Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2023-02-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Ketoacidosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Stepped wedge control trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Use of CareSens ketone meter

Intervention Type OTHER

Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

* Previously recruited to study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes