- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04605497
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
March 23, 2023 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
Recruiting
Conditions
Study Type
Interventional
Enrollment (Anticipated)
110
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 Contact
- Name: Women's Health Research Unit Department of Ob/Gyn
- Phone Number: 503-494-3666
- Email: whru@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- OHSU
-
Contact:
- Amy Valent
- Email: valent@ohsu.edu
-
-
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
Genders Eligible for Study
Female
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.
|
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.
|
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.
Collaborators
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 (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
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)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
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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