Glycemic Profile in Women With Gestational Diabetes Treated With Glyburide

Study Overview
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Brief Summary
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Diabetes is more likely to occur during pregnancy. When present only in pregnancy it is called gestational diabetes, and it places both mom and baby at risk for complications. Glyburide is one of the currently used treatments for diabetes during pregnancy. This drug is a medication taken by mouth that decreases sugar levels in the blood. It is known to decrease the risk of complications linked to diabetes in pregnancy. Recent studies in pregnancy have described a difference in the way and how well the drug works compared to when used outside of pregnancy. Oral blood sugar lowering agents are approved by the Food and Drug Administration (FDA) to lower blood sugar in non-pregnant subjects with diabetes. No oral (taken by mouth) blood-sugar lowering agents are FDA approved for use in pregnancy. Although Glyburide is not FDA approved for this use, it is the most commonly used oral blood sugar lowering agent in pregnancy. This research study will help us learn more about the variations in blood sugar levels in women with diabetes in pregnancy who are taking glyburide and how changes in the timing of when the glyburide is taken would affect blood glucose levels. The goals of this study are: To find the how glucose changes throughout the day in women with diabetes in pregnancy receiving glyburide To learn the effect of changing the time of taking glyburide on glucose levels To learn the effect of changing the time between glyburide doses on glucose levels To see if insulin is secreted the same throughout the day in response to a morning dose of glyburide.

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Drug: Glyburide
* Device: Continuous glucose monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women with gestational diabetes Singleton gestation Receiving glyburide for the treatment gestational diabetes Able to give consent Exclusion Criteria: Women who require insulin for the treatment of gestational diabetes Diagnosis of pregestational diabetes Poor glycemic control, > 50% of blood glucose values over 200mg/dl prior to start of the study Women receiving medications that affect glycemic control e.g. steroids, within a week of enrollment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glyburide once daily<br>Timing of glyburide dosing will be changed, glucose will be monitored using continuous a glucose monitor. | Drug: Glyburide<br> <br> Device: Continuous glucose monitor<br> <br> |
| Experimental: Glyburide twice daily<br>Dose interval and timing of glyburide dose will be changed, glucose will be monitored using continuous a glucose monitor. | Drug: Glyburide<br> <br> Device: Continuous glucose monitor<br> <br> |
| Experimental: Mixed meal tolerance test.<br>Subjects will be admitted to the Clinical Translational Research Center, receive a Mixed meal tolerance test and have timed blood draws to assess the effect of glyburide on glucose and insulin metabolism. | Drug: Glyburide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose levels throughout the day |  | One week |