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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000964314
Ethics application status
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Approved
Date submitted
Help: Date submitted
6/07/2026
Date registered
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6/08/2026
Date last updated
Help: Date last updated
6/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
6/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Understanding Changes in Blood Sugar and Ketone Levels in Hospitalised Patients with or at Risk of Diabetic Ketoacidosis
Scientific title
Profiling Glucose and Ketone Levels in Hospitalised Patients Admitted with Diabetic Ketoacidosis or at Risk of Diabetic Ketoacidosis (PROFILE-DKA)
Additional trial identifiers [1] 317531 0
None
Universal Trial Number (UTN)
Trial acronym
PROFILE-DKA
Related trial records

Health condition
Health condition(s) studied:
Diabetic ketoacidosis 342161 0
Type 1 diabetes 342164 0
Type 2 diabetes 342165 0
Condition category
Condition code
Metabolic and Endocrine 338281 338281 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Multi-site, blinded study, evaluating glucose and ketone profiles using the SiBionics Continuous Glucose and Ketone Monitor (CGKM). The CGKM is oval-shaped and is 24.8mm x 17.8mm x 2.9 mm in size. It will be inserted on the back of the upper arm. It will be inserted and removed by research study staff who have been appropriately trained and delegated on the study delegation log.

Two cohorts will be enrolled:
Cohort 1 includes at least 50 adults with type 1 diabetes (T1D) or type 2 diabetes (T2D) admitted to hospital with a clinical diagnosis of diabetic ketoacidosis (DKA).
Cohort 2 includes at least 100 adults with T1D admitted for an acute illness without DKA.
Following consent, a blinded/masked study CGKM will be inserted as close as possible to hospital presentation and worn throughout the inpatient admission to collect glucose and ketone data. Fidelity to intervention procedures will be monitored in hospital by reviewing in-person the CGKM is still in place or by auditing patient medical or nursing notes.

On the day of discharge, for both cohorts, participants will have a new SiBionics CGKM inserted to wear for 14 days post-discharge, after which they will resume their pre-study standard care. The CGKM will be inserted prior to discharge home by research study staff who have been appropriately trained and delegated on the study delegation log. Participants will be provided instructions on how to remove the CGKM after 14 days post-discharge. Adherence to the CGKM inserted on the day of discharge after discharge home will not be assessed.

Cohort-specific analysis will be performed separately for Cohort 1 and Cohort 2. Further outcome analyses will be undertaken where participants from Cohort 1 with type 1 diabetes and participants from Cohort 2 will be combined to form a larger type 1 diabetes group.
Intervention code [1] 334262 0
Treatment: Devices
Description of the comparator or control
All participants will be transferred to the investigational device the SiBionics Continuous Glucose and Ketone Monitor (CGKM), for which glucose and ketone data from the device will be blinded to the participant and treating healthcare team. All participants will be managed as per routine clinical care by their treating healthcare team.

Routine clinical care is defined as investigations and treatment performed as per the usual treating medical team. This will include capillary blood glucose and capillary blood ketone finger-prick testing, for which the frequency will be decided by the treating medical team as per usual clinical care.
Control group
Active

