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

Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Ketoacidosis
• Intervention / Treatment: Other: Use of CareSens ketone meter

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 Type: Interventional
• Enrollment (Actual): 420
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Cambs
    • Melbourn, Cambs, United Kingdom, SG8 6EN
      • East of England Ambulance Service NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Usual care plus ketone meter and fluid therapy for identified high risk DKA patients	Other: Use of CareSens ketone meter; Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: East of England Ambulance Service NHS Trust
• Investigators: Study Director: Tom Davis, East of England Ambulance Service NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2021
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: May 25, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Acid-Base Imbalance; Acidosis; Ketosis; Diabetic Ketoacidosis
• Other Study ID Numbers: KARMA2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No