Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001508763p
Ethics application status
Submitted, not yet approved
Date submitted
3/11/2022
Date registered
5/12/2022
Date last updated
14/01/2024
Date data sharing statement initially provided
5/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and generalisability of a diabetes management program in rural NSW to optimise glucose control for young people (aged 0-18yo) with type 1 diabetes
Scientific title
Feasibility and generalisability of a diabetes management program in rural NSW to optimise glucose control for young people (aged 0-18yo) with type 1 diabetes
Secondary ID [1] 308335 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 328126 0
Condition category
Condition code
Metabolic and Endocrine 325179 325179 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Success with Intensive Insulin Managment (SWIIM) program is a management program for young people with type 1 diabetes (T1D) developed at the John Hunter Children's Hospital (JHCH) over the last 18 years. It comprises management of type 1 diabetes from diagnosis to transition to adult services and is delivered by a multidisciplinary team. Aspects of the program include:

1. Inpatient education program for newly diagnosed type 1 diabetes
The aim of the initial admission is to manage diabetic ketoacidosis, commence subcutanoeus insulin and provide education to patients and family members.
Individual inpatient education is delivered by diabetes educators and dietitians. This includes 180 minutes of diabetes education, 180 minutes of dietary education and social work support is provided as required by the families.

2. School education
Schools, preschools and daycare centres receive a 3 hour education session delivered by a diabetes educator on insulin administration, management of hypo/hyperglycaemia and activity. An individualised school plan is provided for each patient. Schools may contact diabetes educators by phone during business hours. If there is a change in therapy or the child attends a new school, the school visit is repeated.

3. EzyBICC insulin adjustment
EzyBICC cards are individualised dosing cards that calculate the meal insulin dose based on an insulin to carbohydrate ratio and correction factor. This allows flexibility for the amounts of carbohydrate eaten and provides correction for hyperglycaemia. Doses are adjusted by the clinician throughout the inpatient admission and at outpatient reviews. Families are encouraged to change to a different card if the postmeal blood glucose is not in target.

4. Insulin pump therapy
Insulin pump settings are individualised in accordance with the manufacturer’s recommendations. Doses are adjusted by the clinician throughout the inpatient admission and at outpatient reviews. Families are encouraged to change to adjust the setting if the blood glucose is not in target.

5. Written resources
The following written resources were developed by the JHCH team and are provided to families prior to discharge after initial diagnosis:
- 10 Essential Habits for diabetes management
- How to use ezy-BICC cards
- Hypo treatment (pictorial education)
- How to communicate with school
- How to access NDSS supplies
- Identification of carbohydrate, protein and fat
- School and lunchbox ideas
- How to read food labels

6. Outpatient reviews
Families can contact diabetes educators by phone/email during business hours and are encouraged to maintain phone contact daily for the first 1-2 weeks after discharge to allow ongoing dose adjustment and to address queries and concerns.
Patients are reviewed face-to-face in outpatient clinic 2-6 weeks after discharge by diabetes nurse educator and dietitian for a 60 minute review. 30 minute face-to-face reviews with the paediatrician occur on a 3 monthly basis following discharge. During these visits height, weight and HbA1c are measured. Continuous glucose monitor downloads, blood glucose records and insulin pump downloads are reviewed and insulin doses are adjusted. Families are given the opportunity to discuss issues and concerns. Education is provided as needed. Families are seen by diabetes nurse educator, dietitian and social worker for a face-to-face 30 minute review once per year but can be reviewed more frequently if there is a clinical need.

