Back to resultsiGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes (iGlucose)
Primary Purpose
Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
iGlucose Smart Meter System
Routine Care-RX meter
Sponsored by
About this trial
This is an interventional diagnostic trial for Gestational Diabetes
Eligibility Criteria
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
Sites / Locations
- The University of Texas Health Science Center at HoustonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
iGlucose Smart Meter
Rx glucose meter
Arm Description
Outcomes
Primary Outcome Measures
Neonatal morbidity
Neonatal gestational age at delivery
# of neonates who where Small for gestational age (SGA)
Neonatal intensive care unit (NICU) length of stay
# of Neonates with hyperbilirubinemia-requiring therapy.
Secondary Outcome Measures
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
Maternal Mean fasting glucose
Maternal Mean post prandial glucose
Maternal # of Hypoglycemia events (<60 mg/dl)
Maternal weight gain during pregnancy
Maternal Gestational hypertension
Maternal Preeclampsia
Maternal Cesarean delivery
Maternal Operative vaginal 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.
Full Information
NCT ID
NCT04206748
First Posted
November 15, 2019
Last Updated
September 1, 2021
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Smart Meter Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04206748
Brief Title
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 12, 2019 (Actual)
Primary Completion Date
November 12, 2021 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
Smart Meter Corporation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
iGlucose Smart Meter
Arm Type
Experimental
Arm Title
Rx glucose meter
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
iGlucose Smart Meter System
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Routine Care-RX meter
Intervention Description
Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.
Primary Outcome Measure Information:
Title
Neonatal morbidity
Time Frame
at the time of discharge (about 2-7 days after birth)
Title
Neonatal gestational age at delivery
Time Frame
at delivery
Title
# of neonates who where Small for gestational age (SGA)
Time Frame
at delivery
Title
Neonatal intensive care unit (NICU) length of stay
Time Frame
delivery to discharge (2-7 days)
Title
# of Neonates with hyperbilirubinemia-requiring therapy.
Time Frame
delivery to discharge (2-7 days)
Secondary Outcome Measure Information:
Title
Average Neonatal Weight
Description
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
Time Frame
at the time of discharge (about 2-7 days after birth)
Title
Maternal Mean fasting glucose
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal Mean post prandial glucose
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal # of Hypoglycemia events (<60 mg/dl)
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal weight gain during pregnancy
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal Gestational hypertension
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal Preeclampsia
Time Frame
perinatal to postpartum (32 weeks)
Title
Maternal Cesarean delivery
Time Frame
at delivery
Title
Maternal Operative vaginal delivery
Time Frame
at delivery
Title
Effect of SMBG checks on pregnancy
Description
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.
Time Frame
perinatal to postpartum (32 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joycelyn Corthwaite, RD
Phone
832-325-7205
Email
joycelyn.a.cornthwaite@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Clara Ward, MD
Phone
713-500-6412
Email
clara.ward@uth.tmc.edu
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joycelyn Cornthwaite, RD
Phone
832-325-7205
Email
joycelyn.a.cornthwaite@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Sunbola Ashimi, PhD
Phone
713-500-6410
Email
sunbola.s.ashimi@uth.tmc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes
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