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| Name | Class |
|---|---|
| Smart Meter Corporation | INDUSTRY |
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The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iGlucose Smart Meter | Experimental |
| |
| Rx glucose meter | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iGlucose Smart Meter System | Device | Subjects will have routine care enhanced by use of theThe iGlucose Smart meter system. This is an example of integration of a SMBG system with internet-based technology; including cell phone notifications for reminders, feedback, and communication with clinicians |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal morbidity | at the time of discharge (about 2-7 days after birth) | |
| Neonatal gestational age at delivery | at delivery | |
| # of neonates who where Small for gestational age (SGA) | at delivery | |
| Neonatal intensive care unit (NICU) length of stay | delivery to discharge (2-7 days) | |
| # of Neonates with hyperbilirubinemia-requiring therapy. | delivery to discharge (2-7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Neonatal Weight | To evaluate the relationship of change in average neonatal weight to two skill sets of Self-monitoring of blood glucose (SMBG), operational and interpretive, as demonstrated by patient-perceived self-efficacy and adherence to self-care behaviors | at the time of discharge (about 2-7 days after birth) |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joycelyn Corthwaite, RD | Contact | 832-325-7205 | joycelyn.a.cornthwaite@uth.tmc.edu | |
| Clara Ward, MD | Contact | 713-500-6412 | clara.ward@uth.tmc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Routine Care-RX meter | Device | Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary. |
|
| Maternal Mean fasting glucose |
| perinatal to postpartum (32 weeks) |
| Maternal Mean post prandial glucose | perinatal to postpartum (32 weeks) |
| Maternal # of Hypoglycemia events (<60 mg/dl) | perinatal to postpartum (32 weeks) |
| Maternal weight gain during pregnancy | perinatal to postpartum (32 weeks) |
| Maternal Gestational hypertension | perinatal to postpartum (32 weeks) |
| Maternal Preeclampsia | perinatal to postpartum (32 weeks) |
| Maternal Cesarean delivery | at delivery |
| Maternal Operative vaginal delivery | at delivery |
| Effect of SMBG checks on pregnancy | To evaluate relationship between percent of total achieved SMBG checks, diabetes distress, and maternal and neonatal outcomes, for women living with GDM and T2DM during pregnancy. | perinatal to postpartum (32 weeks) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 9, 2023 | Jun 5, 2023 | 2 |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D011254 | Pregnancy in Diabetics |
| 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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