This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.
Participants will wear two CareSens Air 3 and one Libre 3 Plus for 16 days without access to glucose values from the CareSens Air 3 devices while maintaining their original diabetes mellitus treatment. The participants will draw capillary blood at least 8 times a day using the SMBG system between study visits. Between insertion and removal of the CareSens Air 3 the participants will be in the clinic 4 times to obtain accurate glucose reading from the reference device under carefully controlled circumstances including induction of low and high blood glucose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Enrollment
32
Primary CareSens Air 3 device
Secondary CareSens Air 3 device
Headlands Research AMCR
Escondido, California, United States
NOT_YET_RECRUITINGDiablo Clinical Research
Walnut Creek, California, United States
RECRUITINGAtlanta Diabetes Associates
Atlanta, Georgia, United States
NOT_YET_RECRUITINGAccuracy of the glucose concentration measurements
percentage of iCGM values in the measuring range less than 70 mg/dL (3.9 mmol/l) within +/- 15 mg/dL (0.83 mmol/l) of the reference venous glucose measurement by YSI analyzer
Time frame: 16 days
Precision of the glucose measurements
Precision (absolute relative difference between simultaneous measurements between two CGM devices)
Time frame: 16 days
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Rainier Clinical Reseach Center
Renton, Washington, United States
RECRUITING