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Trial registered on ANZCTR


Registration number
ACTRN12620001017910
Ethics application status
Approved
Date submitted
10/08/2020
Date registered
7/10/2020
Date last updated
14/07/2023
Date data sharing statement initially provided
7/10/2020
Date results information initially provided
14/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising self-management in youth with type 1 diabetes to improve short-term glycaemic control: OPTIMISE Study
Scientific title
Developing a multicomponent intervention targeting short-term glycaemic control in youth with type 1 diabetes: An optimisation trial of glucose monitoring, sleep hygiene, snacking education and values-guided self-management interventions
Secondary ID [1] 301990 0
Lottery Health Research grant LHR-2020-128791
Universal Trial Number (UTN)
Universal Trial Number (UTN): U1111-1256-1248
Trial acronym
OPTIMISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 318555 0
Condition category
Condition code
Metabolic and Endocrine 316565 316565 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomised to one of 16 experimental groups comprised of a 4-week 'no intervention' phase or up to four 4-week interventions that are delivered during the same 4-week intervention phase (i.e., a participant randomised 'Yes' to all candidate components will receive all four interventions within a single 4-week intervention phase). Delivery will be 1-to-1. Adherence to the intervention will be assessed via self-report on the study exit evaluation questionnaire.

Continuous glucose monitoring (CGM): A Dexcom G6 transmitter and 4 Dexcom G6 sensors will be provided at the baseline study visit (intervention education duration - approximately 30 minutes). Participants will wear the interstitial glucose sensors per manufacturer's guidelines (on their abdomen, buttocks, upper arm). The sensor does not require calibration. Sensors are changed every 10 days. A trained research nurse will provide education on using the G6 for glucose monitoring based on the manufacturer's guidelines, supervise the first sensor being applied by the participant, and sync the glucose readings to the Dexcom G6 app on a personal smartphone. All CGM systems will be synced to Dexcom Clarity, a password-protected website for accessing CGM data. Participants' glucose patterns will be reviewed at the 14-day follow-up visit (intervention education duration - approximately 15 minutes). If time in range (sensor glucose values 3.9-10.0 mmol/L) is <70% then the CGM system low and high alert settings may be adjusted to encourage action to treat out-of-range levels. Participants in this study group will be required to wear both a Dexcom G6 sensor and a FreeStyle Libre Pro sensor during the final 2 weeks of the intervention phase.

Sleep extension: All participants will receive sleep hygiene education from a trained research nurse at the baseline visit (education duration - approximately 15 minutes). The sleep hygiene educational materials were developed for New Zealand adolescents in an unrelated study and are being used with permission. At the baseline visit (intervention duration - approximately 5 minutes), those who are allocated 'Yes' to sleep extension will be asked to go to bed one hour earlier than their usual bedtime on weekdays and weekends (as determined by their baseline median “lights out” time on weekdays and weekends collected via self-report) each night for the remaining trial duration while maintaining their usual wake up time. A follow-up will be conducted at the 14-day visit to assess progress towards achieving an extra hour of sleep each night and revising sleep extension to 45 minutes or 30 minutes if having difficulty achieving a full hour of sleep extension (intervention duration approximately 15 minutes). Participants will not be provided with a device that provides them with feedback on their sleep activity.

Snacking education and goalsetting: At the baseline visit (intervention duration - approximately 15 minutes), a trained research nurse will provide practical snacking education, including a handout of healthy snack options and the importance of timing and frequency of snacks to avoid grazing. Educational materials provided have been adapted for the New Zealand context from "Snacking 101: An explainer for people living with T1D"(https://jdrf.org.au/snacking-101-an-explainer-for-people-living-with-t1d/) with permission. Participants will select a snacking-specific behaviour to change and set a goal to achieve the change during the 4-week intervention phase. A follow-up will be conducted at the 14-day visit to assess progress towards completing the goal and revising the goal as needed (intervention duration approximately 15 minutes). Participants will not be provided with a food diary to track their progress towards their goal.

Values-guided self-management: a research fellow trained in Acceptance and Commitment Therapy will meet with participants allocated 'Yes' to this candidate component for a single 30-60 minute session in person or via freely available teleconference software (Zoom) within one week of the baseline visit. The session will focus on identifying what matters to the participant (their values), how diabetes has been an obstacle to valued-living, and setting a goal to change one diabetes-specific behaviour that cultivates valued-living. Barriers to achieving the goal will be explored, with mindfulness and acceptance strategies taught to overcome challenges as relevant. A follow-up will be conducted at the 14-day visit to assess progress towards completing the goal and revising the goal as needed (intervention duration approximately 15 minutes).
Intervention code [1] 318279 0
Lifestyle
Intervention code [2] 318280 0
Behaviour
Comparator / control treatment
For each candidate intervention component, participants allocated 'Yes' will be compared to those allocated 'No'. The total duration

5 participants will be allocated 'No' to all four candidate components; however, these participants are not considered a control group. Their data will be combined with all other participants allocated 'No' for each intervention.

