KARMA2

Use of blood ketone meters to improve ambulance hyperglycaemia care

What is KARMA2?

KARMA2 is a feasibility study which is looking to see whether ambulance clinicians can reliably and safely identify diabetic ketoacidosis using blood ketone meters, and start fluid therapy, and determine whether a full-scale clinical trial is warranted.

Why is this important?

Diabetic ketoacidosis (DKA) is a potentially life-threatening condition associated with diabetes, certain medications, and other health conditions. It is caused by the build-up of ketones in the body and requires immediate treatment. Hospital guidelines recommend immediately starting intravenous fluid therapy on diagnosis. This does not routinely happen in the ambulance setting because ambulance clinicians do not have access to blood ketone meters, and they rely on non-specific clinical signs and symptoms for care strategies.

What will we be doing?

Using a stepped-wedge study design, East of England Ambulance Service NHS Trust (EEAST) clinicians will consent 800 adult patients with hyperglycaemia (raised blood glucose) and unwell patients with diabetes.

During an initial 4-month control period, 400 participants will receive usual ambulance care. Then, during a 4-month intervention period, a further 400 participants will receive usual care and a blood ketone assessment, using a finger-prick blood test. Those with raised ketone levels and at high risk of DKA will receive intravenous fluid (saline) therapy and be taken to hospital. For patients not requiring hospital care, we will advise their GP of their participation in KARMA2.

In addition, we will be interviewing twenty ambulance and hospital study clinicians to explore their experiences of hyperglycaemic and DKA patient care and ambulance ketone meter use.

Getting involved:

Frontline emergency ambulance clinicians (paramedics and non-paramedics) working from Cambridge, Huntingdon, and Peterborough ambulance stations are eligible to participate in KARMA2.

If you are an EEAST clinician and would like further information about this study, please contact the study team via research@eastamb.nhs.uk

Funding: This study has received funding from Diabetes UK (Reference ID: 20/0006180)

Trial registration: NCT04940897

Research Ethics Committee Approval: This study has been given a favourable opinion by the North East - Newcastle & North Tyneside 2 Research Ethics Committee (REC ID: 21/NE/0134)

Study start date: 1st September 2021