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Trial registered on ANZCTR


Registration number
ACTRN12616001160426
Ethics application status
Approved
Date submitted
6/08/2016
Date registered
25/08/2016
Date last updated
24/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Paying Adolescents to Improve type 1 Diabetes by testing Blood Glucose (PAID4BG)
Scientific title
Payment rewards for blood glucose testing to improve type 1 diabetes management in adolescents
Secondary ID [1] 289867 0
None
Universal Trial Number (UTN)
U1111-1186-0826
Trial acronym
PAID4BG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 299814 0
Condition category
Condition code
Metabolic and Endocrine 299740 299740 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Reward schedule for those randomised to the reward group (2/3 chance, target 20 participants):
90-day monetary reward according to the following schedule: $0.20 per test up to a maximum of 8 tests per day, plus $0.20 bonus for 4 tests per day, and $0.20 bonus for obtaining at least 2 glucose test results between 4.5-8mmol/L per day. Maximum $2 per day, so maximum $180 over 90 days study intervention duration or minimum $20 over 90 days will be provided upon final 12 week meter review and HbA1c result. Monetary rewards will only be provided every 4 weeks for the first 90 days, upon presentation of BG meter for checking or upon email receipt of the direct electronic meter download results. Additional $20 will provided after 1 year when HbA1c is done and BG meter is presented for review or download at this time point.
Intervention code [1] 295553 0
Behaviour
Comparator / control treatment
Reward schedule for those in the usual care group (1/3 chance, target 10 participants):
A much smaller $20 reward will be provided at 12 weeks and 1 year time points upon meter review/download and HbA1c result to ensure these tests are done and control participants don't drop out disproportionately.
Control group
Active

Outcomes
Primary outcome [1] 299198 0
Mean daily Self Monitoring of Blood Glucose (SMBG) frequency (assessed by meter download for the past 1 month)
Timepoint [1] 299198 0
12 weeks
Primary outcome [2] 299293 0
HbA1c (laboratory test)
Timepoint [2] 299293 0
12 weeks
Secondary outcome [1] 326483 0
Composite outcome of Change in diabetes self management efficacy and satisfaction by Problem Areas in Diabetes (PAID) and SF-12 questionnaires
Timepoint [1] 326483 0
12 weeks and 1 year
Secondary outcome [2] 326484 0
Non-Attendance in scheduled clinic appointments
Timepoint [2] 326484 0
at 1 year
Secondary outcome [3] 326485 0
Number of severe hypoglycaemia episodes (requiring assistance to recognise and/or treat) as reported by the patient and any clinical records
Timepoint [3] 326485 0
at 1 year
Secondary outcome [4] 326486 0
Number of hospital admissions according to clinical records (electronic health information available in clinic)
Timepoint [4] 326486 0
over 1 year period

Eligibility
Key inclusion criteria
Inclusion criteria
*Type 1 diabetes – at least 12 months duration
*HbA1c > 75 mmol/mol in at least 2 consecutive tests
*Age 16-25 years
*Access to a computer to upload glucose meters and transmit proof of testing by email, or willing to come to clinic to provide this
*living in Counties Manukau Health area
*Mobile phone ownership to receive and send texts
*Able to perform SMBG and adjust own insulin
*SMBG frequency 2 or less per day (average over past 1 month)
Minimum age
16 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Any medical condition or medications known to alter glycemic control
*Plans to change insulin delivery mode
*Using continuous glucose sensor
*Neurocognitive impairment or significant psychiatric issues

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised random 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
This is a pilot two arm RCT in which we plan to recruit 20 subjects in the intervention arm and 10 patients in the control arm. The pooled standard deviation (SD) of HbA1c in the Petry study was 13mmol/mol. Using this relatively large SD, indicates that a sample size of 20 intervention vs 10 control will give us 80% power to detect a difference in HbA1c of 14.8 mmol/mol between the two groups. using alpha of 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/09/2016
Actual
4/11/2016
Date of last participant enrolment
Anticipated
2/06/2017
Actual
Date of last data collection
Anticipated
2/06/2018
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 8080 0
New Zealand
State/province [1] 8080 0

Funding & Sponsors
Funding source category [1] 294243 0
Charities/Societies/Foundations
Name [1] 294243 0
Graeme Mack Diabetes Research Grant, Diabetes NZ Auckland Branch
Country [1] 294243 0
New Zealand
Primary sponsor type
Individual
Name
Rinki Murphy
Address
Department of Medicine
FMHS
University of Auckland
Private bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 293078 0
None
Name [1] 293078 0
None
Address [1] 293078 0
None
Country [1] 293078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295667 0
Health and Disability Ethics Committee
Ethics committee address [1] 295667 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 295667 0
New Zealand
Date submitted for ethics approval [1] 295667 0
05/08/2016
Approval date [1] 295667 0
02/09/2016
Ethics approval number [1] 295667 0

Summary
Brief summary
OBJECTIVES: To assess the impact of a 12 week financial reward programme to increase self monitoring of blood glucose (SMBG) and improve diabetes control in adolescents with poorly controlled type 1 diabetes

METHODS: Two-arm, randomized, controlled trial of 30 adolescents. Key eligibility criteria will be type 1 diabetes, age 16-25 years, HbA1c > 75mmol/mol, living in Counties Manukau Health area, and history of SMBG frequency of 2 or less per day. Consenting participants will be randomized 2:1 to either intervention of monetary reward dependent on monthly evidence of daily SMBG (maximum of $2 per day, $180 over 90 days of study + $20 at 12 months) or control (standard care but small financial rewards of $20 at 90 days and $20 at 12 months, for HbA1c assessment and providing BG upload at these two timepoints). Primary outcomes will be mean daily SMBG frequency and HbA1c at 12 weeks and at 1 year. Assuming a standard deviation of 13mmol/mol in HbA1c, a sample size of 20 intervention vs 10 control will provide 80% power to detect a difference of 14.8mmol/mol HbA1c between the two groups.

EXPECTED OUTCOMES: This novel study design explores a potentially cost-effective intervention designed to improve health care behavior of adolescents with type 1 diabetes in effort to improve their glycemic control and reduce risk of subsequent hospitalization and diabetes complications. Given the acceptability and increased effect of financial rewards to promote health behavior, which have been seen in recipients from greater social deprivation scores in other disorders, this type of intervention has the potential to reduce health inequalities, and could be adopted in other centres.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68074 0
Dr Rinki Murphy
Address 68074 0
Department of Medicine
FMHS, University of Auckland
Private Bag 92019
Auckland 1142
Country 68074 0
New Zealand
Phone 68074 0
+6499236313
Fax 68074 0
Email 68074 0
[email protected]
Contact person for public queries
Name 68075 0
Joyce Roberts
Address 68075 0
Whitiora Diabetes Centre
100 Hospital Road
Otahuhu
Auckland 2025
Country 68075 0
New Zealand
Phone 68075 0
+64(0)21074061
Fax 68075 0
Email 68075 0
[email protected]
Contact person for scientific queries
Name 68076 0
Rinki Murphy
Address 68076 0
Department of Medicine
FMHS, University of Auckland
Private Bag 92019
Auckland 1142
Country 68076 0
New Zealand
Phone 68076 0
+6499236313
Fax 68076 0
Email 68076 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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