All participants will continue routine diabetes care, which includes a diabetes clinic visit with a multidisciplinary team approximately every 3 months. Participants allocated 'No' to Dexcom G6 CGM will continue their usual glucose monitoring approach (e.g. finger-prick blood tests with their usual glucose meter). Participants who need medical advice in response to changes in their glucose levels as the result of study participation will be referred to their usual diabetes care provider.
Control group
Active

Outcomes
Primary outcome [1] 324696 0
Change in percentage of time in range (3.9-10.0 mmol/mol) as measured by an interstitial continuous glucose monitoring sensor in the 14 days prior to the baseline and final study visits.
Timepoint [1] 324696 0
Baseline, 14-days, 28-days post-commencement of intervention.
Secondary outcome [1] 385415 0
Self-reported acceptability of candidate components assessed with a non-validated questionnaire specifically developed for this study.
Timepoint [1] 385415 0
28 days post-commencement of intervention
Secondary outcome [2] 385417 0
Self-reported adherence to diabetes self-care recommendations as measured by the validated Self-Care inventory-Revised.
Timepoint [2] 385417 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [3] 385418 0
Self-reported sleep-related impairment as measured by the validated Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment questionnaire
Timepoint [3] 385418 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [4] 385419 0
Self-reported sleep disturbance as measured by the validated PROMIS Sleep Disturbance questionnaire
Timepoint [4] 385419 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [5] 385420 0
Self-reported sleep-facilitating and sleep-inhibition practices as measured by the validated Adolescent Sleep Hygiene Scale.
Timepoint [5] 385420 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [6] 385421 0
Snacking habits (timing, frequency and snack food type) as measured by an invalidated questionnaire developed by the research team with input from three registered dietitians and a biostatistician.
Timepoint [6] 385421 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [7] 385422 0
Self-reported acceptance of diabetes as measured by the validated Diabetes Acceptance and Action Scale-Revised.
Timepoint [7] 385422 0
Baseline, 14-days, and 28-days post-commencement of intervention
Secondary outcome [8] 385423 0
Self-reported valued-living as measured by the validated Valuing Questionnaire.
Timepoint [8] 385423 0
Baseline, 14-days, and 28-days post-commencement of intervention

Eligibility
Key inclusion criteria
This study will enrol youth:

• with a type 1 diabetes diagnosis of at least 12 months
• have a mean HbA1c of at least 58 mmol/mol (above clinical recommendations for HbA1c) in the 6 months prior to enrolment
• self-report time in bed (time between lights out and waking in the morning) of no more than 10 hours a night (ensuring any sleep extension does not place them in the “not recommended” category for sleep duration (greater than 11 hrs);
• be willing to wear an ActiGraph (a wrist-worn device for measuring activity, similar to a FitBit) continuously for 7 days and 8 nights during the first and final weeks of the study period;
• be willing to discuss barriers to self-management with a member of research staff who is not involved with their diabetes care; and
• be willing to wear an interstitial glucose sensor for 6 weeks.
Minimum age
13 Years
Maximum age
20 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• significant comorbidities that would interfere with study participation (e.g., uncontrolled diabetes complications, uncontrolled psychiatric conditions [PHQ-9 score is greater than or equal to 20 (severely depressed)], diagnosed sleep disorders, diagnosed and currently active eating disorder);
• current user of continuous glucose monitoring technology (other than intermittent hospital/ clinical use in the previous 3 months; current FreeStyle Libre ‘flash’ glucose monitoring use is not an exclusion criterion);
• chronic use of sleep medication; or
• shift worker (works or has plans to work at least 3 hours between midnight and 5am

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)
A biostatistician will randomly allocate participants to one of 16 experimental conditions. Each experimental condition represents a different treatment protocol. Group allocation will be revealed after all baseline questionnaires are complete.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated list of random numbers
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a correlation between measures of 0.6 and a standard deviation of 10 (from unpublished data) a sample size of n=80 is required. This sample size (n=5 in each of the 16 groups and n=40 assigned to each component) gives 80% power at a=0.05 level to detect an improvement of 5% in time in range. Using effect coding, the interaction terms (which assess combinations of intervention components) are equally powered to the main effects.

