Skip to main content
OpenTrials
Completed

NCT Number: NCT04605497

Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

Completed

Looking for future studies?

Notify Me

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 Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OHSU

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-55 years
  • Singleton pregnancy ≥20 weeks gestation
  • Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan)
  • Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver

Exclusion criteria

  • Chronic immunosuppression
  • Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder
  • Known allergy to medical grade adhesives
  • Pre-gestational diabetes
  • Multifetal gestation
  • Current alcohol or illicit drug use
  • Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Treatment and study plan

Continuous glucose monitoring (CGM)

Diagnostic Test

Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period

Self-Capillary Blood Glucose Monitoring (SCBG)

Diagnostic Test

Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear

Primary outcomes

  1. Average time-in-range over a 24 hour period

    Time frame: From enrollment to10 days after discharge from hospital following delivery

Secondary outcomes

  1. Average time-in-range during waking hours

    Time frame: From enrollment to10 days after discharge from hospital following delivery

  2. Average time-in-range while asleep

    Time frame: From enrollment to10 days after discharge from hospital following delivery

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 28, 2020
Registry last updated
May 31, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.