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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1-hour post-prandial blood glucose monitoring Arm | Other | Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating. |
|
| 2-hour post-prandial blood glucose monitoring Arm | Other | Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1 hour Blood glucose monitoring | Other | Consented patients who are diagnosed with gestational diabetes will be randomized to 1-hour postprandial blood glucose monitoring. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of adherence | 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. | During the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of postprandial glucose log complete, averaged over the duration of the study period | During the intervention | |
| Percentage of postprandial glucose log complete for each meal (breakfast, lunch, and dinner), averaged over the duration of the study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Chasen, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York Prebyterian Hospital Weill Cornell | New York | New York | 10021 | United States |
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| 2 hour blood glucose monitoring | Other | Consented patients who are diagnosed with gestational diabetes will be randomized to 2 hour post prandial blood glucose monitoring |
|
| 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 |
| Number of subjects with shoulder dystocia | At time of delivery |
| 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 |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D001786 | Blood Glucose |
| ID | Term |
|---|---|
| D005947 | Glucose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
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