The SWIIM program will be implemented in two centres in the Mid-North Coast Local Health District (MNCLHD) in rural NSW over a 2 year period. The program will be implemented with the following steps:
1. 5 day outreach visit (3 days Coffs Harbour, 2 days Port Macquarie) from paediatric endocrinologist where the program will be introduced to local clinicians and patients/their families.
2. Delivery of written resources described the program to clinicians and the above written resources for families will be delivered at the beginning of the implementation.
3. Mentoring sessions for MNCLHD healthcare providers with JHCH healthcare providers (physicians, diabetes educators and dietitians) - 3 hour sessions twice per year.
4. Six monthly 5 day site visits from the paediatric endocrinologist where an outpatient review will be conducted for each patient.
5. Twice yearly collaborative review meetings with JHCH and MNCLHD teams to assess progress of the implementation, refine implementation strategies and monitor data collection.
Intervention code [1] 324786 0
Treatment: Other
Intervention code [2] 324942 0
Behaviour
Intervention code [3] 324943 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333006 0
Average clinic HbA1c assessed using blood samples
Timepoint [1] 333006 0
Baseline, 6 months, 12 months, 18 months, 24 months post program implementation
Secondary outcome [1] 415524 0
Patient satisfaction with diabetes management as measured by the Diabetes Treatment Satisfaction Questionnaire
Timepoint [1] 415524 0
Baseline, 12 months and 24 months post program implementation.
Secondary outcome [2] 415525 0
Feasibility of the program as demonstrated by clinician satisfaction with diabetes management using questionnaire designed for this study.
Timepoint [2] 415525 0
Baseline, 12 months, 24 months post program implementation.
Secondary outcome [3] 415526 0
Rate of acute diabetes related complications leading to hospitalisation as assessed by local hospital medical records.
Timepoint [3] 415526 0
Baseline, 6 months, 12 months, 18 months, 24 months post program implementation.

Eligibility
Key inclusion criteria
Diagnosis of type 1 diabetes and attending diabetes clinic in the Mid-North Coast Local Health District
Clinicians working in the type 1 diabetes clinic at Port Macquarie Hospital and Coffs Harbour Health Campus.
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil

Study design
Purpose of the study
Treatment
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23495 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [2] 23496 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [3] 26022 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 38902 0
2444 - Port Macquarie
Recruitment postcode(s) [2] 38901 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 41868 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 312580 0
Self funded/Unfunded
Name [1] 312580 0
Not funded
Country [1] 312580 0
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan, NSW 2308
Country
Australia
Secondary sponsor category [1] 314189 0
None
Name [1] 314189 0
Address [1] 314189 0
Country [1] 314189 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311906 0
Hunter New England Human Research Ethics Commitee
Ethics committee address [1] 311906 0
John Hunter Hospital
Lookout Road
New Lambton Heights, NSW 2305
Ethics committee country [1] 311906 0
Australia
Date submitted for ethics approval [1] 311906 0
02/11/2022
Approval date [1] 311906 0
Ethics approval number [1] 311906 0

Summary
Brief summary
Type 1 diabetes (T1D) requires intensive insulin management to maintain blood glucose levels in the normal range. Access to specialist care is vital for optimal management. Without optimal management, serious complications develop including blindness, kidney failure, heart attack, strokes, nerve damage and early death. HbA1c is a blood test that reflects blood glucose levels over a 3 month period and is a good indicator of risk of diabetes related complications.

Many young people with T1D in rural New South Wales have limited access to specialist care. The John Hunter Children's Hospital (JHCH) in Newcastle, NSW have developed a diabetes management program (Success with Intensive Insulin Management (SWIIM)) and achieve among the best diabetes related outcomes in Australia.

In this research we will implement the SWIIM program in two centres in rural New South Wales and assess its impact on diabetes related outcomes and treatment satisfaction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122794 0
Prof Bruce King
Address 122794 0
John Hunter Children's Hospital
Lookout Road
New Lambton Heights 2305
NSW
Country 122794 0
Australia
Phone 122794 0
+61407838422
Fax 122794 0
Email 122794 0
Bruce.King@health.nsw.gov.au
Contact person for public queries
Name 122795 0
Prof Bruce King
Address 122795 0
John Hunter Children's Hospital
Lookout Road
New Lambton Heights 2305
NSW
Country 122795 0
Australia
Phone 122795 0
+61407838422
Fax 122795 0
Email 122795 0
Bruce.King@health.nsw.gov.au
Contact person for scientific queries
Name 122796 0
Prof Bruce King
Address 122796 0
John Hunter Children's Hospital
Lookout Road
New Lambton Heights 2305
NSW
Country 122796 0
Australia
Phone 122796 0
+61407838422
Fax 122796 0
Email 122796 0
Bruce.King@health.nsw.gov.au

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.