Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001193369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
1/07/2026
Date registered
Help: Date registered
24/09/2026
Date last updated
Help: Date last updated
24/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
24/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Rates of Diabetic Ketoacidosis with Dapagliflozin in Adults with Type 1 Diabetes Using Continuous Ketone Monitoring
Scientific title
Prevention of Diabetic Ketoacidosis Using Continuous Ketone Monitoring
in Adults with Type 1 Diabetes Receiving Dapagliflozin
Additional trial identifiers [1] 317729 0
Nil
Universal Trial Number (UTN)
Trial acronym
PREVENT-DKA
Related trial records
ACTRN12624000448549 - follow up. Participants who were previously enrolled in the PARTNER study will be recruited as the participant cohort into this study

Health condition
Health condition(s) studied:
Type 1 diabetes 342617 0
Diabetic ketoacidosis 342618 0
Condition category
Condition code
Metabolic and Endocrine 338770 338770 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Following informed consent by participants, study team members face to face will assist the participants with the insertion of the study device on the back of the upper arm. The continuous glucose/ketone monitor (CGKM, SiBionics) uses an all-in-one applicator that inserts the sensor and the applicator is then discarded. The CGKM is able to remain inserted and collect data for up to 15 days. The study team members will then provide a 30 minute education session which provides information and teach participants how to change and self-apply the CGKM device themselves as well as use the study device and mobile app.
Participants will wear a CGKM device for six months over the study period, with the CGKM being changed by the participant at home every 15 days. The study CGKM will operate in a partially blinded (masked) mode, whereby ketone data will be visible to participants while glucose data will remain masked. Participants will continue to use their personal continuous glucose monitor (CGM) for routine glucose management and their current Dapagliflozin therapy (10mg/day) throughout the six-month study period. Participants will be monitored remotely on a monthly basis for the six-month study period where CGKM device data will be reviewed to check for adherence.
Intervention code [1] 334595 0
Treatment: Devices
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345997 0
Number of episodes of diabetic ketoacidosis (DKA) requiring hospital presentation (emergency department) or admission (inpatient). This will be assessed as a composite outcome.
Timepoint [1] 345997 0
Throughout the study (6 months)
Secondary outcome [1] 464072 0
Percent (%) time with ketone levels >1.5 mmol/L on continuous ketone monitor (CKM)
Timepoint [1] 464072 0
Throughout the study (6 months)
Secondary outcome [2] 464073 0
Percent (%) time with ketone levels 3.0 mmol/L or above on continuous ketone monitor (CKM)
Timepoint [2] 464073 0
Throughout the study (6 months)
Secondary outcome [3] 464074 0
Number of episodes with critically high CKM ketone levels 3.0 mmol/L or above
Timepoint [3] 464074 0
Throughout the study (6 months)
Secondary outcome [4] 464075 0
Comparison of frequency of elevated ketones >1.5 mmol/L between fasting state (12 midnight to 6:00) and non-fasting state (10:00– 22:00)
Timepoint [4] 464075 0
Throughout the study (6 months)
Secondary outcome [5] 464076 0
Comparison of frequency of elevated ketones 3.0 mmol/L or above between fasting state (12 midnight to 6:00) and non-fasting state (10:00– 22:00)
Timepoint [5] 464076 0
Throughout the study (6 months)
Secondary outcome [6] 464077 0
Change in weight
Timepoint [6] 464077 0
At baseline and end of the study (6-months post intervention)
Secondary outcome [7] 464078 0
Change in blood pressure
Timepoint [7] 464078 0
At baseline and end of the study (6-months post intervention)
Secondary outcome [8] 464079 0
Rate of discontinuation of Dapagliflozin
Timepoint [8] 464079 0
Throughout the study (6 months)
Secondary outcome [9] 464080 0
Reasons for discontinuation of Dapagliflozin
Timepoint [9] 464080 0
Throughout the study (6 months)
Secondary outcome [10] 464081 0
Time in Range (TIR) 3.9 - 10 mmol/L
Timepoint [10] 464081 0
Throughout the study (6 months)
Secondary outcome [11] 464082 0
Time Below Range (TBR) 3.0 - 3.8 mmol/L
Timepoint [11] 464082 0
Throughout the study (6 months)
Secondary outcome [12] 464083 0
Time Below Range (TBR) <3.0 mmol/L
Timepoint [12] 464083 0
Throughout the study (6 months)
Secondary outcome [13] 464084 0
Time Above Range (TAR) 10.1 - 13.9 mmol/L
Timepoint [13] 464084 0
Throughout the study (6 months)
Secondary outcome [14] 464085 0
Time Above Range (TAR) >13.9 mmol/L
Timepoint [14] 464085 0
Throughout the study (6 months)
Secondary outcome [15] 464086 0
Glucose Management Indicator (GMI)
Timepoint [15] 464086 0
Throughout the study (6 months)
Secondary outcome [16] 464088 0
Glycaemic variability as assessed by Coefficient of Variation (%CV)
Timepoint [16] 464088 0
Throughout the study (6 months)
Secondary outcome [17] 464090 0
Average glucose level
Timepoint [17] 464090 0
Throughout the study (6 months)

