Clinical trial NCT05833100: Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System
Official title: Method Comparison/User Evaluation of the i-SENS Self-Monitoring Blood Glucose / β-Ketone System (CareSens PRO GK BT)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Self-Monitoring Blood Glucose (SMBG)
Lead sponsor: i-SENS, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Avania
name: Rainier Clinical Research Center
First posted: 2023-04-27
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A minimum of 350 different subjects, both naive and non-naive SMBG users, is required. At least 10% of the study participants should be naive to SMBGs and may include non-diabetic subjects.
Primary purpose: SCREENING

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hematocrit Measurement
timeFrame: 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.
Secondary outcomes:
measure: Glucose Testing of Subject Plasma Samples
timeFrame: Within 20 minuates of centrifugation
measure: β-Ketone Testing of Subject Plasma Samples
timeFrame: Within 20 minuates of centrifugation
Other outcomes:
Locations:
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
References: