A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics
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|ClinicalTrials.gov Identifier: NCT02456922|
Recruitment Status : Withdrawn (For administraive reasons)
First Posted : May 29, 2015
Last Update Posted : September 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Type 2 Diabetes||Device: Harmony 1 Sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Performance Evaluation of the Harmony 1 Sensors in Adults and Pediatrics|
|Estimated Study Start Date :||July 2018|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Subjects wearing Harmony 1 Sensor for up to 10 days.
Device: Harmony 1 Sensor
Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
- Harmony 1 Sensor accuracy [ Time Frame: 10 days ]Sensor accuracy will be evaluated compared to YSI plasma glucose values during frequent sample testing. A within 30% mean agreement rate (±22.5 mg/dL when Reference BG ≤ 75 mg/dL) between sensor and YSI will be evaluated against the null Hypothesis for varying glucose ranges.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456922
|Principal Investigator:||Ronald Brazg, MD||Rainier Clinical Research Center|
|Principal Investigator:||Mark Christiansen, MD||Diablo Clinical Research|
|Principal Investigator:||Timothy Bailey, MD||AMCR Institute|
|Principal Investigator:||Satish Garg, MD||Barbara Davis Center|
|Principal Investigator:||Robert Slover, MD||Barbara Davis Center|
|Principal Investigator:||Kevin Kaiserman, MD||SoCal Diabetes|
|Principal Investigator:||Bruce Bode, MD||Atlanta Diabetes Associates|
|Principal Investigator:||Luis Casaubon, MD||Texas Diabetes & Endocrinology|