Eligibility
Key inclusion criteria
- Aged 18 years of age and over
- Clinically diagnosed with T1D for more than one year
- Participated in the PARTNER study (ACTRN12624000448549)
- Currently using Dapagliflozin (10mg/day)
- Have their own access blood ketone meter
- Compatible mobile phone to download and use with SiBionics GK5 app
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
- Pregnant women or planned pregnancy
- 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.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC

Funding & Sponsors
Funding source category [1] 322273 0
Hospital
Name [1] 322273 0
In-kind support from study site - St Vincent's Hospital (Public) Melbourne
Country [1] 322273 0
Australia
Funding source category [2] 322302 0
Commercial sector/Industry
Name [2] 322302 0
SiBionics
Country [2] 322302 0
China
Funding source category [3] 323040 0
Hospital
Name [3] 323040 0
In-kind support from study site - Royal Melbourne Hospital
Country [3] 323040 0
Australia
Funding source category [4] 323041 0
Hospital
Name [4] 323041 0
In-kind support from study site - Southern Adelaide Diabetes and Endocrinology Services
Country [4] 323041 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 325220 0
None
Name [1] 325220 0
Address [1] 325220 0
Country [1] 325220 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320789 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 320789 0
Ethics committee country [1] 320789 0
Australia
Date submitted for ethics approval [1] 320789 0
25/06/2026
Approval date [1] 320789 0
19/08/2026
Ethics approval number [1] 320789 0

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

Contacts
Principal investigator
Name 151634 0
Prof David O'Neal
Address 151634 0
Diabetes Technology Research Group (D.T.R.G), Dept of Medicine Reception, L4, D41, Daly Wing North, St Vincent’s Hospital 35 Victoria Pde. Fitzroy, Victoria 3065
Country 151634 0
Australia
Phone 151634 0
+61 425731665
Fax 151634 0
Email 151634 0
[email protected]
Contact person for public queries
Name 151635 0
Dr Yee Wen Kong
Address 151635 0
Diabetes Technology Research Group (D.T.R.G), Dept of Medicine Reception, L4, D41, Daly Wing North, St Vincent’s Hospital 35 Victoria Pde. Fitzroy, Victoria 3065
Country 151635 0
Australia
Phone 151635 0
+61 3 92312757
Fax 151635 0
Email 151635 0
[email protected]
Contact person for scientific queries
Name 151636 0
Dr Yee Wen Kong
Address 151636 0
Diabetes Technology Research Group (D.T.R.G), Dept of Medicine Reception, L4, D41, Daly Wing North, St Vincent’s Hospital 35 Victoria Pde. Fitzroy, Victoria 3065
Country 151636 0
Australia
Phone 151636 0
+61 3 92312757
Fax 151636 0
Email 151636 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.