NCT05833100

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)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: i-SENS, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	CareSens PRO GK Blood Glucose/b-Ketone Monitoring system	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.

Timeline

• Start date: 2022-08-15
• Primary completion: 2022-09-26
• Completion: 2023-02-23
• First posted: 2023-04-27
• Last updated: 2024-02-29
• Results posted: 2024-02-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study