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

Not Applicable

Recruiting

• Conditions: Type2 Diabetes; Gestational Diabetes; Pregnancy in Diabetic
• Interventions: Device: Routine Care-RX meter; Device: iGlucose Smart Meter System

• Registration Number: NCT04206748
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-02
• Primary Completion: 2021-11-12
• Study Completion: 2022-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rx glucose meter	Routine Care-RX meter	-
iGlucose Smart Meter	iGlucose Smart Meter System	-

Primary Outcome Measures

Name	Time	Method
Neonatal morbidity	at the time of discharge (about 2-7 days after birth)
Neonatal intensive care unit (NICU) length of stay	delivery to discharge (2-7 days)
# of neonates who where Small for gestational age (SGA)	at delivery
Neonatal gestational age at delivery	at delivery
# of Neonates with hyperbilirubinemia-requiring therapy.	delivery to discharge (2-7 days)

Secondary Outcome Measures

Name	Time	Method
Maternal Mean post prandial glucose	perinatal to postpartum (32 weeks)
Average Neonatal Weight	at the time of discharge (about 2-7 days after birth)	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
Maternal # of Hypoglycemia events (<60 mg/dl)	perinatal to postpartum (32 weeks)
Maternal weight gain during pregnancy	perinatal to postpartum (32 weeks)
Maternal Preeclampsia	perinatal to postpartum (32 weeks)
Maternal Mean fasting glucose	perinatal to postpartum (32 weeks)
Maternal Cesarean delivery	at delivery
Effect of SMBG checks on pregnancy	perinatal to postpartum (32 weeks)	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.
Maternal Gestational hypertension	perinatal to postpartum (32 weeks)
Maternal Operative vaginal delivery	at delivery

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States