Performance of the Dexcom Continuous Glucose Monitoring (CGM) System in Pregnant Women With Diabetes Mellitus
NCT ID: NCT04905628
Last Updated: 2022-02-21
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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UNKNOWN
100 participants
OBSERVATIONAL
2021-07-08
2022-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Dexcom CGM System
Dexcom CGM System
Dexcom CGM System
Dexcom CGM System
Interventions
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Dexcom CGM System
Dexcom CGM System
Eligibility Criteria
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Inclusion Criteria
* Confirmed pregnancy
* Diagnosis of Gestational Diabetes (GDM), Type 1 Diabetes Mellitus (T1DM), or Type 2 Diabetes Mellitus (T2DM)
* Willing to wear up to the required number of Systems for the total duration of study wear
* Able to follow study procedures;
* Able to speak, read, and write in English or Spanish.
Exclusion Criteria
* Known allergy to medical-grade adhesives
* Hematocrit outside specification
* Prescribed drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications during current pregnancy
* Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period
* Currently using Hydroxyurea for treatment
* Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period
18 Years
FEMALE
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Carol Levy, MD, CDCES
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Sarit Polsky,, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Barbara Davis Center
Florence Brown, MD
Role: PRINCIPAL_INVESTIGATOR
Joslin Diabetes Center
Kristin Castorino, DO
Role: PRINCIPAL_INVESTIGATOR
Sansum Diabetes Research Institute
Amy Valent, DO
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Sansum Diabetes Research Institute
Santa Barbara, California, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Oregon Health & Science University
Portland, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Polsky S, Valent AM, Isganaitis E, Castorino K, O'Malley G, Beck SE, Gao P, Laffel LM, Brown FM, Levy CJ. Performance of the Dexcom G7 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2024 May;26(5):307-312. doi: 10.1089/dia.2023.0516. Epub 2024 Mar 1.
Other Identifiers
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PTL-904284
Identifier Type: -
Identifier Source: org_study_id
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