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Trial registered on ANZCTR


Registration number
ACTRN12624000992505
Ethics application status
Approved
Date submitted
30/07/2024
Date registered
14/08/2024
Date last updated
14/08/2024
Date data sharing statement initially provided
14/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor; Exercise Sub-Study
Scientific title
Evaluating Glucose Levels and Risk of Ketoacidosis in People with Type 1 Diabetes Receiving SGLT1/2 inhibitor Therapy Using a Novel Continuous Ketone Sensor (PARTNER); Exercise Sub-Study
Secondary ID [1] 312647 0
None
Universal Trial Number (UTN)
Trial acronym
PARTNER sub-study
Linked study record
This record is a sub-study of ACTRN12624000448549.

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 334610 0
Condition category
Condition code
Metabolic and Endocrine 331196 331196 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
After screening, participants will undergo a 2-week run-in period where they will wear a continuous glucose monitor and ketone sensor and receive education about management of sustained hyperglycemia/ketosis.
After run-in, participants will be randomized to either the intervention or placebo.
The intervention will be Sotagliflozin 200 mg oral tablet daily for three months.
Adherence to intervention will be monitored by counting number of study drugs returned at the end of intervention.
1 exercise session of 40 minutes will be completed after 6-weeks of each arm, a total of two sessions one during the 12-week sotaglioflozin and one during the placebo treatment period.
The sessions will be conducted between 07:00 and 09:30 in the morning proceeding an overnight fast from the previous evening. The exercise session will be high intensity (80-90% of age predicted max heart rate) interval cardio session on a cycle ergometer. The session will entail 4 x 5min 'hard' intervals ensuring the participant is working between the prescribed heart rate limits. The participant will wear a heart rate monitor to ensure appropriate intensity and these sessions will be supervised by post-doctoral research fellows who have experience conducting clinical research exercise sessions.
Wash-out period is 2 weeks between interventions.
Arm 1: Sotagliflozin for 12 weeks, exercise session post week 6 of intervention. Then cross-over to Placebo for 12 weeks after washout
Arm 2: Placebo for 12 weeks, exercise session post week 6 of intervention. Then cross-over to Sotagliflozin for 12 weeks after washout
Session attendance will be recorded in our database and monitored by investigators to ensure adherence to exercise session requirements within the required timeframes.
Intervention code [1] 329164 0
Treatment: Drugs
Intervention code [2] 329165 0
Treatment: Devices
Comparator / control treatment
The control group will be a placebo control group. The placebo tablet will contain the same excipients without the active drug, comprising of croscarmellose sodium, colloidal silicondioxide, microcrystalline cellulose, magnesium stearate, and talc.
Control group
Placebo

