Clinical trial NCT05062460: Glucose Testing in GDM: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics
Official title: Adherence to One- Versus Two-hour Postprandial Glucose Monitoring in Gestational Diabetics: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Type 1 pre-gestational diabetes
* Type 2 pre-gestational diabetes
* GDM diagnosed prior to 24 0/7 weeks gestation.

Primary outcomes:
measure: Rate of adherence
timeFrame: During the intervention
Secondary outcomes:
measure: Percentage of postprandial glucose log complete, averaged over the duration of the study period
timeFrame: During the intervention
measure: Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period
timeFrame: During the intervention
measure: Percentage of elevated blood glucose values per week, averaged over the duration of the study period
timeFrame: During the intervention
measure: Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery.
timeFrame: During the intervention
measure: Gestational age at medication therapy initiation
timeFrame: During the intervention
measure: Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy
timeFrame: During the intervention
measure: Number of subjects with a vaginal delivery
timeFrame: At time of delivery
measure: Number of subjects with an operative delivery
timeFrame: At time of delivery
measure: Number of subjects with a caesarean section delivery
timeFrame: At time of delivery
measure: Number of subjects with a preeclampsia diagnosis
timeFrame: During intervention
measure: Neonatal birthweight
timeFrame: At time of delivery
measure: Number of subjects with shoulder dystocia
timeFrame: At time of delivery
measure: Number of patients with 3rd or 4th degree perineal lacerations
timeFrame: At time of delivery
measure: Number of patients with postpartum hemorrhage.
timeFrame: At time of delivery
measure: Number of stillbirths
timeFrame: At time of delivery
measure: Number of NICU admissions
timeFrame: At time of delivery
measure: Number of patients requiring supplemental oxygen support
timeFrame: At time of delivery
measure: Number of patients with diagnosis of hypoglycemia
timeFrame: At time of delivery
measure: Number of patients with diagnosis of hyperbilirubinemia
timeFrame: At time of delivery
measure: Number of patients with clavicular fracture
timeFrame: At time of delivery
measure: Number of patients with humeral fracture
timeFrame: At time of delivery
measure: Number of patients with brachial plexus palsy
timeFrame: At time of delivery
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Prebyterian Hospital Weill Cornell
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Stephen Chasen, MD
role: PRINCIPAL_INVESTIGATOR
References: