Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04020822|
Recruitment Status : Completed
First Posted : July 16, 2019
Results First Posted : September 16, 2020
Last Update Posted : September 16, 2020
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Type 2 Diabetes||Device: Guardian Sensor (3)||Not Applicable|
The study is a multi-center, prospective single-arm design without controls. All subjects will be assigned to treatment for 11 days of sensor wear. Each subject will wear 4 Guardian Sensor (3)s, and each will be connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter. Subjects will not use sensor glucose values for diabetes management.
On days 1, 3, 5, and 6, subjects will be asked to measure blood glucose (BG) using a home glucose meter approximately every 20 minutes for 5 hours. Subjects will be asked to take one gram of acetaminophen orally on days 3, 5, and 6 of sensor wear.
On day 11, devices will be removed, data uploaded from the study meter and transmitter or recorder, skin assessment will be performed, and the subject's participation in the study will be completed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices - Phase 3 Group|
|Actual Study Start Date :||July 29, 2019|
|Actual Primary Completion Date :||August 27, 2019|
|Actual Study Completion Date :||August 27, 2019|
Experimental: Subjects Wearing Guardian Sensor (3)s
Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear.
Device: Guardian Sensor (3)
Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
- Accuracy of Sensor Glucose Before and After Acetaminophen Administration [ Time Frame: Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported ]
Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm).
Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) * 100).
Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).
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): NCT04020822
|United States, Colorado|
|Barbara Davis Center for Diabetes|
|Aurora, Colorado, United States, 80045|
|United States, Georgia|
|Atlanta Diabetes Associates|
|Atlanta, Georgia, United States, 30318|