Outcomes
Primary outcome [1] 338963 0
The primary outcome will be total % continuous ketone monitor (CKM) time spent >1.5 mmol/L from exercise onset until 24 hours post-exercise for each study arm.
Timepoint [1] 338963 0
Exercise onset (T=0), to 24 hours post exercise (T=24)
Secondary outcome [1] 438036 0
Glycaemic outcome A: Study continuous glucose monitor (CGM) metrics of time in range (% time in range (3.9-10.0mmol/L)) from exercise commencement (t=0) to 2hrs post-exercise (t=2)
Timepoint [1] 438036 0
Beginning exercise (t=0) to 2 hrs post-exercise (t=2)
Secondary outcome [2] 438037 0
Percentage time in range (3.9-10.0 mmol/L) on continuous glucose monitor from exercise commencement (t=0) to 24hrs post exercise (t=24)
Timepoint [2] 438037 0
T=0 to T=24hrs post-exercise
Secondary outcome [3] 438038 0
Mean glucose on continuous glucose monitor.
Timepoint [3] 438038 0
Mean glucose will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise.
Secondary outcome [4] 438039 0
Glucose management indicator on continuous glucose monitor.
Timepoint [4] 438039 0
Glucose management indicator will be monitored in the acute post-exercise period from T= 0 - T=2 hrs post-exercise.
Secondary outcome [5] 438040 0
Glycaemic variability on continuous glucose monitor.
Timepoint [5] 438040 0
Glycaemic variability will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise.
Secondary outcome [6] 438041 0
Percentage time above range (>13.9 mmol/L) on continuous glucose monitor.
Timepoint [6] 438041 0
Percentage time above range will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise.
Secondary outcome [7] 438043 0
Percentage time between range (10.1-13.9 mmol/L) on continuous glucose monitor.
Timepoint [7] 438043 0
Percentage time between range (10.1-13.9 mmol/L) will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise
Secondary outcome [8] 438046 0
Percentage time between range (3.0-3.8 mmol/L) on continuous glucose monitor.
Timepoint [8] 438046 0
Percentage time between (3.0-3.8 mmol/L) range will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise
Secondary outcome [9] 438048 0
Percentage time below range (<3.0 mmol/L) on continuous glucose monitor.
Timepoint [9] 438048 0
Percentage time below range will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise.
Secondary outcome [10] 438050 0
Glycaemic risk index
Timepoint [10] 438050 0
Glycaemic risk index will be monitored in the acute post-exercise period from T=0 - T=2 hrs post-exercise.
Secondary outcome [11] 438051 0
Percentage time ketone levels above 0.6 mmol/L
Timepoint [11] 438051 0
Percentage time ketone levels above (0.6 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=2 hrs post-exercise.
Secondary outcome [12] 438052 0
Percentage time ketone levels above 1.5 mmol/L
Timepoint [12] 438052 0
Percentage time ketone levels above (1.5 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=2 hrs post-exercise.
Secondary outcome [13] 438053 0
Percentage time ketone levels above 3.0 mmol/L
Timepoint [13] 438053 0
Percentage time ketone levels above (3.0 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=2 hrs post-exercise.
Secondary outcome [14] 438054 0
Rating of perceived exertion during exercise
Timepoint [14] 438054 0
Every 10 mins from T=0 - t=40 mins (exercise session completion)
Secondary outcome [15] 438362 0
Mean glucose on continuous glucose monitor.
Timepoint [15] 438362 0
Mean glucose will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise.
Secondary outcome [16] 438363 0
Glucose management indicator on continuous glucose monitor.
Timepoint [16] 438363 0
Glucose management indicator will be monitored in the acute post-exercise period from T=0 - T= 24 hrs post-exercise
Secondary outcome [17] 438364 0
Glycaemic variability on continuous glucose monitor.
Timepoint [17] 438364 0
Glycaemic variability will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise.
Secondary outcome [18] 438365 0
Percentage time above range (>13.9 mmol/L) on continuous glucose monitor.
Timepoint [18] 438365 0
Percentage time above range (>13.9 mmol/L) will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise.
Secondary outcome [19] 438366 0
Percentage time between range (10.1-13.9 mmol/L) on continuous glucose monitor.
Timepoint [19] 438366 0
Percentage time between range (10.1-13.9 mmol/L) will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise
Secondary outcome [20] 438367 0
Percentage time between range (3.0-3.8 mmol/L) on continuous glucose monitor.
Timepoint [20] 438367 0
Percentage time between range ( 3.0-3.8 mmol/L) will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise
Secondary outcome [21] 438368 0
Percentage time below range (<3.0 mmol/L) on continuous glucose monitor.
Timepoint [21] 438368 0
Percentage time below range will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise.
Secondary outcome [22] 438370 0
Glycaemic risk index
Timepoint [22] 438370 0
Glycaemic risk index will be monitored in the acute post-exercise period from T=0 - T=24 hrs post-exercise.
Secondary outcome [23] 438374 0
Percentage time ketone levels above 0.6 mmol/L
Timepoint [23] 438374 0
Percentage time ketone levels above (0.6 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=24 hrs post-exercise.
Secondary outcome [24] 438378 0
Percentage time ketone levels above 1.5 mmol/L
Timepoint [24] 438378 0
Percentage time ketone levels above (1.5 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=24 hrs post-exercise.
Secondary outcome [25] 438379 0
Percentage time ketone levels above 3.0 mmol/L
Timepoint [25] 438379 0
Percentage time ketone levels above (3.0 mmol/L) will be monitored in the acute post-exercise period from T= 0 - T=24 hrs post-exercise.

Eligibility
Key inclusion criteria
Age equal to or greater than 18 years; type 1 diabetes of more than 1 year duration; stable on insulin therapy; HbA1c <10.0%; access to a mobile phone compatible with the ketone monitoring system; willing to adhere to all requirements of the protocol including wearing and responding to information provided by the continuous ketone sensor for the duration of the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy or planned pregnancy; eGFR<30 ml/minute/1.73m2; a history of diabetic ketoacidosis in the last 3 months; diabetic gastroparesis; tape allergy; unable to exercise; use of low carbohydrate diet; heavy alcohol use; major medical or psychiatric illness that in the opinion of the investigator would interfere with protocol adherence or impact participant safety.

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 will be concealed by bottles that are independently labelled at a central administration site
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
3/03/2025
Actual
Date of last data collection
Anticipated
2/09/2025
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26879 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 26880 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [3] 26881 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 42941 0
3065 - Fitzroy
Recruitment postcode(s) [2] 42942 0
3084 - Heidelberg
Recruitment postcode(s) [3] 42943 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 317078 0
Other Collaborative groups
Name [1] 317078 0
The Australian Centre for Accelerating Diabetes Innovations
Country [1] 317078 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 319331 0
None
Name [1] 319331 0
Address [1] 319331 0
Country [1] 319331 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315831 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 315831 0
Ethics committee country [1] 315831 0
Australia
Date submitted for ethics approval [1] 315831 0
20/05/2024
Approval date [1] 315831 0
11/06/2024
Ethics approval number [1] 315831 0

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

Contacts
Principal investigator
Name 135934 0
Prof David O'Neal
Address 135934 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, VIC, 3065
Country 135934 0
Australia
Phone 135934 0
+61 425731665
Fax 135934 0
Email 135934 0
[email protected]
Contact person for public queries
Name 135935 0
Audrey Kong
Address 135935 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, VIC, 3065
Country 135935 0
Australia
Phone 135935 0
+61 433593020
Fax 135935 0
Email 135935 0
[email protected]
Contact person for scientific queries
Name 135936 0
David O'Neal
Address 135936 0
University of Melbourne Dept of Medicine, St Vincent's Hospital Melbourne, 41 Victoria Parade Fitzroy, VIC, 3065
Country 135936 0
Australia
Phone 135936 0
+61 425731665
Fax 135936 0
Email 135936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.