ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12626001133325

Ethics application status

Approved

Date submitted

14/08/2026

Date registered

11/09/2026

Date last updated

11/09/2026

Date data sharing statement initially provided

11/09/2026

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluating safe ketone thresholds to minimise ketosis in young people with Type 1 Diaberes using Dapagliflozin (KETO-TRACK)

Scientific title

The Evaluation of Two Response Thresholds to Continuous Ketone Monitoring Information Minimising Ketosis in young People with Type 1 Diabetes Treated with Dapagliflozin

Additional trial identifiers [1]

Nil

Universal Trial Number (UTN)

Trial acronym

KETO-TRACK

Related trial records

NCT07225465 (ClinicalTrials.gov). This ANZCTR record represents the paediatric arm of the parent study registered on ClinicalTrials.gov. The studies share the same overarching objectives, intervention, and outcome measures, but differ in participant population, recruitment sites, and sample size. This registration has been created to separately document the paediatric cohort and is linked to the parent trial through this related trial record.

Health condition

Health condition(s) studied:

Blood glucose control

Type 1 Diabetes Mellitus

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

Dapagliflozin is a SGLT2 inhibitor (SGLT2i) with the potential to improve glycaemia but has an increased risk of diabetic ketoacidosis (DKA) even without hyperglycaemia. This study utilises a Dual Glucose and Ketone (DGK) monitor with a management plan to recognise early ketosis and intervene appropriately.
Participants aged 13-24 years with type 1 diabetes (T1D) will undertake a 2-week run-in period during which they will wear an investigational Abbott Diabetic Glucose-Ketone Monitor (DGK), comprising a continuous ketone monitor (CKM) and continuous glucose monitor (CGM), and receive standard sick-day management education. The DGK device is a wearable sensor applied to the participant's skin according to the manufacturer's instructions.

Following successful completion of the run-in period, participants will commence dapagliflozin (International Non-proprietary Name [INN]) 5 mg once daily, administered as an oral tablet, for 12 weeks in addition to their usual insulin therapy.

Participants will then be randomised 1:1 to one of two intervention groups:

Arm 1: DGK ketone alarm threshold set at 1.0 mmol/L
Arm 2: DGK ketone alarm threshold set at 1.5 mmol/L

The DGK continuously measures interstitial glucose and ketone levels and transmits readings every 5 minutes to a smartphone application. Participants in both groups will receive structured education by a Diabetes educator during the run-in period. They will also be provided with and trained in the use of a study blood glucose / ketone meter (Freestyle Optium / Precision Neo Blood Glucose Meter, Abbott Diabetes Care), which will be used for confirmatory blood glucose and ketone testing as clinically indicated. In addition, sick day education will be reinforced emphasising the review of ketone levels though no education regarding ketone threshold levels and response strategies will be provided. This education is based on the STICH protocol52 (Stop, Inject, Carbohydrate and Hydrate) principles.
Participants will be instructed to wear the DGK continuously throughout the study. Adherence will be supported through device training, structured education, a 24-hour study support contact, participant diaries, and scheduled remote safety reviews at 48 hours, 2 weeks, 4 weeks, and 8 weeks following randomisation. Device data will be reviewed regularly to assess continuous sensor wear, ketone and glucose levels, and compliance with study procedures. Participants using multiple daily insulin injections will also maintain insulin dose diaries, and all participants will record dietary carbohydrate intake during specified study periods.
To ensure the safety of participants whilst participating in the study, safety monitoring will occur remotely by telephone call by the study doctor or study coordinator. During these follow-ups, study DGK data will be reviewed using the cloud-based platform Libreview to ensure that their glucose and ketone levels are in a safe range, and that the DGK is being worn and functioning correctly. Any adverse events will also be recorded during these sessions. Safety monitoring will occur at 48 hours (Day 2 / Visit 3), two weeks (Week 2 / Visit 4), four weeks (Week 4 / Visit 5) and eight weeks (Week 8 / Visit 6) post-randomisation. More frequent reviews may be conducted if required depending upon the participant’ needs.

Exercise sub-study (optional):
Participation in the exercise sub-study is optional, and not all participants will take part. Only participants who provide separate consent for the sub-study and have been taking dapagliflozin (5 mg/day) for at least 4 weeks will be eligible. These participants will complete four supervised cycling exercise sessions (two morning high-intensity and two evening long-duration sessions) between Weeks 4 and 12. Sessions will be conducted at the study site to evaluate the impact of different DGK ketone alert thresholds (1.0 mmol/L vs 1.5 mmol/L) on post-exercise ketosis and will supervised by an endocrinologist and study nurse.. Blood glucose and ketone levels will be monitored throughout the sessions to ensure participant safety.
During the morning high-intensity session, participants will undergo a total of 40 mins of exercise on a stationary bike, compromised of 20 mins (5x 4 mins) of high-intensity ( approximately 80-90% max heart rate using a heart rate monitor), interspersed with 20 mins (5x 4 mins) of low intensity cycling/ active rest,
During the evening long-duration session, participants will complete a total of 60 mins continuous cycling on a stationary exercise bike at approximately 60% max heart rate. Immediately after, participants will then complete six high-intensity cycling sprints of 30 sec intervals, interspaced with 4 mins recovery (low intensity cycling or rest).
Each session must be scheduled at least 24 hours apart to allow insulin-sensitising effects of antecedent exercise to wash out.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Treatment: Drugs

Description of the comparator or control

The study will compare glycaemic outcomes and ketone metrics between participants responding to ketone thresholds of 1.0 mmol/L versus 1.5 mmol/L and will compare post-intervention glycaemic control with data collected during the pre-treatment run-in period.
Arm 2, wearing a Dual Glucose and Ketone (DGK) sensor with ketone alarms set at 1.5 mmol/L, is considered the comparator group for the purposes of this study.

Control group

Dose comparison

Outcomes

Primary outcome [1]

To determine whether DGK in conjunction with education informing user-responses initiated at ketone levels of 1.0mmol/L is superior to 1.5mmol/L in minimising percent (%) of time spent with ketone levels greater than or equal to 3.0mmol/L in youth with T1D treated with Dapaglifozin.

Timepoint [1]

Commencement to end of study (12 weeks). Frequency: contionous

Primary outcome [2]

To determine whether ketone levels in youth with T1D treated Dapagliflozin 5mg/d and DGK provision in conjunction with education in user-responses can achieve a percent (%) of time with ketones greater than or equal to 3.0mmol/L that does not differ from Run-in period.

Timepoint [2]

At the end of run-in period (Weeks -2 to 0) versus the end of treatment period (Weeks 0 to 12).

Secondary outcome [1]

Percent of time with interstitial ketone levels in different ranges >0.6, >1.0, and >1.5mmol/L over 12 weeks. This will be assessed as a composite outcome.

Timepoint [1]

Commencement to end of study (12 weeks). Frequency: continuous

Secondary outcome [2]

Incidence of diabetic ketoacidosis

Timepoint [2]

Commencement to end of study (12 weeks). Frequency: continuous

Secondary outcome [3]

Change in HbA1c

Timepoint [3]

Week 0 and Week 12 from study commencement

Secondary outcome [4]

Change in CGM metrics. This will be assessed as a composite outcome.

Timepoint [4]

Commencement to end of study (12 weeks). Frequncy: continuous

Secondary outcome [5]

Change in weight

Timepoint [5]

Week 0 and Week 12 from study commencement

Secondary outcome [6]

Change in BMI

Timepoint [6]

Week 0 and Week 12 from study commencement

Secondary outcome [7]

Change in treatment satisfaction using Diabetes Medication System Rating Questionnaire - Short form

Timepoint [7]

Week 0 and Week 12 from study commencement

Secondary outcome [8]

Change in hypoglycaemia awareness, measured using the Gold Score questionnaire, from baseline to follow-up. The Gold Score ranges from 1 to 7, with lower scores indicating better awareness of hypoglycaemia symptoms.

Timepoint [8]

Week 0 and Week 12 from study commencement

Secondary outcome [9]

Change in Pittsburgh Sleep Quality Index

Timepoint [9]

Week 0 and Week 12 from study commencement

Secondary outcome [10]

Change in PROMIS Fatigue - Short form

Timepoint [10]

Week 0 and Week 12 from study commencement

Secondary outcome [11]

Change in health-related quality of life, measured using the EQ-5D-5L instrument. The EQ-5D-5L evaluates health status across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Timepoint [11]

Week 0 and Week 12 from study commencement

Secondary outcome [12]

Change in Problem Areas in Diabetes - Short form

Timepoint [12]

Week 0 and Week 12 from study commencement

Secondary outcome [13]

Change in WHO-5 Well-being index

Timepoint [13]

Week 0 and Week 12 from study commencement

Secondary outcome [14]

Change in Hypoglycaemia Fear Survey - Short Form

Timepoint [14]

Week 0 and Week 12 from study commencement

Secondary outcome [15]

Treatment satisfaction with ketone sensor using Study specific questions regarding treatment satisfaction

Timepoint [15]

Week 12 from study commencement (study end)

Secondary outcome [16]

Ketone sensor usability with System Usability Scale

Timepoint [16]

Week 12 from study commencement (study end)

Secondary outcome [17]

Treatment satisfaction and ketone sensor usability with User Experience Questionnaire. This will be assessed as a composite outcome.

Timepoint [17]

Week 12 from study commencement (study end)

Secondary outcome [18]

Lived experience of a using DGK system during Dapagliflozin treatment

Timepoint [18]

Week 12 from study commencement (study end)

Secondary outcome [19]

Percent time of sensor wear

Timepoint [19]

Commencement to end of study (12 weeks). Frequncy: continuous.

Secondary outcome [20]

Incidence of sensor- related skin infections

Timepoint [20]

Commencement to end of study (12 weeks). Participant self-reported skin infections at the sensor insertion site will be collected at the end of the 12-week study period, covering the entire study duration.

Secondary outcome [21]

Mean duration of ketone sensor survival before replacement (days)

Timepoint [21]

Commencement to end of study (12 weeks). Sensor longevity will be assessed throughout the 12-week study period based on participant-reported sensor replacement dates and device records.

Secondary outcome [22]

Ketone measurement accuracy, assessed by the difference between ketone readings obtained from the dual glucose/ketone sensor (study) and ketone readings obtained from a fingerprick blood ketone test (standard of care).Fingerprick blood ketone testing will not be performed at predetermined intervals. Instead, participants will perform fingerprick blood ketone tests only when clinically indicated according to standard diabetes sick day and ketone management guidelines, or when instructed by the study team. The frequency of testing will therefore vary between participants.

Timepoint [22]

Commencement to end of study (12 weeks). Frequency: continuous

Secondary outcome [23]

Percent of time with interstitial ketone levels in different ranges >1.0,

Timepoint [23]

Commencement to end of study (12 weeks). Frequency: Continuously

Secondary outcome [24]

Percent of time with interstitial ketone levels in different ranges >1.5,

Timepoint [24]

Commencement to end of study (12 weeks). Frequency: Continuously

Eligibility

Key inclusion criteria

• Aged between 13 and 24 years of age inclusive
• Diagnosed with T1D for at least 1 year
• Insulin regimen either on MDI or insulin pump
• Minimum total daily insulin dose 0.4 Units per kg/day (can be on insulin pump or Multiple Daily Injections (MDI))
• HbA1c <9% (86mmol/ mol)
• Minimum daily carbohydrate intake of 100g
• Willing to adhere to the study protocol
• Ability to perform high-intensity exercise (specific to the exercise sub-study)

Minimum age

13 Years

Maximum age

24 Years

Sex

Both males and females

Healthy volunteers

Key exclusion criteria

• Pregnancy or planned pregnancy
• eGFR <30ml/min/1.73m2
• History of DKA in the last 12 months
• Use of low carbohydrate diet (<100g/day)
• Diabetic gastroparesis
• Tape allergy
• Heavy alcohol use (15 standard drinks per week or binge drinking)
• Use of SGLT inhibitor in the last month
• Medications increasing the risk of DKA e.g. steroids, anorectic agents (eg phentermine, naltrexone HCl/bupropion HCl, and GLP 1 RA agonists).
• Major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.
If participants who were deemed eligible to participate at screening and were recruited into the study, lose the capacity to provide ongoing consent they will be withdrawn from the study.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be allocated using a computer-generated random sequence produced by Research Randomizer software. Block randomization in a 1:1 ratio was applied within strata defined by HbA1c (less than 7.5% vs greater than or equal to 7.5%) and age (13-18 vs 19-24 years).

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

Primary (% time with interstitial ketones greater than or equal to 3.0 mmol/L) and secondary outcomes will be compared between groups using ANCOVA, adjusting for baseline values and randomization factors. Subgroup analyses will assess whether treatment effects vary by factors such as age, sex, ketone and glucose levels at baseline, insulin delivery method, C-peptide status, carbohydrate intake, and insulin dose. Exploratory analyses will evaluate age-, sex-, and C-peptide-specific effects. Questionnaire outcomes will also be analyzed using ANCOVA. Alternative statistical methods, including generalized linear models, non-parametric tests, Poisson/negative binomial regression, survival analysis, and linear mixed models, will be used where appropriate based on data characteristics. Exercise sub-study analyses will cover the period from exercise initiation to 12 hours afterward.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/01/2027

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

St Vincent's Hospital (Melbourne) Ltd - Fitzroy

Recruitment postcode(s) [1]

3065 - Fitzroy

Recruitment postcode(s) [2]

3004 - Melbourne

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

3050 - Royal Melbourne Hospital

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Melbourne

Address [1]

Country [1]

Australia

Primary sponsor type

Other Collaborative groups

Name

The Kids Research Institute Australia

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Government body

Name [1]

Child and Adolescent Health Service

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/03/2026

Approval date [1]

19/06/2026

Ethics approval number [1]

RGS0000008479

Summary

Brief summary

Although sodium glucose transporter inhibitors (SGLT2i) are approved in Australia (TGA) for the treatment of children with type 2 diabetes (T2D), their use in people with type 1 diabetes (T1D) is not approved due to the increased incidence of DKA. However, trials have utilised risk-minimising strategies in children and adults to reduce DKA and gain the overall benefits of SGLT2i in diabetes management. This study utilises a Dual Glucose and Ketone (DGK) monitor with a management plan to recognise early ketosis and intervene appropriately. 

This is a 14-week randomised controlled study in children with T1D on SGLTi (dapaglifozin). Two ketone thresholds available in real-time from DGK monitor will be evaluated at 1.0 mmol/L and 1.5 mmol/L with education provided regarding the user intervention. The primary objective is to determine whether DGK in conjunction with user response initiated at 1.0 mmol/L is more effective than 1.5 mmol/L in reducing the time spent with ketone levels greater than or equal to 3.0mmol/L. 

In this randomised parallel-arm study, participants will undergo a 2-week run-in period and will then be randomly assigned 1:1 to two groups. Group 1 will receive education about Algorithm 1 (responses at ketone threshold of 1.0 mmol/L) and Group 2 will receive education about Algorithm 2 (responses at ketone threshold of 1.5 mmol/L).

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Timothy Jones

Address

Perth Children's Hospital, 15 Hospital Avenue, 6009 Nedlands, WA, Perth

Country

Australia

Phone

+61 8 6456 5033

Fax

[email protected]

Contact person for public queries

Name

Timothy Jones

Address

Perth Children's Hospital, 15 Hospital Avenue, 6009 Nedlands, WA, Perth

Country

Australia

Phone

+61 8 6456 5033

Fax

[email protected]

Contact person for scientific queries

Name

Timothy Jones

Address

Perth Children's Hospital, 15 Hospital Avenue, 6009 Nedlands, WA, Perth

Country

Australia

Phone

+61 8 6456 5033

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Only de-identified aggregate data will be published and made available to the public.

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.

Trial Review

Documents added manually

Documents added automatically