Outcomes
Primary outcome [1] 345633 0
Cohort 1: Incidence (%) of re-emergence of ketosis (defined as a rise in ketone levels to >1.5mmol/L) while in hospital after ketone levels have fallen to <0.6mmol/L following admission
Timepoint [1] 345633 0
From time of hospital presentation until discharge from hospital
Primary outcome [2] 345634 0
Cohort 2: Proportion of time (%) spent with ketone levels > 1.5mmol/L
Timepoint [2] 345634 0
From time of hospital presentation until discharge from hospital
Primary outcome [3] 346372 0
Validity of ketone data collected from the SiBionics CGKM from both cohorts 1 and 2
Timepoint [3] 346372 0
From time of hospital presentation until discharge from hospital
Secondary outcome [1] 462601 0
Cohort 1: Number of episodes of re-emergent DKA (DKA criteria met while hospitalised after DKA associated with presentation has resolved)
Timepoint [1] 462601 0
From time of hospital presentation until discharge from hospital
Secondary outcome [2] 462602 0
Cohort 1: Peak ketone levels (mmol/L) associated with re-emergent ketosis
Timepoint [2] 462602 0
From time of hospital presentation until discharge from hospital
Secondary outcome [3] 462603 0
Cohort 1: Time (mins) between DKA resolution and re-emergent ketosis
Timepoint [3] 462603 0
From time of hospital presentation until discharge from hospital
Secondary outcome [4] 462604 0
Cohort 1: Time (mins) to normalisation of CGKM ketone levels (<0.6mmol/L) from hospital presentation
Timepoint [4] 462604 0
From time of hospital presentation until discharge from hospital
Secondary outcome [5] 462630 0
Cohort 1: Time (mins) to normalisation of CGKM glucose levels (<10.0mmol/L) from hospital presentation
Timepoint [5] 462630 0
From time of hospital presentation until discharge from hospital
Secondary outcome [6] 462631 0
Cohort 1: Time (mins) to normalisation of acidosis (pH >7.30) on blood gas measurement from hospital presentation
Timepoint [6] 462631 0
From time of hospital presentation until discharge from hospital
Secondary outcome [7] 463041 0
Cohort 1: Percent time spent in prespecified ketone ranges provided by the CGKM
Timepoint [7] 463041 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [8] 463042 0
Cohort 1: Number of episodes of severe hypoglycaemia
Timepoint [8] 463042 0
From time of hospital presentation until discharge from hospital
Secondary outcome [9] 463043 0
Cohort 1: Length of hospital stay (days)
Timepoint [9] 463043 0
From time of hospital presentation until discharge from hospital
Secondary outcome [10] 463044 0
Cohort 1: Percentage of patients presenting to the hospital with DKA who were recruited for the study
Timepoint [10] 463044 0
From time of hospital presentation until discharge from hospital
Secondary outcome [11] 463045 0
Cohort 1: Percentage of participants recruited for the study who received a CGKM within 6 hours of presentation
Timepoint [11] 463045 0
Six hours of presentation to hospital
Secondary outcome [12] 463046 0
Cohort 1: Percentage time post-CGKM insertion until discharge from hospital that data were available
Timepoint [12] 463046 0
From time of CGKM insertion until discharge from hospital, time of hospital discharge will be confirmed from hospital records
Secondary outcome [13] 463047 0
Cohort 1: Mean duration of CGKM wear
Timepoint [13] 463047 0
From time of CGKM insertion until discharge from hospital
Secondary outcome [14] 463048 0
Cohort 1: Number of adverse reactions to CGKM
Timepoint [14] 463048 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [15] 463049 0
Cohort 1: Mean difference between capillary blood glucose levels and CGKM glucose levels
Timepoint [15] 463049 0
From time of hospital presentation until discharge from hospital
Secondary outcome [16] 463050 0
Cohort 1: Patient user experience satisfaction of CGKM
Timepoint [16] 463050 0
Questionnaire to be completed on day of discharge
Secondary outcome [17] 463051 0
Cohort 2: Peak ketone levels (mmol/L) during hospital stay
Timepoint [17] 463051 0
From time of hospital presentation until discharge from hospital
Secondary outcome [18] 463052 0
Cohort 2: Number of episodes of emergent DKA (DKA criteria met while hospitalised after initial admission without DKA)
Timepoint [18] 463052 0
From time of hospital presentation until discharge from hospital
Secondary outcome [19] 463053 0
Cohort 2: Percent time spent in prespecified ketone ranges provided by the CGKM
Timepoint [19] 463053 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [20] 463054 0
Cohort 2: Number of episodes of severe hypoglycaemia
Timepoint [20] 463054 0
From time of hospital presentation until discharge from hospital
Secondary outcome [21] 463055 0
Cohort 2: Length of hospital stay (days)
Timepoint [21] 463055 0
From time of hospital presentation until discharge from hospital
Secondary outcome [22] 463056 0
Cohort 2: Percentage of patients with T1D admitted to the hospital with an acute illness who were recruited for the study
Timepoint [22] 463056 0
From time of hospital presentation until discharge from hospital
Secondary outcome [23] 463057 0
Cohort 2: Percentage of participants recruited for the study who received a CGKM within 6 hours of presentation
Timepoint [23] 463057 0
Six hours of presentation to hospital
Secondary outcome [24] 463058 0
Cohort 2: Percentage time post-CGKM insertion until discharge from hospital that data were available
Timepoint [24] 463058 0
From time of CGKM insertion until discharge from hospital
Secondary outcome [25] 463059 0
Cohort 2: Mean duration of CGKM wear
Timepoint [25] 463059 0
From time of hospital presentation until discharge from hospital
Secondary outcome [26] 463060 0
Cohort 2: Number of adverse reactions to CGKM
Timepoint [26] 463060 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [27] 463061 0
Cohort 2: Mean difference between capillary blood glucose levels and CGKM glucose levels
Timepoint [27] 463061 0
From time of hospital presentation until discharge from hospital
Secondary outcome [28] 463062 0
Cohort 2: Patient user experience satisfaction of CGKM
Timepoint [28] 463062 0
Questionnaire to be completed on day of discharge
Secondary outcome [29] 465104 0
Cohort 1: Percent time spent in prespecified glucose ranges and glucose metrics provided by the CGKM
Timepoint [29] 465104 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [30] 465105 0
Cohort 1: Mean difference between capillary blood ketone levels and CGKM ketone levels
Timepoint [30] 465105 0
From time of hospital presentation until discharge from hospital
Secondary outcome [31] 465106 0
Cohort 1: Clinician user experience satisfaction of CGKM
Timepoint [31] 465106 0
Questionnaire to be completed on day of discharge
Secondary outcome [32] 465109 0
Cohort 2: Percent time spent in prespecified glucose ranges and glucose metrics provided by the CGKM
Timepoint [32] 465109 0
From time of CGKM insertion until 14 days after discharge from hospital
Secondary outcome [33] 465113 0
Cohort 2: Mean difference between capillary blood ketone levels and CGKM ketone levels
Timepoint [33] 465113 0
From time of hospital presentation until discharge from hospital
Secondary outcome [34] 465114 0
Cohort 2: Clinician user experience satisfaction of CGKM
Timepoint [34] 465114 0
Questionnaire to be completed on day of discharge

Eligibility
Key inclusion criteria
Cohort 1:
*Age 18 years of age and over
*Clinically diagnosed with T1D or T2D
*Meet the criteria for DKA
*Admitted to hospital as an inpatient.

Cohort 2:
*Aged 18 years of age and over
*Clinically diagnosed with T1D
*Admitted to hospital as an inpatient under medicine or surgery.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Cohorts 1 and 2:
*Pregnant women
*Severe tape allergy
*Clinically diagnosed with delirium
*Cognitive impairment
*Major medical or psychiatric illness that would interfere with protocol adherence
*Individuals unable to read, speak, or understand English to a level of understanding of the PICF, or those for whom translation services/certified translated documents are not available
*Any other reason that in the opinion of the investigator would prevent the subject from completing study procedures

Cohort 2 Only:
*Admitted under Day Stay, Short Stay and Hospital in The Home
*Diagnosis of DKA .

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Other
Other design features
There will be two cohorts in which all participants will receive the same SiBionics CGKM. On the day of discharge, all participants will have another SiBionics CGKM inserted.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/08/2026
Actual
Date of last participant enrolment
Anticipated
2/07/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC
Recruitment hospital [1] 29573 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 29574 0
The Canberra Hospital - Garran
Recruitment hospital [3] 29576 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [4] 29577 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 29578 0
Werribee Mercy Hospital - Werribee
Recruitment hospital [6] 29870 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 45902 0
3065 - Fitzroy
Recruitment postcode(s) [2] 45903 0
2605 - Garran
Recruitment postcode(s) [3] 45905 0
3084 - Heidelberg
Recruitment postcode(s) [4] 45906 0
3050 - Parkville
Recruitment postcode(s) [5] 45907 0
3030 - Werribee
Recruitment postcode(s) [6] 46225 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 322033 0
Commercial sector/Industry
Name [1] 322033 0
In-kind support provided by SiBionics - provision of CGKM devices
Country [1] 322033 0
Australia
Funding source category [2] 322582 0
Hospital
Name [2] 322582 0
St Vincent's Hospital (Public) Melbourne
Country [2] 322582 0
Australia
Funding source category [3] 322583 0
Hospital
Name [3] 322583 0
Canberra Hospital
Country [3] 322583 0
Australia
Funding source category [4] 322586 0
Hospital
Name [4] 322586 0
St Vincent's Hospital Sydney
Country [4] 322586 0
Australia
Funding source category [5] 322587 0
Hospital
Name [5] 322587 0
The Austin Hospital
Country [5] 322587 0
Australia
Funding source category [6] 322588 0
Hospital
Name [6] 322588 0
The Royal Melbourne Hospital
Country [6] 322588 0
Australia
Funding source category [7] 322589 0
Hospital
Name [7] 322589 0
Werribee Mercy Hospital
Country [7] 322589 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital (Public) Melbourne
Address
Country
Australia
Secondary sponsor category [1] 324982 0
None
Name [1] 324982 0
Address [1] 324982 0
Country [1] 324982 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320564 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 320564 0
Ethics committee country [1] 320564 0
Australia
Date submitted for ethics approval [1] 320564 0
02/03/2026
Approval date [1] 320564 0
03/07/2026
Ethics approval number [1] 320564 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 150894 0
Prof David O'Neal
Address 150894 0
St Vincent's Hospital Melbourne, Level 4, Clinical Sciences Building, 29 Victoria Parade, Fitzroy, VIC, 3065
Country 150894 0
Australia
Phone 150894 0
+61425731665
Fax 150894 0
Email 150894 0
[email protected]
Contact person for public queries
Name 150895 0
Dr Cherie Choong
Address 150895 0
St Vincent's Hospital Melbourne, Level 4, Clinical Sciences Building, 29 Victoria Parade, Fitzroy, VIC, 3065
Country 150895 0
Australia
Phone 150895 0
+61 03 9231 2757
Fax 150895 0
Email 150895 0
[email protected]
Contact person for scientific queries
Name 150896 0
David O'Neal
Address 150896 0
St Vincent's Hospital Melbourne, Level 4, Clinical Sciences Building, 29 Victoria Parade, Fitzroy, VIC, 3065
Country 150896 0
Australia
Phone 150896 0
+61 03 9231 2757
Fax 150896 0
Email 150896 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.