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

NCT05833100 | Terminated Results FDA Device

• 1 other identifier: BGM-2205084
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Self-Monitoring Blood Glucose (SMBG)

Outcome Measures

Primary Outcomes (1)

• Hematocrit Measurement

  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.

  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 (2)

• Glucose Testing of Subject Plasma Samples

  Within 20 minuates of centrifugation

• β-Ketone Testing of Subject Plasma Samples

  Within 20 minuates of centrifugation

Study Arms (1)

Users of the Blood Glucose/b-Ketone Monitoring System

EXPERIMENTAL

Participants are individuals who have either been diagnosed with diabetes or not and are naive users of CareSens PRO GK BT.

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

Interventions

CareSens PRO GK Blood Glucose/b-Ketone Monitoring system DEVICE

All BG results were compared to YSI 2300 reference method results obtained from subjects' capillary blood. All Ketone results were compared to Randox Imola D-3-Hydroxybutyrate analyzer.

Users of the Blood Glucose/b-Ketone Monitoring System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• i-SENS, Inc.: lead
• Avania: collaborator
• Rainier Clinical Research Center: collaborator

Study Sites (1)

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Moon Hwan Kim
• Organization: i-SENS, Inc.

mhkim@i-sens.com

+82 (0)2 910 0521

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: April 27, 2023
• Study Start: August 15, 2022
• Primary Completion: September 26, 2022
• Study Completion: February 23, 2023
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)