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Trial registered on ANZCTR


Registration number
ACTRN12619000840189
Ethics application status
Not required
Date submitted
7/05/2019
Date registered
12/06/2019
Date last updated
12/06/2019
Date data sharing statement initially provided
12/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Living Well With Diabetes: an open-label, single-arm trial of team-based transition to insulin in primary care to improve HbA1c for patients with poorly controlled type 2 diabetes
Scientific title
Living Well With Diabetes: an open-label, single-arm trial of team-based transition to insulin in primary care to improve HbA1c for patients with poorly controlled type 2 diabetes
Secondary ID [1] 298137 0
Nil known
Universal Trial Number (UTN)
U1111-1232-7601
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes (T2D) 312678 0
Condition category
Condition code
Metabolic and Endocrine 311174 311174 0 0
Diabetes
Public Health 311175 311175 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (our “Living Well With Diabetes” program) will be delivered at our 3 Auckland GP clinic practices. Here, we will deliver a service to our patients (Tongan) using an ethnic-specific (Tongan) model of care that provides for a group approach to insulin initiation and intensification. This model 'care plans' our patients towards self-management and, at a collective level, assists family and communities to achieve their goals. Central to our model is the innovative face-to-face group sessions which are geared toward facilitating the delivery of a Self-management Education (SME) approach.

In these group sessions, we will cover evidence around insulin initiation, plus interview our patients to identify barriers to starting treatment and possible solutions. To support this, patients will be provided with printed handouts (designed specifically for this study and translated in Tongan) and will be given hands-on demonstrations with insulin delivery systems and insulin titration tools. To facilitate insulin initiation in these sessions, patients on insulin (patient enablers) will speak to those who need to be on insulin, but not started. These patient enablers are the people with similar demographics and health and socio-economic status as the rest of the non-insulin patients. The non-insulin takers will be able to identify with patient enablers, who will talk about their experience with insulin and how it has impacted their life. These sessions (nurse-led) will be coordinated by our team of diabetes nurses, with assistance from a dietician and a podiatrist; and will comprise 15-20 patients per 3 staff members in each session. The SME sessions will each be 90 minutes in duration. They will run 1-2 monthly over the follow-up period (for 2 years) until patient use of insulin treatment is deemed proficient and adherent by the nurses. Exposure to this intervention will be monitored via attendance logs.
Intervention code [1] 314360 0
Treatment: Other
Intervention code [2] 314499 0
Lifestyle
Intervention code [3] 314500 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319942 0
Change in HbA1c (via serum assay), measured as a continuous variable
Timepoint [1] 319942 0
At 24 months post baseline
Secondary outcome [1] 369953 0
Proportion of participants transferring to insulin (assessed via medical records)
Timepoint [1] 369953 0
At 24 months after baseline
Secondary outcome [2] 369954 0
Proportion of patients who achieved a target HbA1c (normalisation or at least a 40% reduction), assessed via serum assay
Timepoint [2] 369954 0
At 24 months after baseline
Secondary outcome [3] 369955 0
Impact on quality of life assessed with the Assessment of Quality of Life (AQoL-8D) instrument questionnaire
Timepoint [3] 369955 0
At 24 months after baseline
Secondary outcome [4] 369956 0
Impact on depressive symptoms assessed with the Patient Health Questionnaire (PHQ-9)
Timepoint [4] 369956 0
At 24 months after baseline
Secondary outcome [5] 370480 0
Impact on diabetes-specific distress assessed with the Problem Areas in Diabetes (PAID) scale questionnaire
Timepoint [5] 370480 0
At 24 months post baseline
Secondary outcome [6] 370482 0
Healthcare utilisation (consultations with GP/specialists/nurses, hospitalisations, emergency department visits, procedures and imaging/pathology tests) as assessed by medical records
Timepoint [6] 370482 0
At 24 months post baseline

Eligibility
Key inclusion criteria
1. T2D patients who are insulin-naive.
2. At least 2 oral hypoglycaemic agents (OHA) (eg. metformin, sulphonylurea, TZDs, DPP-4 inhibitor) at maximal tolerated doses, or in the opinion of the responsible medical practitioner, insulin is deemed necessary.
3. Doses of the OHAs should be stable for at least 3 months prior to enrollment into the study (or medical practitioner discretion).
4. HbA1c>=7.5% in the last 6 months who are on maximum oral hypoglycaemic agents
5. T2D patients willing to monitor glucose levels at least twice daily
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Type 1 diabetes
2. Previous or current treatment with insulin (excluding the short term (<2 weeks) use of insulin in acute illness or during hospitalization)
3. Significant cognitive impairment
4. Impaired vision or any other physical handicap precluding reliable glucose monitoring administration of insulin
5. Significant renal impairment (eGFR < 20)
6. Any life-threatening illness
7. Pregnancy or planned pregnancy
8. Breastfeeding
9. Major psychiatric disorder
10. Substance misuse (alcoholism, drug addiction, etc)

Study design
Purpose of the study
Educational / counselling / training
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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/05/2019
Date of last participant enrolment
Anticipated
16/08/2019
Actual
Date of last data collection
Anticipated
16/08/2021
Actual
Sample size
Target
254
Accrual to date
3
Final
Recruitment outside Australia
Country [1] 21452 0
New Zealand
State/province [1] 21452 0
Auckland

Funding & Sponsors
Funding source category [1] 302665 0
Government body
Name [1] 302665 0
Ministry of Health
Country [1] 302665 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Tongan Health Society Inc.
Address
1 Fleming St
Onehunga, Auckland 1061
Country
New Zealand
Secondary sponsor category [1] 302594 0
Individual
Name [1] 302594 0
Dr Glenn Doherty
Address [1] 302594 0
Tongan Health Society Inc.
1 Fleming St
Onehunga, Auckland 1061
Country [1] 302594 0
New Zealand

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 303288 0
Ethics committee address [1] 303288 0
Ethics committee country [1] 303288 0
Date submitted for ethics approval [1] 303288 0
Approval date [1] 303288 0
Ethics approval number [1] 303288 0

Summary
Brief summary
Living Well With Diabetes is an open-label, single-arm trial that examines the effectiveness of the “Living Well With Diabetes” program in general practice to help patients with poorly controlled type 2 diabetes for whom insulin is indicated move onto insulin in a timely evidence-based manner.
To facilitate insulin initiation, this program involves:
1) identifying barriers to insulin initiation and possible solutions
2) providing innovative, ethnic-specific and self-management education group sessions which use support from patients on insulin (patient enablers), diabetes nurses, a dietician and a podiatrist
Trial website
Trial related presentations / publications
Public notes
No ethics committee correspondence has occurred. Ethical approval was not required because:
1) our study is a service evaluation of encouraging patient uptake of recommended treatment (using a new approach), that aligns with best treatment practice
2) we are not delivering a package of patient care based on chance (since there is no randomisation of treatment allocation); but, rather, one according to best practice

Contacts
Principal investigator
Name 93142 0
Dr Glenn Doherty
Address 93142 0
Tongan Health Society Inc.
1 Fleming St
Onehunga, Auckland 1061
Country 93142 0
New Zealand
Phone 93142 0
+64 9 6224970
Fax 93142 0
+64 9 6344699
Email 93142 0
[email protected]
Contact person for public queries
Name 93143 0
Glenn Doherty
Address 93143 0
Tongan Health Society Inc.
1 Fleming St
Onehunga, Auckland 1061
Country 93143 0
New Zealand
Phone 93143 0
+64 9 6224970
Fax 93143 0
+64 9 6344699
Email 93143 0
[email protected]
Contact person for scientific queries
Name 93144 0
Glenn Doherty
Address 93144 0
Tongan Health Society Inc.
1 Fleming St
Onehunga, Auckland 1061
Country 93144 0
New Zealand
Phone 93144 0
+64 9 6224970
Fax 93144 0
+64 9 6344699
Email 93144 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
IPD will not be shared as it is not necessary for the analysis/interpretation of the results. However, we will share IPD with the editor/reviewers of the manuscript if requested.


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.