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
1 other identifier
interventional
420
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2021
CompletedFirst Posted
Study publicly available on registry
June 28, 2021
CompletedStudy Start
First participant enrolled
October 25, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2023
CompletedFebruary 24, 2023
February 1, 2023
11 months
May 25, 2021
February 23, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
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
Study Arms (1)
Intervention
EXPERIMENTALUsual care plus ketone meter and fluid therapy for identified high risk DKA patients
Interventions
Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Previously recruited to study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
East of England Ambulance Service NHS Trust
Melbourn, Cambs, SG8 6EN, United Kingdom
Related Publications (1)
Prothero LS, Strudwick T, Foster T, Lake AK, Boyle A, Clark A, Williams J, Rayman G, Dhatariya K. Ambulance clinician use of capillary blood ketone meters to improve emergency hyperglycaemia care: A stepped-wedged controlled, mixed-methods feasibility study. Diabet Med. 2024 Sep;41(9):e15372. doi: 10.1111/dme.15372. Epub 2024 Jun 9.
PMID: 38853420DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tom Davis
East of England Ambulance Service NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research
Study Record Dates
First Submitted
May 25, 2021
First Posted
June 28, 2021
Study Start
October 25, 2021
Primary Completion
September 30, 2022
Study Completion
February 23, 2023
Last Updated
February 24, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share