Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000314325
Ethics application status
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Approved
Date submitted
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11/02/2026
Date registered
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12/03/2026
Date last updated
Help: Date last updated
12/03/2026
Date data sharing statement initially provided
Help: Data sharing statement date
12/03/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
Comparing ALternative Models of carE to manage diabetes Distress (CALMED): A type 1 hybrid implementation - effectiveness trial to improve psychological and glycaemic outcomes and avoid hospitalisations in people with type 1 diabetes.
Scientific title
Comparing ALternative Models of carE to manage diabetes Distress (CALMED): A type 1 hybrid implementation - effectiveness trial to improve psychological and glycaemic outcomes and avoid hospitalisations in people with type 1 diabetes.
Additional trial identifiers [1] 314922 0
Nil
Universal Trial Number (UTN)
Trial acronym
CALMED Study
Related trial records

Health condition
Health condition(s) studied:
Diabetes 338252 0
Diabetes distress 338253 0
Mental health 338255 0
Condition category
Condition code
Metabolic and Endocrine 334546 334546 0 0
Diabetes
Mental Health 337041 337041 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants will be randomly allocated to three different models of care for management of diabetes distress:

1. Individual model of care (IMOC): assessment and management of diabetes distress
IMOC delivered by a clinical psychologist is supported by international clinical trial evidence, recommended in guidelines, and is standard care at the 4 hospitals with a DM Service clinical psychologist (Speight, 2026). Patients referred to IMOC will be contacted to organise an initial assessment with the clinical psychologist at each of the 3 sites currently using IMOC. Appointments will be organized in the usual clinical care manner at each site. The clinical psychologist making the initial assessment and management will organise follow-up appointments at a frequency and number determined by their clinical judgement for each individual patient participant (usually 3-4 sessions, but individualised). Appointments are usually up to 60 mins in duration and the treatment methods are individually tailored for each participant. Sessions with the psychologist are focused solely managing diabetes distress; treatment is integrated with DM multi-disciplinary care. It can be delivered either face to face (F2F) or virtually. There are no physical or informational materials provided to all participants assigned to this group. However, some psychologists may provided individual patients with individually tailored informational resources.

2. Group model of care (GMOC): online group assessment and management of diabetes distress
GMOC is a virtual behavioural intervention, based on functional-analytic and behavioural self-management models, delivered in small groups of 3-6 patients. The program is facilitated by a psychologist, who is assisted by a diabetes educator. The program comprises a 6-session multi-component intervention, involving two-hour long group sessions that are held weekly for first 5 weeks followed by a 1-month follow-up, after a 4 week planned ‘self-management’ for maintenance phase. In the program, each patient is provided with a workbook which they will work through individually each session, with the assistance of facilitators.

3. Standard model of care (SMOC): recommendation to participant and their GP to refer participant to a clinical psychologist under a mental health care plan. This is currently standard clinical care in most parts of Australia.


The duration of the allocated intervention will depend on which model of care a participant is randomised to. For the IMOC and SMOC, the duration will be individualised and determined by the treating clinical psychologist. For the GMOC, the intervention will de delivered over 9 weeks.

In the IMOC and GMOC, facilitators will complete a questionnaire for each participant, each session, to assess and monitor program activities and participants' attendance, engagement and progress, where relevant.
Intervention code [1] 331533 0
Treatment: Other
Description of the comparator or control
The standard model of care (SMOC) is the comparator. For this group, the research team will recommend that participants seek referral to a clinical psychologist under a mental health care plan from their General Practitioner. This usual care model operates in hospitals where there is no public clinical psychologist access and in the community. There is no defined duration of the treatment period in the SMOC. It will be determined by the individual psychologist the participant is referred to. This arm of the trial is current usual (standard) care.

The intervention groups, Individual Model of Care (IMOC) and Group Model of Care (GMOC), will be compared to the control treatment (SMOC) on all outcome measures..
Control group
Active

Outcomes
Primary outcome [1] 342212 0
Change in Glycaemic control
Timepoint [1] 342212 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Primary outcome [2] 342213 0
Change in Diabetes distress
Timepoint [2] 342213 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [1] 449994 0
Cost-effectiveness of each model of care.
Timepoint [1] 449994 0
T1 (baseline), T4 (12-month follow-up), T5 (2-year follow-up)
Secondary outcome [2] 449995 0
Change in Anxiety
Timepoint [2] 449995 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [3] 449996 0
Change in Quality of life
Timepoint [3] 449996 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [4] 449997 0
Change in Empowerment in managing one’s diabetes
Timepoint [4] 449997 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [5] 449998 0
Change in Symptoms suggestive of eating disorders
Timepoint [5] 449998 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [6] 449999 0
Change in diabetes self-management behaviour
Timepoint [6] 449999 0
T1 (same time period prior to baseline as for the follow-up time period, if available or 2 weeks at baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [7] 453316 0
Participant satisfaction
Timepoint [7] 453316 0
End of intervention delivery
Secondary outcome [8] 457577 0
Percentage change in the number of diabetes-related emergency department (ED) visits.
Timepoint [8] 457577 0
T1 (same time period prior to baseline as for the follow-up time period), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [9] 457578 0
Percentage change in number of adverse mental health-related ED visits
Timepoint [9] 457578 0
T1 (same time period prior to baseline as for the follow-up time period), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [10] 457579 0
Change in depression
Timepoint [10] 457579 0
T1 (baseline), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [11] 458593 0
Percentage change in the number of diabetes-related hospital admissions.
Timepoint [11] 458593 0
T1 (same time period prior to baseline as for the follow-up time period), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)
Secondary outcome [12] 458596 0
Percentage change in number of adverse mental health-related hospital admissions.
Timepoint [12] 458596 0
T1 (same time period prior to baseline as for the follow-up time period), T2 (4-month follow-up), T3 (8-month follow-up), T4 (12-month follow-up), and T5 (2-year follow up)

