Pilot Prospective CGM Quality Improvement (QI) Project in Pregnancy
NCT ID: NCT02556554
Last Updated: 2020-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
67 participants
INTERVENTIONAL
2015-08-31
2017-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Routine Care
Standard of Care in the Pregnancy and Women's Health clinic.
No interventions assigned to this group
Dexcom G4 Platinum CGM system
An intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy.
Dexcom G4 or G5 Platinum CGM system
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Dexcom G4 Platinum CGM system with Share™
A treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™ remote monitoring capabilities during pregnancy.
Dexcom G4 or G5 Platinum CGM system with Share
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
Interventions
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Dexcom G4 or G5 Platinum CGM system
Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
Dexcom G4 or G5 Platinum CGM system with Share
Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
Eligibility Criteria
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Inclusion Criteria
* Female aged 18 years and older
* T1D duration \>1 year
* Pregnancy with confirmation of gestational age 13 weeks or less
* Willingness to routinely practice at least 3-7 blood glucose measurements per day
* Using MDI or CSII therapy
* Willingness to provide an A1C level
* Ability and willingness to adhere to the protocol including scheduled study visits for the duration of the pregnancy
* Able to speak, read, and write English
Exclusion Criteria
* Known allergy to adhesives
* Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
18 Years
FEMALE
No
Sponsors
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DexCom, Inc.
INDUSTRY
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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Sarit Polsky, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado
Aurora, Colorado, United States
Countries
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References
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Shah VN, Snell-Bergeon JK, Demmitt JK, Joshee P, Garcetti R, Pyle L, Polsky S. Relationship Between Time-in-Range, HbA1c, and the Glucose Management Indicator in Pregnancies Complicated by Type 1 Diabetes. Diabetes Technol Ther. 2021 Dec;23(12):783-790. doi: 10.1089/dia.2021.0093. Epub 2021 Nov 3.
Buschur EO, Campbell K, Pyle L, Garcetti R, Joshee P, Demmitt JK, Snell-Bergeon JK, Polsky S. Exploratory Analysis of Glycemic Control and Variability Over Gestation Among Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Nov;23(11):768-772. doi: 10.1089/dia.2021.0138.
Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous Glucose Monitor Use With Remote Monitoring Reduces Fear of Hypoglycemia in Pregnant Women With Type 1 Diabetes: A Pilot Study. J Diabetes Sci Technol. 2020 Jan;14(1):191-192. doi: 10.1177/1932296819890864. Epub 2019 Nov 28. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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15-1006
Identifier Type: -
Identifier Source: org_study_id
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