Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

Not Applicable

Completed

• Conditions: Diabetic Ketoacidosis
• Interventions: Other: Use of CareSens ketone meter

• Registration Number: NCT04940897
• Lead Sponsor: East of England Ambulance Service NHS Trust

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.

Study Timeline

• Study First Submitted: 2021-05-25
• Study First Submitted QC: 2021-06-18
• Study First Posted: 2021-06-28
• Study Start: 2021-10-25
• Primary Completion: 2022-09-30
• Status Verified: 2023-02
• Study Completion: 2023-02-23
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Use of CareSens ketone meter	Usual care plus ketone meter and fluid therapy for identified high risk DKA patients

Primary Outcome Measures

Name	Time	Method
Measure incidence of hyperglycaemia in study population	18 months	Frequency count of capillary blood glucose level greater than 11mmol/L
Measure incidence of diabetic ketoacidosis (DKA) in study population	18 months	Frequency count of capillary blood ketone level equal to or greater than 3mmol/L
Completeness of data capture by study clinicians	18 months	Progression criteria requires full record completion for a minimum of 70 percent of participants
Measure incidence of adverse events	Maximum 18 months	Progression criteria requires adverse event rate to be less than 1 percent of participants

Trial Locations

Locations (1)

East of England Ambulance Service NHS Trust; 🇬🇧 Melbourn, Cambs, United Kingdom