It is important to note that the factorial design should not be considered a 16-arm trial in which each condition is compared to a control condition. Our interest is in determining the optimal change in glycaemic control (time in range) from any combination of the four candidate intervention components. This involves estimating both main and interaction effects from a regression model with time in range as the outcome variable. Using effect coding (where each component is coded as 1 [received intervention] or -1 [did not receive intervention]), the main and interaction effects will be uncorrelated, and therefore are similarly powered. The main effects inform how effective each component is on glycaemic control, while interaction effects inform how the components enhance or diminish the effects when together.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
2/11/2020
Actual
30/10/2020
Date of last participant enrolment
Anticipated
Actual
6/07/2022
Date of last data collection
Anticipated
Actual
7/09/2022
Sample size
Target
80
Accrual to date
Final
20
Recruitment outside Australia
Country [1] 22820 0
New Zealand
State/province [1] 22820 0

Funding & Sponsors
Funding source category [1] 306412 0
Charities/Societies/Foundations
Name [1] 306412 0
Lottery Health Research
Country [1] 306412 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 306924 0
None
Name [1] 306924 0
Address [1] 306924 0
Country [1] 306924 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306610 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 306610 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306610 0
New Zealand
Date submitted for ethics approval [1] 306610 0
05/08/2020
Approval date [1] 306610 0
01/10/2020
Ethics approval number [1] 306610 0
20/NTA/127

Summary
Brief summary
The goal of the OPTIMISE Study is to identify the best combination of candidate intervention components that improve short-term glycaemic control (as measured by daily “Time in Range” over 14 days) by at least 5%. The effectiveness of the ‘optimised’ multicomponent intervention for improving longer-term glycaemic control will be evaluated in a future randomised controlled trial.

The OPTIMISE Study is an optimization trial that will recruit 80 adolescents and young adults (ages 13-20 years, inclusive) with type 1 diabetes and above target glycaemic control (mean HbA1c of at least 58 mmol/mol in the previous 6 months) from 6 New Zealand diabetes services (Auckland, Canterbury, Capital and Coast, MidCentral, South Canterbury and Southern District Health Boards). Participants will be randomised to one of 16 conditions in a factorial design involving four factors with two levels: continuous glucose monitoring technology (Yes vs No), snacking education (Yes vs No), tailored sleep extension (Yes vs No), and values-guided self-management (Yes vs No). The study will examine the effects of the components on short-term glycaemic control at 4 weeks post-intervention commencement. The components that together optimise short-term glycaemic control will become the multicomponent intervention to be evaluated in a future randomised controlled trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104454 0
Dr Sara Boucher
Address 104454 0
Department of Women's and Children's Health
University of Otago
PO Box 56
Dunedin 9054
Country 104454 0
New Zealand
Phone 104454 0
+64 3 470 9476
Fax 104454 0
Email 104454 0
[email protected]
Contact person for public queries
Name 104455 0
Dr Sara Boucher
Address 104455 0
Department of Women's and Children's Health
University of Otago
PO Box 56
Dunedin 9054
Country 104455 0
New Zealand
Phone 104455 0
+64 3 470 9476
Fax 104455 0
Email 104455 0
[email protected]
Contact person for scientific queries
Name 104456 0
Dr Sara Boucher
Address 104456 0
Department of Women's and Children's Health
University of Otago
PO Box 56
Dunedin 9054
Country 104456 0
New Zealand
Phone 104456 0
+64 3 470 9476
Fax 104456 0
Email 104456 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified demographic, glucose, diabetes management, sleep, snacking and psychosocial data will be shared as part of scientific peer review for publication and de-identified data underlying published results.
When will data be available (start and end dates)?
After the first paper has been submitted for peer view (approximately after 1 June 2022) and until 10 years after the youngest participant turns 16 (approximately 31 December 2034).
Available to whom?
Peer reviewers and external investigators who submit a written proposal to Dr Boucher outlining the question they will investigate, the specific variables they need to answer that question, their analytic plan for answering that question, and evidence of both satisfactory peer review and full ethical approval. Investigators must agree not to share the data with anyone else.
Available for what types of analyses?
To achieve aims in the approved research proposal.
How or where can data be obtained?
Proposals should be directed to [email protected]. Data will be sent through a file-sharing platform and will be password-protected.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8752Informed consent form  [email protected]
8753Ethical approval  [email protected]



Results publications and other study-related documents

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