Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
NCT ID: NCT04605497
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
111 participants
INTERVENTIONAL
2021-02-11
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Arm
Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.
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
Referent Arm
Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.
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
Interventions
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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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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DexCom, Inc.
INDUSTRY
Oregon Health and Science University
OTHER
Responsible Party
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Amy Miyoshi Valent
Assistant Professor
Principal Investigators
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Amy Valent
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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OHSU
Portland, Oregon, United States
Countries
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Other Identifiers
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STUDY00021775
Identifier Type: -
Identifier Source: org_study_id
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