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Recruiting NCT04206748

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

No phase Interventional Gestational Diabetes Type2 Diabetes Pregnancy in Diabetic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iGlucose Smart Meter System, Routine Care-RX meter.
Who it may be relevant to
Registry conditions: Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

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

Primary outcome measures

  • Neonatal morbidity [Time frame: at the time of discharge (about 2-7 days after birth)]
  • Neonatal gestational age at delivery [Time frame: at delivery]
  • # of neonates who where Small for gestational age (SGA) [Time frame: at delivery]
  • Neonatal intensive care unit (NICU) length of stay [Time frame: delivery to discharge (2-7 days)]
  • # of Neonates with hyperbilirubinemia-requiring therapy. [Time frame: delivery to discharge (2-7 days)]
Secondary outcome measures (10)
  • Average Neonatal Weight [Time frame: at the time of discharge (about 2-7 days after birth)]
  • Maternal Mean fasting glucose [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal Mean post prandial glucose [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal # of Hypoglycemia events (<60 mg/dl) [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal weight gain during pregnancy [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal Gestational hypertension [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal Preeclampsia [Time frame: perinatal to postpartum (32 weeks)]
  • Maternal Cesarean delivery [Time frame: at delivery]
  • Maternal Operative vaginal delivery [Time frame: at delivery]
  • Effect of SMBG checks on pregnancy [Time frame: perinatal to postpartum (32 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT04206748 · HSC-MS-19-0402

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