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

Primary Purpose

Diabetic Ketoacidosis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Use of CareSens ketone meter
Sponsored by
East of England Ambulance Service NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Ketoacidosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • East of England Ambulance Service NHS Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 25, 2021
Last Updated
February 23, 2023
Sponsor
East of England Ambulance Service NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT04940897
Brief Title
Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care
Acronym
KARMA2
Official Title
Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
February 23, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East of England Ambulance Service NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Ketoacidosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Stepped wedge control trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Usual care plus ketone meter and fluid therapy for identified high risk DKA patients
Intervention Type
Other
Intervention Name(s)
Use of CareSens ketone meter
Intervention Description
Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA
Primary Outcome Measure Information:
Title
Measure incidence of hyperglycaemia in study population
Description
Frequency count of capillary blood glucose level greater than 11mmol/L
Time Frame
18 months
Title
Measure incidence of diabetic ketoacidosis (DKA) in study population
Description
Frequency count of capillary blood ketone level equal to or greater than 3mmol/L
Time Frame
18 months
Title
Completeness of data capture by study clinicians
Description
Progression criteria requires full record completion for a minimum of 70 percent of participants
Time Frame
18 months
Title
Measure incidence of adverse events
Description
Progression criteria requires adverse event rate to be less than 1 percent of participants
Time Frame
Maximum 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Davis
Organizational Affiliation
East of England Ambulance Service NHS Trust
Official's Role
Study Director
Facility Information:
Facility Name
East of England Ambulance Service NHS Trust
City
Melbourn
State/Province
Cambs
ZIP/Postal Code
SG8 6EN
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care

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