Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000302651
Ethics application status
Approved
Date submitted
27/02/2014
Date registered
21/03/2014
Date last updated
17/09/2021
Date data sharing statement initially provided
17/09/2021
Date results provided
17/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Improving the transition of care for people with diabetes
Scientific title
Comparing people with type 2 diabetes who initiate insulin in the community to standard care (people initiating insulin in hospital) in hospital length of stay, HbA1c and Diabetes Treatment Satisfaction.
Secondary ID [1] 284163 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 291261 0
Condition category
Condition code
Metabolic and Endocrine 291606 291606 0 0
Diabetes
Public Health 291783 291783 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Transition Diabetes Team consisting of a community based credentialed diabetes educator working with a hospital based endocrinologist, to support the person with type 2 diabetes initiating insulin to self manage insulin therapy in their home.

Duration of visit likely 1.5 hours for the first visit, with subsequent contact being either home visits or phone contact, with the duration of contact dictated by the needs of the participant. Part of this project is to collect information regarding the number and duration of contact required to have people with type 2 diabetes initiate insulin.

The home visits will include discussion of:
1. Diabetes - physiology, signs and symptoms, reason/methods for management
2. Insulin - doses, administration, action, injection technique etc..
3. Self Blood Glucose Management - Meter/supplies, technique, testing times/frequency/records, factors affecting tests.
4. Hypoglycemia - causes, signs and symptoms, treatment and prevention, glucagon administration.
5. Exercise - rationale/effect on blood glucose levels, pracautions, exercise plan.
6. Nutrition - general guidelines and referral to dietitian.
7. National Diabetes Services Scheme.
8. Driving
Written information will also be provided on the above.

Once credentialed diabetes educator confident that the participant is able to self-manage insulin, they will refer the participant to local community diabetes services and cease follow up - this can be up to 4 months post discharge. Part of the project aims is to evaluate how long it takes for people starting insulin to be able to self manage. Each participant will be given a follow up appointment with the Austin Health Endocrinologist at 4 months post discharge.
Intervention code [1] 288865 0
Other interventions
Comparator / control treatment
Current care: hospital based diabetes educators to support the person with type 2 diabetes initiating insulin to self manage insulin therapy while in hospital.
Control group
Active

Outcomes
Primary outcome [1] 291549 0
Length of hospital stay
Timepoint [1] 291549 0
Data will be collected in the intervention group at 2-4 weeks discharge from hospital on hypo/hyperglycaemic events (this information will be readily available from the control group in the participant medical records).

Final data collection will occur at 4 months post discharge from hospital for all groups.
Secondary outcome [1] 307050 0
Average blood glucose levels using HbA1c.
Timepoint [1] 307050 0
At 4 months post discharge from hospital.
Secondary outcome [2] 307051 0
Diabetes Treatment Satisfaction using the Diabetes Treatment Satisfaction Questionnaire.
Timepoint [2] 307051 0
At 4 months post discharge from hospital.
Secondary outcome [3] 307052 0
Review of hospital electronic records for hospital readmission rates.
Timepoint [3] 307052 0
At 4 months post discharge from hospital

Eligibility
Key inclusion criteria
a. Adults greater than 18 years of age
b. Type 2 diabetes patients needing insulin post discharge
c. Admitted into Austin Health
d. Diabetes management can be improved by adding or changing insulin or other injectable therapy to management.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those who do not fit the inclusion criteria, and patients who are unable to give informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This study is being undertaken with people who are admitted into Austin Health with the stipulated inclusion criteria. All patients with diabetes will be screened by the endocrinology registrar for their eligibility to participate in the trial and if fulfilling the criteria, will be asked to participate.

After consent, baseline data will be collected after which participants will be randomly allocated into the intervention or control group.

