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

May 29, 2024 updated by: Amy Miyoshi Valent, Oregon Health and Science University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • OHSU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.
Diagnostic test: Continuous glucose monitoring (CGM)
Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period
Other: Referent Arm
Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.
Diagnostic test: Self-Capillary Blood Glucose Monitoring (SCBG)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average time-in-range over a 24 hour period
Time Frame: From enrollment to10 days after discharge from hospital following delivery
From enrollment to10 days after discharge from hospital following delivery

Secondary Outcome Measures

Outcome Measure
Time Frame
Average time-in-range during waking hours
Time Frame: From enrollment to10 days after discharge from hospital following delivery
From enrollment to10 days after discharge from hospital following delivery
Average time-in-range while asleep
Time Frame: From enrollment to10 days after discharge from hospital following delivery
From enrollment to10 days after discharge from hospital following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Amy Valent, Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2021

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00021775

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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