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

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

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

Study Overview

• Status: Recruiting
• Conditions: Type2 Diabetes; Gestational Diabetes; Pregnancy in Diabetic
• Intervention / Treatment: Device: iGlucose Smart Meter System; Device: Routine Care-RX meter

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Joycelyn Corthwaite, RD; Phone Number: 832-325-7205; Email: joycelyn.a.cornthwaite@uth.tmc.edu
• Study Contact Backup: Name: Clara Ward, MD; Phone Number: 713-500-6412; Email: clara.ward@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Joycelyn Cornthwaite, RD; Phone Number: 832-325-7205; Email: joycelyn.a.cornthwaite@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iGlucose Smart Meter	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
PLACEBO_COMPARATOR: Rx glucose meter	Device: Routine Care-RX meter; Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Smart Meter Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2019
• Primary Completion (ANTICIPATED): November 12, 2021
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (ACTUAL): December 20, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 2, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: HSC-MS-19-0402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No