Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System

Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System (CareSens PRO GK BT)

The goal of this clinical trial is to assess the accuracy and usability of the blood glucose meter in untrained participants, both with or without diabetes, as well as those with pre-diabetes.

Participants will personally date and sign the informed consent before engaging in any study-related activity. Participants use a single-use lancing device to lance their finger and perform a blood glucose test with glucose test strips on the meter. Trained staff collects more blood samples for YSI and hematocrit measurement (approx. 300-350μL) using a specified lancet within 5 minutes of the first evaluable meter reading. Follow the same process to measure Ketones using the β-Ketone test strip on the same meter. The staff collects more blood samples for Imola and hematocrit measurement (approx. 500-550μL).

After subjects have completed the testing, they are then asked to complete usability questionnaires.

Inclusion Criteria:

• Males and females, 18 years of age and older
• People with type 1 diabetes, type 2 diabetes, pre-diabetes and no diabetes (self- reported)
• Able to speak, read and understand English (subjects must demonstrate ability to read a sentence from a page of the draft device labeling instructions (user's manual) to qualify for the study)
• Willing to complete all study procedures
• Has read, understood, and signed the Informed Consent Form

Note: The study group consists of naive SMBG users and non-naive SMBG users. At least 10% of study participants should be naive for SMBG, including subjects without diabetes.

Exclusion Criteria:

• Hemophilia or any other bleeding disorder
• Works for a medical laboratory, hospital, other clinical setting or a medical device company that involves training on or clinical use of blood glucose meters
• Physical, visual or neurological impairments as determined by the investigator or designee that would make the subject unable to perform self-testing (reason for exclusion will be clearly documented by investigator or designee directly on the subject disposition form)
• A condition, which in the opinion of the investigator or designee, would put the subject or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee on the subject disposition form).

Note 1: In the event of a physical, visual or neurological impairment that makes it difficult for a subject to complete the questionnaire, the subject's verbal responses will be accepted and should be appropriately documented as such within the subject records form.