Health TrialsbyHealthPanel

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

ConditionsGestational DiabetesType2 DiabetesPregnancy in Diabetic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this 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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Patients with Type 1 diabetes

Patients with fetal major congenital abnormalities

Patients identified/referred after 30.6 weeks

Trial design

Design model

Parallel

Treatments tested in this trial

  • iGlucose Smart Meter System

    Device

    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

    Device

    Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: iGlucose Smart MeterExperimental treatment 1 intervention
Group B: Rx glucose meterPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neonatal morbidity

Time frame
at the time of discharge (about 2-7 days after birth)
2

Neonatal gestational age at delivery

Time frame
at delivery
3

# of neonates who where Small for gestational age (SGA)

Time frame
at delivery
4

Neonatal intensive care unit (NICU) length of stay

Time frame
delivery to discharge (2-7 days)

Secondary outcomes

1

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

Time frame
at the time of discharge (about 2-7 days after birth)
2

Maternal Mean fasting glucose

Time frame
perinatal to postpartum (32 weeks)
3

Maternal Mean post prandial glucose

Time frame
perinatal to postpartum (32 weeks)
4

Maternal # of Hypoglycemia events (<60 mg/dl)

Time frame
perinatal to postpartum (32 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

Smart Meter Corporation

Collaborator

Source ClinicalTrials.gov
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