Group allocations will be concealed by writing allocations on a card, and placing in a sealed envelope, with each consecutive participant being given their allocation by the Diabetes Registrar, once consent has been obtained.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using block randomization, generated from a random number table using Excel, with consecutive recruited participants allocated the next number in the list. Equal numbers of Standard Care and Diabetes Transition Group participants will be assigned to each group.
Group allocations will be concealed by writing allocations on a card, and placing in a sealed envelope, with each consecutive participant being given their allocation by the Diabetes Registrar, once consent has been obtained.
Due to the obvious difference in treatment protocols, the study will be unblinded to the participants and the investigators.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All statistical analyses will be based on the intent-to-treat population.

Data will be analysed using descriptive statistics and interpreted in an explorative manner. Plausibility checks will be performed for demographic data, HbA1c and other medical values. Absolute and relative frequencies will be calculated for qualitative variables, and adjusted relative frequencies will be calculated for variables with missing data points.

Demographic, medical history, and baseline data will be summarised by treatment group and analysed for comparability across groups using a Wilcoxon rank sum test for pairwise comparisons. A p-value of 0.05 or less will be considered statistically significant.

For Diabetes Treatment Satisfaction Questionnaire, repeated-measures analysis of variance will be used, and treatment comparisons will be performed using Wilcoxon rank sum tests on change from baseline values.

Quantitative data analysis will be performed using SPSS, (version 21, IBM Armonk, New York, USA).

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/03/2014
Actual
28/04/2014
Date of last participant enrolment
Anticipated
Actual
30/11/2015
Date of last data collection
Anticipated
Actual
31/03/2016
Sample size
Target
250
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2147 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment postcode(s) [1] 7826 0
3081 - Heidelberg West

Funding & Sponsors
Funding source category [1] 288795 0
Charities/Societies/Foundations
Name [1] 288795 0
Lord Mayors Charitable Foundation
Country [1] 288795 0
Australia
Funding source category [2] 288796 0
Charities/Societies/Foundations
Name [2] 288796 0
The Estate of the Late GWA Griffiths
Country [2] 288796 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
RDNS, Royal District Nursing Service
Address
31 Alma Road
St Kilda
Victoria, 3182
Country
Australia
Secondary sponsor category [1] 287491 0
Hospital
Name [1] 287491 0
Austin Health
Address [1] 287491 0
Endocrine Department
Level 2 Centaur Building Repatriation Campus
Heidelberg West
Victoria, 3081
Country [1] 287491 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290638 0
RDNS
Ethics committee address [1] 290638 0
Ethics committee country [1] 290638 0
Australia
Date submitted for ethics approval [1] 290638 0
Approval date [1] 290638 0
24/02/2014
Ethics approval number [1] 290638 0
Ethics committee name [2] 290639 0
Austin Health
Ethics committee address [2] 290639 0
Ethics committee country [2] 290639 0
Australia
Date submitted for ethics approval [2] 290639 0
06/02/2014
Approval date [2] 290639 0
Ethics approval number [2] 290639 0

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

Contacts
Principal investigator
Name 46546 0
Dr Rajna Ogrin
Address 46546 0
Bolton Clarke
Suite 1.01
973 Nepean Highway, Bentleigh, 3204 Victoria
Country 46546 0
Australia
Phone 46546 0
613 9536 5245
Fax 46546 0
Email 46546 0
rogrin@boltonclarke.com.au
Contact person for public queries
Name 46547 0
Rajna Ogrin
Address 46547 0
Bolton Clarke
Suite 1.01
973 Nepean Highway, Bentleigh, 3204 Victoria
Country 46547 0
Australia
Phone 46547 0
613 9536 5245
Fax 46547 0
Email 46547 0
rogrin@boltonclarke.com.au
Contact person for scientific queries
Name 46548 0
Rajna Ogrin
Address 46548 0
Bolton Clarke
Suite 1.01
973 Nepean Highway, Bentleigh, 3204 Victoria
Country 46548 0
Australia
Phone 46548 0
613 9536 5245
Fax 46548 0
Email 46548 0
rogrin@boltonclarke.com.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.