CareSens Air

CGM Device Guide – Coming Soon

CareSens Air

CareSens Air is on the threshold of full inclusion in this guide. It has non-adjunctive CE and UKCA marking, 15-day wear, and published accuracy data. What it is waiting on is published evidence that meets the DSNFUK data sufficiency threshold. That data is expected soon.

CGM Coming soon

Current status

Framework criteriaMet
Data sufficiency thresholdPending – final published evidence under review
CE markingNon-adjunctive, 18 years and older
UKCA / MHRAUpdated – non-adjunctive confirmed (DSNFUK correspondence, May 2025)
Published MARD10.42% (Diabetes Technology and Therapeutics, 2024)
Wear duration15 days
CalibrationOptional (algorithm updated 2024/25 – confirm current guidance with Spirit Health)
AID compatibleNot confirmed
UK distributorSpirit Health (Leicester)
Manufactureri-SENS Inc. (South Korea)

Why it is not a full page yet

CareSens Air meets the five-criteria framework. It has a non-adjunctive CE and UKCA mark. It has published accuracy data from a 15-day trial. The reason it does not yet have a full device page in this guide is that the DSNFUK framework requires published data that meets the minimum data sufficiency threshold – enough participants with enough paired measurements to be confident the accuracy figures are generalisable.

The off-the-record data from ATTD 2026 is encouraging. When that data is published in peer-reviewed form, this page will be upgraded to a full device page immediately.

What we know

CareSens Air is a 15-day CGM manufactured by i-SENS in South Korea and distributed in the UK by Spirit Health. It entered UK prescribing – including FP10 in some ICBs – in 2024/25.

The published 15-day accuracy study (Diabetes Technology and Therapeutics, 2024) reports an overall MARD of 10.42% – 10.62% in type 1 diabetes, 9.85% in type 2. The Parkes error grid data and full study detail will be included in the device page on upgrade.

A calibration algorithm update in 2024/25 reduced mandatory calibration frequency and introduced an optional calibration mode. Current calibration guidance should be confirmed with Spirit Health before clinical use.

When this page will be updated

This page will be upgraded to a full device page when published accuracy data meets the DSNFUK 5/5 framework sufficiency threshold. No date is confirmed – it depends on publication timing. We are in contact with Spirit Health on this and will update as soon as the evidence is available.

If you are a clinician or patient making a prescribing decision about CareSens Air now, the published MARD of 10.42% and the non-adjunctive CE/UKCA marking are the currently available clinical data points. Contact Spirit Health for the most up-to-date evidence package.

Spirit Health UK contact: Clare Leek – Clare.Leek@spirit-health.com