Use of blood ketone meters to improve ambulance hyperglycaemia care
Research type
Research Study
Full title
Use of capillary blood ketone meters to improve ambulance service care of hyperglycaemic patients: a feasibility study (KARMA2 study)
IRAS ID
269289
Contact name
Larissa S Prothero
Contact email
Sponsor organisation
East of England Ambulance Service NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Diabetic ketoacidosis (DKA) is a potentially life-threatening condition associated with diabetes, certain medications, and other health conditions. Hospital-based guidelines advocate immediately starting intravenous fluid therapy upon DKA diagnosis. This does not reliably happen in the pre-hospital setting as ambulance clinicians do not routinely have access to ketone meters to determine presence of ketones. Instead, they rely on non-specific clinical signs and symptoms for care strategies. The aims of this feasibility study are to determine whether ambulance clinicians can reliably and safely identify patients with DKA using capillary blood ketone meters, commence fluid therapy, and gather necessary study data.
Using a stepped-wedge study design, 120 East of England Ambulance Service NHS Trust 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, in 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 fluid (saline) therapy. In addition, twenty ambulance and hospital study clinicians will be interviewed to explore their experiences of hyperglycaemic and DKA patient care, and ambulance ketone meter use.
Information to be collected will include clinician completion of study training, patient recruitment, intervention adherence, service call activity, and ambulance and hospital patient clinical data. Prevalence and severity of hyperglycaemia, incidence of DKA and ability of paramedics to commence fluid therapy for DKA will be explored. Quantitative findings will be analysed using descriptive statistics, whilst the qualitative study interviews will be thematically analysed.
Study findings will be used to advise the need for a large-scale, controlled trial exploring the impact of ambulance ketone meter use on the care of hyperglycaemic and unwell diabetic patients.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
21/NE/0134
Date of REC Opinion
1 Sep 2021
REC opinion
Further Information Favourable Opinion