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

Gestational Diabetes Clinical Trial

— iGlucose  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04206748
• Other study ID #: HSC-MS-19-0402
• Status: Recruiting
• Phase: N/A
• Start date: November 12, 2019
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2021
• Source: The University of Texas Health Science Center, Houston
• Contact: Joycelyn Corthwaite, RD
• Phone: 832-325-7205
• Email: joycelyn.a.cornthwaite[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 1, 2022
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Pregnancy in Diabetic
• Pregnancy in Diabetics
• Type2 Diabetes

Intervention

Device:
• iGlucose Smart Meter System
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
• Routine Care-RX meter
Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Smart Meter Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal morbidity		at the time of discharge (about 2-7 days after birth)
Primary	Neonatal gestational age at delivery		at delivery
Primary	# of neonates who where Small for gestational age (SGA)		at delivery
Primary	Neonatal intensive care unit (NICU) length of stay		delivery to discharge (2-7 days)
Primary	# of Neonates with hyperbilirubinemia-requiring therapy.		delivery to discharge (2-7 days)
Secondary	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)
Secondary	Maternal Mean fasting glucose		perinatal to postpartum (32 weeks)
Secondary	Maternal Mean post prandial glucose		perinatal to postpartum (32 weeks)
Secondary	Maternal # of Hypoglycemia events (<60 mg/dl)		perinatal to postpartum (32 weeks)
Secondary	Maternal weight gain during pregnancy		perinatal to postpartum (32 weeks)
Secondary	Maternal Gestational hypertension		perinatal to postpartum (32 weeks)
Secondary	Maternal Preeclampsia		perinatal to postpartum (32 weeks)
Secondary	Maternal Cesarean delivery		at delivery
Secondary	Maternal Operative vaginal delivery		at delivery
Secondary	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)