Clinical trial NCT04940897: Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care
Official title: Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Ketoacidosis
Lead sponsor: East of England Ambulance Service NHS Trust
Sponsor class: OTHER_GOV
First posted: 2021-06-28
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stepped wedge control trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure incidence of hyperglycaemia in study population
timeFrame: 18 months
measure: Measure incidence of diabetic ketoacidosis (DKA) in study population
timeFrame: 18 months
measure: Completeness of data capture by study clinicians
timeFrame: 18 months
measure: Measure incidence of adverse events
timeFrame: Maximum 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourn
country: United Kingdom
facility: East of England Ambulance Service NHS Trust
state: Cambs
Study officials:
affiliation: East of England Ambulance Service NHS Trust
name: Tom Davis
role: STUDY_DIRECTOR
References: