BGM and HbA1c POC Device Evaluation

Launched by FOUNDATION FOR INNOVATIVE NEW DIAGNOSTICS, SWITZERLAND · Dec 5, 2023

Keywords

ClinConnect Summary

This clinical trial is designed to evaluate how well different blood glucose meters (BGMs) and hemoglobin A1c (HbA1c) point-of-care (POC) devices perform in measuring blood sugar and hemoglobin levels in people with diabetes. The study will compare these devices to standard methods to see how accurate and user-friendly they are, especially for those who are experienced in using such devices and for those who may not be familiar with them. The aim is to ensure that these tools can be used effectively by a wide range of individuals.

To participate in this trial, you need to be between 13 and 17 years old with diabetes and able to manage your condition independently, or at least 18 years old with or without diabetes. You should also be willing to provide consent to participate and have not used the specific devices being tested in the last two years. Participants will have their blood tested using the devices, and researchers will evaluate how easy they are to use and how accurately they measure blood glucose and hemoglobin levels. This study is currently recruiting, so it's a great opportunity to contribute to diabetes research!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Arm 1:
• • 13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total Arm 1 population)
• • •≥18 years, diagnosed with diabetes
• • Able and willing to provide informed consent/assent
• • Naïve to the SMBG use of the investigational devices
• • 10% naïve to any SMBG (defined as not having performed any SMBG in the last 24 months)
• • Haematocrit within 20-60%
• • Pre-screen BGM result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range
• Arm 2:
• • •≥18 years
• • Able and willing to provide informed consent
• • Diagnosed or not diagnosed with diabetes
• • Haemoglobin values ≥ 8g/dL
• • Pre-screen HbA1c result qualifies for inclusion in the target HbA1c range and % of subjects required for the mid-range values
• Exclusion Criteria:
• Arm 1:
• • \<13 years
• • 13-17 years and not diagnosed with diabetes or unable to manage condition independently
• • Previous use of investigational BGM for SMBG
• • Haematocrit outside normal range
• • Pre-screen BGM result falling in a glucose concentration range that already has sufficient participants.
• Arm 2:
• • \<18 years
• • Haemoglobin value \< 8g/dL
• • Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.

Trial Officials