iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes
iGlucose
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 12, 2019
CompletedFirst Submitted
Initial submission to the registry
November 15, 2019
CompletedFirst Posted
Study publicly available on registry
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedSeptember 2, 2021
September 1, 2021
2 years
November 15, 2019
September 1, 2021
Conditions
Outcome Measures
Primary Outcomes (5)
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 Outcomes (10)
Average Neonatal Weight
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)
- +5 more secondary outcomes
Study Arms (2)
iGlucose Smart Meter
EXPERIMENTALRx glucose meter
PLACEBO COMPARATORInterventions
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
Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with Type 1 diabetes
- Patients with fetal major congenital abnormalities
- Patients identified/referred after 30.6 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
November 15, 2019
First Posted
December 20, 2019
Study Start
November 12, 2019
Primary Completion
November 12, 2021
Study Completion
November 1, 2022
Last Updated
September 2, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share