iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes

Study Overview
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Brief Summary
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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

Official Title
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iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial

Conditions
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Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic

Intervention / Treatment
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* Device: iGlucose Smart Meter System
* Device: Routine Care-RX meter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All patients >/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks. Non-anomalous singletons Ability to provide informed consent Exclusion Criteria Patients with Type 1 diabetes Patients with fetal major congenital abnormalities Patients identified/referred after 30.6 weeks

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iGlucose Smart Meter<br> | Device: iGlucose Smart Meter System<br>* 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<br>|
| Placebo Comparator: Rx glucose meter<br> | Device: Routine Care-RX meter<br>* Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |