Effectiveness and Safety Study of the Dexcom G4 Platinum With Modified Algorithm
NCT ID: NCT02087995
Last Updated: 2017-08-24
Study Results
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View full resultsBasic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2013-12-31
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Continuous Glucose Monitoring System
Single-Arm, CGM Device Glucose challenge performed during a clinic session to obtain accuracy data for the CGM system compared to a venous reference measurement
Continuous Glucose Monitoring
A prescribed clinic session day for participating subjects.
Interventions
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Continuous Glucose Monitoring
A prescribed clinic session day for participating subjects.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Type 1 diabetes or Type 2 diabetes on Intensive Insulin Therapy (ITT)
* Willing to participate in a clinic session
Exclusion Criteria
* Pregnancy
* Hematocrit (HCT) \<35% (females) and 38% (males)
* Dialysis, history of cardiovascular disease, epilepsy, severe migraines in the past 6 months, adrenal disease, syncope, significant hypoglycemia unawareness, or a history of severe hypoglycemia within the last 6 months.
* Any condition that, in the opinion of the Investigator, would interfere with their participation in the study or pose and excessive risk to study staff.
18 Years
ALL
No
Sponsors
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DexCom, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Andy Balo
Role: STUDY_CHAIR
DexCom, Inc.
Locations
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John Muir Physician Network Clinical Research
Concord, California, United States
AMCR Institute
Escondido, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Countries
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References
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Peyser TA, Nakamura K, Price D, Bohnett LC, Hirsch IB, Balo A. Hypoglycemic Accuracy and Improved Low Glucose Alerts of the Latest Dexcom G4 Platinum Continuous Glucose Monitoring System. Diabetes Technol Ther. 2015 Aug;17(8):548-54. doi: 10.1089/dia.2014.0415. Epub 2015 May 11.
Other Identifiers
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PTL901100
Identifier Type: -
Identifier Source: org_study_id
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