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Completed

NCT Number: NCT04940897

Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

East of England Ambulance Service NHS Trust

Melbourn, Cambs, SG8 6EN, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of CareSens ketone meter

Other

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

Primary outcomes

  1. Measure incidence of hyperglycaemia in study population

    Time frame: 18 months

    Frequency count of capillary blood glucose level greater than 11mmol/L

  2. Measure incidence of diabetic ketoacidosis (DKA) in study population

    Time frame: 18 months

    Frequency count of capillary blood ketone level equal to or greater than 3mmol/L

  3. Completeness of data capture by study clinicians

    Time frame: 18 months

    Progression criteria requires full record completion for a minimum of 70 percent of participants

  4. Measure incidence of adverse events

    Time frame: Maximum 18 months

    Progression criteria requires adverse event rate to be less than 1 percent of participants

Sponsors and collaborators

Lead sponsor

East of England Ambulance Service NHS Trust

Other Gov

Registry information

Official study title

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

Acronym: KARMA2

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 28, 2021
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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