Gestational Diabetes
Conditions
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.
Interventions
OTHER1 hour Blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring.
OTHER2 hour blood glucose monitoring
Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adherence | During the intervention | Evaluate 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. |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period | During the intervention |
| Percentage of elevated blood glucose values per week, averaged over the duration of the study period | During the intervention |
| Number of patients who start insulin or oral hyperglycemic medication therapy prior to delivery. | During the intervention |
| Gestational age at medication therapy initiation | During the intervention |
| Timeframe from diagnosis of gestational diabetes to initiation of insulin therapy | During the intervention |
| Number of subjects with a vaginal delivery | At time of delivery |
| Number of subjects with an operative delivery | At time of delivery |
| Number of subjects with a caesarean section delivery | At time of delivery |
| Number of subjects with a preeclampsia diagnosis | During intervention |
| Neonatal birthweight | At time of delivery |
| Percentage of postprandial glucose log complete, averaged over the duration of the study period | During the intervention |
| Number of patients with 3rd or 4th degree perineal lacerations | At time of delivery |
| Number of patients with postpartum hemorrhage. | At time of delivery |
| Number of stillbirths | At time of delivery |
| Number of NICU admissions | At time of delivery |
| Number of patients requiring supplemental oxygen support | At time of delivery |
| Number of patients with diagnosis of hypoglycemia | At time of delivery |
| Number of patients with diagnosis of hyperbilirubinemia | At time of delivery |
| Number of patients with clavicular fracture | At time of delivery |
| Number of patients with humeral fracture | At time of delivery |
| Number of patients with brachial plexus palsy | At time of delivery |
| Number of subjects with shoulder dystocia | At time of delivery |
Countries
United States
Outcome results
None listed