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

Not Applicable

Terminated

Conditions: Diabetes

Interventions: Device: CareSens PRO GK Blood Glucose/b-Ketone Monitoring system

Registration Number: NCT05833100

Lead Sponsor: i-SENS, Inc.

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 76

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Users of the Blood Glucose/b-Ketone Monitoring System	CareSens PRO GK Blood Glucose/b-Ketone Monitoring system	Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT.

Primary Outcome Measures

Name	Time	Method
Hematocrit Measurement	The blood sample is immediately collected for hematocrit measurement within 5 minutes of the first evaluable BG meter reading and then, centrifuge the sample within 10 minutes of sample collection.	The subject's hematocrit measurement should be within the range of 20-60% for the result to be considered evaluable. Two consecutive measurements are taken, and it determinds the analytical validity of a blood sample by the average value.

Secondary Outcome Measures

Name	Time	Method
β-Ketone Testing of Subject Plasma Samples	Within 20 minuates of centrifugation	The subject capillary plasma sample will be tested in duplicate using Rx Imola analyzer. If the measured values differ by \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L, the sample will be run a third time and the 2 average replicate readings that fall within range will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and has only a single Rx Imola value, it will be used as the Rx Imola determination. If none of the 3 average replicates fall within \> 0.075 mmol/L at ketone \< 1.5 mmol/L or \> 5% at ketone ≥ 1.5 mmol/L for readings, it will be recorded as non-evaluable.
Glucose Testing of Subject Plasma Samples	Within 20 minuates of centrifugation	The subject capillary plasma samples will be tested in duplicate. If the average of replicates 1\&2 do not fall within range (within 4% for readingsabove100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) the sample will be run a third time and the 2 average replicate readings that fall within range (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as evaluable. In general, duplicates will be averaged for each subject. If the sample is insufficient or missing and have only a single YSI value, it will be used as the YSI determination. If none of the 3 average replicates fall within (4% for readings above 100mg/dL or 4 mg/dL for samples less than or equal to 100mg/dL) will be recorded as non-evaluable. If the YSI autocals between subject sample duplicates, then another YSI 2747 standard will be run before completing the subject sample cycle.