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NCT Number: NCT04206748

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

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

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Pregnancy in Diabetic Pregnancy in Diabetics Type2 Diabetes Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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)

  5. # of Neonates with hyperbilirubinemia-requiring therapy.

    Time frame: delivery to discharge (2-7 days)

Secondary outcomes

  1. Average Neonatal Weight

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

    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

  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)

  5. Maternal weight gain during pregnancy

    Time frame: perinatal to postpartum (32 weeks)

  6. Maternal Gestational hypertension

    Time frame: perinatal to postpartum (32 weeks)

  7. Maternal Preeclampsia

    Time frame: perinatal to postpartum (32 weeks)

  8. Maternal Cesarean delivery

    Time frame: at delivery

  9. Maternal Operative vaginal delivery

    Time frame: at delivery

  10. Effect of SMBG checks on pregnancy

    Time frame: perinatal to postpartum (32 weeks)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Clara Ward, MD

CONTACT

[email protected]

713-500-6412

Joycelyn Corthwaite, RD

CONTACT

[email protected]

832-325-7205

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Smart Meter Corporation

Registry information

Official study 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

Acronym: iGlucose

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Dec 20, 2019
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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