Eligibility
Key inclusion criteria
1. Has type 1 diabetes
2. Age: 16 years or older
3. Has moderate to high diabetes distress, defined by score on Type 1 – DDAS questionnaire of 2.5 or higher.
4. Has - poor glycaemic control with HbA1c = 8% or
-recent diabetes related hospital admission and/or
-conflict with the treating MDT or family over DM management.
5. Willingness to provide informed consent and willingness to participate and comply with the study requirements.
6. Received their type 1 diabetes diagnosis at least 12 months prior.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Has a diabetes type other than type 1 diabetes
2. Age <16 years,
3. Has type 1 diabetes diagnosed less than 1 year ago (rationale for this is that people are quite likely to experience diabetes distress at this time due to recency of diagnosis. This may resolve with increased education and competence at self-management)
4. Is pregnant (rationale: additional stressors in pregnancy, glucose targets lower in pregnancy and often women start on insulin pumps/intensive management, which rapidly improves HbA1c)
5. Does not have the cognitive ability to consent to participation
6. Does not have an adequate level of English language skills to be able to participate in the study without use of an interpreter. This will be especially important for participants assigned to the GMOC, which will be conducted only in English.
7. Imminent/high suicide risk (as judged by clinician seeing them, as they need immediate referral to the local acute mental health care team for assessment and management as a priority)
8. Acute psychosis or severe mood disturbance - patients in 6 and 7 will be referred to the acute mental health care team, as per usual practice,
9. Residing in residential care or prison facility (the rationale for this is that they are likely to have more constraints on their ability to attend the intervention appointments, as this is often either beyond their control or less under their control than for people living independently.).
10. Diagnosis of dementia, organic brain syndrome or severe intellectual disability,
11. Alcohol or substance misuse meeting criteria for a disorder within the last 3 months

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)
Randomisation will be computer generated online through REDCap. Block randomisation will occur in blocks of 5-6, depending on the hospital site.
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
Chi-squared or Student t-tests will be used to compare the three MOCs on participant characteristics and baseline values of outcome variables, and to document differences between dropouts and completers using R. Paired t tests will be used separately for each group to determine change in DD and HbA1c from baseline to each follow-up time point.
A linear mixed model will be explored to evaluate the primary outcome of the 3 arms comparative intervention. A random effect will be used to account for the repeated measures of each patient. Similarly in a separate linear mixed model for 2 arm comparative intervention, random effect will be used to account for repeated measures and the different hospitals (cluster effect).

Economic evaluation: A trial-based cost-effectiveness and cost-utility analysis comparing IMOC, GMOC, and SMOC will be conducted from a health system perspective. The costs of IMOC and GMOC will be determined from study records and financial documents. Costs of hospitalisations (admissions, and emergency department presentations) over 3 months will be estimated for patients in each group based on self-reported utilisation and costed at standard national weighted average unit (NWAU) cost weights. The base case analysis will assess the 3-month incremental cost per quality adjusted life year (QALY) gained from each intervention compared with usual care. QALYs will be derived from a standard instrument, the EQ-5D-5L and transformed into utilities using Australian derived tariffs. Secondary analyses will include cost ($) per unit change in HbA1c for IMOC and GMOC in comparison to SMOC at 3 months, and an extension of the cost-utility analysis to 12 months follow-up.

Probabilistic sensitivity analysis will be conducted with non-parametric bootstrapped cost-effect pairs plotted on an incremental cost–effectiveness plane. A cost-effectiveness acceptability curve will be generated for the probability of being cost-effective at different willingness-to-pay thresholds. We will test the robustness of the incremental cost-effectiveness ratios by conducting multiple one-way sensitivity analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2026
Actual
Date of last participant enrolment
Anticipated
16/10/2027
Actual
Date of last data collection
Anticipated
16/04/2030
Actual
Sample size
Target
283
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319484 0
University
Name [1] 319484 0
University of Sydney - Faculty of Medicine and Health
Country [1] 319484 0
Australia
Primary sponsor type
University
Name
University of Sydney - Faculty of Medicine and Health
Address
Country
Australia
Secondary sponsor category [1] 321986 0
None
Name [1] 321986 0
Address [1] 321986 0
Country [1] 321986 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318056 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 318056 0
Ethics committee country [1] 318056 0
Australia
Date submitted for ethics approval [1] 318056 0
01/04/2025
Approval date [1] 318056 0
18/12/2025
Ethics approval number [1] 318056 0

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

Contacts
Principal investigator
Name 142982 0
A/Prof Emily Hibbert
Address 142982 0
The Nepean Clinical School, 62 Derby St, Kingswood NSW 2747
Country 142982 0
Australia
Phone 142982 0
+61247344754
Fax 142982 0
Email 142982 0
[email protected]
Contact person for public queries
Name 142983 0
A/Prof Emily Hibbert
Address 142983 0
The Nepean Clinical School, 62 Derby St, Kingswood NSW 2747
Country 142983 0
Australia
Phone 142983 0
+61247344754
Fax 142983 0
Email 142983 0
[email protected]
Contact person for scientific queries
Name 142984 0
A/Prof Emily Hibbert
Address 142984 0
The Nepean Clinical School, 62 Derby St, Kingswood NSW 2747
Country 142984 0
Australia
Phone 142984 0
+61247344754
Fax 142984 0
Email 142984 0
[email protected]

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?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 15 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Contact Principal Investigator Emily Hibbert via email - [email protected]

Are there extra considerations when requesting access to individual participant data?
Yes: Institutional policies on data sharing.



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.