Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care (KARMA2)

East of England Ambulance Service NHS Trust

Status: Completed

Conditions: Diabetic Ketoacidosis

Treatments: Other: Use of CareSens ketone meter

Study type: Interventional

Funder types: Other

Identifiers

NCT04940897

KARMA2

Details and patient eligibility

About

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of diabetic ketoacidosis using blood ketone meters and start fluid (saline) therapy before arriving at hospital. The investigators aim to include 800 patients in this stepped wedge control study and the results will help decide if a larger study is warranted.

Full description

Diabetic ketoacidosis (DKA) is a potentially life-threatening condition which requires immediate treatment. National Health Service (NHS) hospital guidelines recommend immediate fluid (saline) therapy. Delays in diagnosis and treatment are known to be associated with health complications and death.

There is an opportunity to involve ambulance crews to improve DKA identification and treatment times; however, currently ambulance staff do not have access to ketone testing, and fluids are recommended only when it is thought a patient is critically unwell.

In this KARMA2 feasibility study the investigators are testing whether ambulance staff can reliably and safely identify patients at high risk of DKA using blood ketone meters and start fluid (saline) therapy before arriving at hospital.

During an 8-month period (4-month control followed by 4-month intervention), 120 ambulance clinicians from the East of England Ambulance Service NHS Trust will receive training to consent 400 patients with hyperglycaemia and unwell patients with diabetes to the control group receiving usual care, followed by determining the presence of ketones using capillary blood testing from a further 400 consenting patients with hyperglycaemia and unwell patients with diabetes. Subsequent patient care will depend on the ketone value obtained: high-risk DKA patients will receive fluid therapy.

Twenty ambulance and hospital clinicians will be invited to an online interview to share views of DKA care and the impact of ambulance blood ketone meters. The results will help the investigators decide if a larger study would be a good idea.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 18 years or more
• Attended by study clinician
• Informed or Proxy consent to participate
• Blood glucose level greater than 11mmol/L or unwell with history of diabetes
• If required will be transported to partner hospital

Exclusion criteria

• Failure to meet inclusion criteria
• Previously recruited to study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

Intervention

Experimental group

Description:

Usual care plus ketone meter and fluid therapy for identified high risk DKA patients

Treatment:

Other: Use of CareSens ketone meter