Diabetic KetoacidosisKARMA2NCT04940897
Use of Blood Ketone Meters to Improve Ambulance Hyperglycaemia Care
A study testing Use of CareSens ketone meter in people with Diabetic Ketoacidosis, run by East of England Ambulance Service NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Ketoacidosis
- What is being tested?
- Use of CareSens ketone meter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Oct 2021to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Failure to meet inclusion criteria
- Previously recruited to study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East of England Ambulance Service NHS Trust
Melbourn, Cambs, SG8 6EN
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetic Ketoacidosis
- Being tested
- Use of CareSens ketone meter
- Medical subject headings
- Diabetic Ketoacidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of CareSens ketone meterOther
Use of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Usual care plus ketone meter and fluid therapy for identified high risk DKA patients Receives: Other: Use of CareSens ketone meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure incidence of hyperglycaemia in study population
Frequency count of capillary blood glucose level greater than 11mmol/L
Measured: 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
Measured: 18 months
Completeness of data capture by study clinicians
Progression criteria requires full record completion for a minimum of 70 percent of participants
Measured: 18 months
Measure incidence of adverse events
Progression criteria requires adverse event rate to be less than 1 percent of participants
Measured: Maximum 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start25 Oct 2021
- Primary completion30 Sep 2022
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic KetoacidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Stepped wedge control trial
- Masking
- None (open label)
- Enrolment
- 420 participants (actual)
Sponsor and investigators
- Lead sponsor
- East of England Ambulance Service NHS Trust
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Theresa Foster, East of England Ambulance Service NHS Trust
- Investigators
- Tom Davis, Study director, East of England Ambulance Service NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940897
- Sponsor's protocol ID
- KARMA2
- Acronym
- KARMA2
- Status last verified
- Feb 2023
- First submitted
- 25 May 2021
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38853420
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Capillary Blood Ketone Meters to Improve Ambulance Service Care of Hyperglycaemic Patients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04940897
- Acronym / sponsor ID
- KARMA2 / KARMA2
- Conditions
- Diabetic Ketoacidosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- East of England Ambulance Service NHS TrustOther government
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 28 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Stepped wedge control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Use of CareSens ketone meterUsual care plus ketone meter and fluid therapy for identified high risk DKA patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Failure to meet inclusion criteria
- Previously recruited to study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of CareSens ketone meterUse of CareSens ketone meter to identify blood ketone levels and delivery of fluid therapy to those patients at high risk of DKA | Other | Intervention |
Primary outcome
Measure incidence of hyperglycaemia in study population
Time frame: 18 months
Frequency count of capillary blood glucose level greater than 11mmol/L
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
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
Measure incidence of adverse events
Time frame: Maximum 18 months
Progression criteria requires adverse event rate to be less than 1 percent of participants
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Derived from this study: PubMed 38853420Prothero 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.
- Individual participant dataSharing planned: No
Related trials for Diabetic Ketoacidosis
Not yet recruitingPhase 1/2
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAL-119 in Healthy Volunteers and Adult Participants With Type 1 or Type 2 Diabetes
Healthy Volunteers and Diabetes Participants
Not yet recruitingPhase 2
Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.
Type 1 Diabetes Mellitus, Chronic Kidney Disease (CKD) With Diabetes Mellitus (DM)
RecruitingObservational study
The Real-World Control-IQ Glycemic Control and Quality of Life Study in Type 1 Diabetes in France
Diabetes Mellitus, Type 1
RecruitingObservational study
Perfusion Index for Predicting Diabetic Ketoacidosis Severity in the Emergency Department
Diabetic Ketoacidosis
Not yet recruitingObservational study
Leukocyte Glucose Index and Severity of Diabetic Ketoacidosis
Diabetic Ketoacidosis, Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Davis study director
East of England Ambulance Service NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of CareSens ketone meter in people with Diabetic Ketoacidosis, run by East of England Ambulance Service NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure incidence of hyperglycaemia in study population (time frame: 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04940897, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.