Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000614493
Ethics application status
Approved
Date submitted
22/05/2025
Date registered
13/06/2025
Date last updated
13/06/2025
Date data sharing statement initially provided
13/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Artificial Intelligence-guided Cardio-Diabetic Disease Management Program on Follow-up Functional Capacity in People with Diabetes.
Scientific title
Impact of an AI-guided multi-disciplinary disease management program on the aerobic capacity of people with type 2 diabetes.
Secondary ID [1] 314512 0
None
Universal Trial Number (UTN)
Trial acronym
CD-AIM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes mellitus (T2DM) 337590 0
Heart failure (HF) 337595 0
Condition category
Condition code
Cardiovascular 333934 333934 0 0
Other cardiovascular diseases
Metabolic and Endocrine 333999 333999 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The multidisciplinary cardio-protective intervention over 2 years will be characterized by;
1) Baseline assessment of clinical risk using questionnaires, ECG and echo provided by the study nurses, co-ordinators and sonographers
2) Optimizing medical management. This will involve addition of cardioprotective therapy not already in use by these participants - including ACE/ARB, SGLT2 inhibitors and mineralocorticoid antagonists, delivered orally after dispensing in the community. The choice and dosage of agents will be individualized by the medical supervisors of each site in conjunction with the patient's GP, based on participants' responses (eg. blood pressure, renal function). Target doses will be ramipril 10 mg/d, candesartan 32 mg/d, spironolactone 25 mg/d or dapagliflozin 10 mg/d - or dose-equivalents of other compounds in each class. Adherence will be monitored by scripts filled and pill-counts.
3) Exercise intervention. This will involve strength (eg. weights) and aerobic training (eg. stationary bike) for 30 minutes three times each week, of moderate intensity, judged by rating on the Borg RPE scale, based on individual prescription by an accredited exercise physiologist involved with the study. This will be delivered at the study site or remotely, dependent on the circumstances of the participant. Adherence will be documented by the supervising exercise physiologist.
Intervention code [1] 331140 0
Prevention
Comparator / control treatment
Usual care - defined by; 1)the usual prescription of ACE Inhibitors and ARBs, SGLT2 Inhibitors, and Mineralocorticoid Receptor Antagonists (MRAs) by the GP - often primarily influenced by glycemic and blood pressure control, and 2) referral to 5 exercise physiologist sessions/year in accordance with the Medical Benefits Scheme
Control group
Active

Outcomes
Primary outcome [1] 341581 0
Change in functional aerobic capacity
Assessment method [1] 341581 0
Change in peak VO2, assessed using an individualized ramp protocol for the bike - or if not possible, a standard Bruce protocol. The same protocol will be used at baseline and follow-up
Timepoint [1] 341581 0
Baseline and 12 months post randomization
Secondary outcome [1] 447990 0
Preservation of left ventricular (LV) function
Assessment method [1] 447990 0
Change in left ventricular global longitudinal strain (using echocardiography) between baseline and follow-up
Timepoint [1] 447990 0
Baseline and 12 months post randomization
Secondary outcome [2] 448003 0
Preservation of quality of life
Assessment method [2] 448003 0
Change in EQ5D-5L between baseline and follow-up
Timepoint [2] 448003 0
Baseline and 24 months post randomization
Secondary outcome [3] 448002 0
Preservation of everyday function
Assessment method [3] 448002 0
Change in 6-minute walk distance between baseline and follow-up
Timepoint [3] 448002 0
Baseline and 12 months post randomization

Eligibility
Key inclusion criteria
Men and women >65 years with T2DM but no diagnosis of HF, in sinus rhythm
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) HF - documented or undiagnosed (EF 400ng/l). 2) Other cardiac disease (myocardial infarction, angina, >70% coronary stenoses, more than moderate valve disease). 3) already in a supervised exercise program. 4) features incompatible with RCT (unlikely to be adherent with study follow-up; <12 months life expectancy due to concomitant disease; participation in another clinical research trial where blinded treatment would be unacceptable; unable to provide written informed consent); 5) inability to acquire interpretable echo images (uncommon)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization - Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be performed on the basis of intention to treat, irrespective of drop-in of therapy in the controls or drop-outs from medical therapy and training adherence in the DMP.
The primary endpoint (change in aerobic capacity) will be analysed by ANCOVA, to compensate for baseline functional capacity. Secondary endpoints will be assessed by modelling of change (eg in GLS) adjusted for baseline. Endpoint data analyses will also compare change between intervention and usual care subjects using linear and logistic regression to obtain the effect size of the implemented risk factor management program relative to other likely determinants of risk factor modification. Multiple logistic regression will determine independent correlates of HF incidence.
It is difficult to attribute effects to each component in a multifactorial, multidisciplinary intervention. There are many variables driving HF that it is unlikely that one factor will dominate. Some people will be unable to participate in various aspects, and we will use this to examine attributable benefits.
Management of missing data: We will impute missing data using MICE (Multivariate Imputation by Chained Equations).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
30/07/2027
Actual
Date of last data collection
Anticipated
30/07/2029
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 319055 0
Government body
Name [1] 319055 0
NHMRC
Country [1] 319055 0
Australia
Primary sponsor type
University
Name
University of Tasmania
Country
Australia
Secondary sponsor category [1] 321523 0
None
Name [1] 321523 0
Country [1] 321523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317658 0
University of Tasmania Human Research Ethics Committee
Ethics committee address [1] 317658 0
Ethics committee country [1] 317658 0
Australia
Date submitted for ethics approval [1] 317658 0
17/02/2025
Approval date [1] 317658 0
30/04/2025
Ethics approval number [1] 317658 0

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 141726 0
Prof Thomas Marwick
Address 141726 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 141726 0
Australia
Phone 141726 0
+61 427157975
Email 141726 0
tom.marwick@utas.edu.au
Contact person for public queries
Name 141727 0
Thomas Marwick
Address 141727 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 141727 0
Australia
Phone 141727 0
+61 427157975
Email 141727 0
tom.marwick@utas.edu.au
Contact person for scientific queries
Name 141728 0
Thomas Marwick
Address 141728 0
Menzies Institute for Medical Research, 17 Liverpool St, Hobart, Tas 7000
Country 141728 0
Australia
Phone 141728 0
+61 427157975
Email 141728 0
tom.marwick@utas.edu.au

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: tom.marwick@utas.edu.au

Are there extra considerations when requesting access to 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.