primary Outcome Measure Information:
Title
Birth weight
Description
Fetal weight at time of delivery (grams).
Time Frame
Day 1 - day of delivery
Secondary Outcome Measure Information:
Title
APGAR score
Description
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
Time Frame
Day 1 - day of delivery
Title
Cord blood pH level
Time Frame
Day 1 - day of delivery
Title
Number of NICU admission
Time Frame
Day 1 - day of delivery
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristina M Feldman, DO
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Perinatal Associates
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29370047
Citation
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
Results Reference
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Daily Versus Every Other Day Glucose Monitoring in Gestational Diabetes Mellitus
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