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Trial registered on ANZCTR


Registration number
ACTRN12620000034932p
Ethics application status
Submitted, not yet approved
Date submitted
19/11/2019
Date registered
20/01/2020
Date last updated
20/01/2020
Date data sharing statement initially provided
20/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing efficacy and safety of Automated Insulin Delivery utilizing open source technology in children and adults with Type 1 Diabetes
Scientific title
Randomised parallel arm open label clinical trial comparing automated insulin delivery using an open-source algorithm (AnyDANA-loop), with sensor augmented pump therapy in type 1 diabetes.
Secondary ID [1] 299770 0
CREATE-0001
Universal Trial Number (UTN)
U1111-1243-2843
Trial acronym
CREATE (Community deRivEd AutomaTEd insulin delivery) trial
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 315133 0
Condition category
Condition code
Metabolic and Endocrine 313454 313454 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is the DANA-I™ insulin pump running in Automated Insulin Delivery (AID) mode.
Following the 4-week run-in phase, participants will be randomly allocated to one of two treatment sequences (AA or BA) on a 1:1 basis. Treatments are as follows:
A. DANA-I™ insulin pump running in AID mode (AnyDANA-loop)
B. DANA-I™ insulin pump running as Sensor Augmented Pump Therapy (SAPT)
After the 6-month RCT phase all participants will be invited into a 6-month continuation phase and those initially randomised to SAPT cross into the AID arm.

A locked version of the OpenAPS algorithm will be used and installed as an app on an Android phone (participants will be provided with this if they do not possess their own Android phone). Combined with data from the Dexcom G6 Continuous Glucose Monitor (CGM) and pump, this study AID system will be known as the “AnyDANA-loop”. This system is designed to make safe, temporary adjustments to basal insulin rates in order to maximise the time in target glucose range (3.9 - 10.0 mmol/L) and minimise the risk of hypoglycaemia. In the case of failure of the system (such as phone/app failure), the pump will alert the user and switch to standard pump therapy. The algorithm is a simple, but effective, rules-based heuristic algorithm that closely matches what a patient would do to manage their diabetes. The algorithm makes micro-adjustments to the doses of insulin delivered every five minutes using predictions from previously inputted data and variables (such as previous insulin dosing, carbohydrate intake, CGM trend, etc.).

Study Devices: All devices have been previously used in humans. The DANA-I Insulin Pump is not commercially available in New Zealand. The Dexcom 6 CGM is commercially available in New Zealand. One investigational device per participant will be used. In the event of device malfunction or accidental damage, the investigative team will replace the participant’s device.

1. The DANA-I™ Insulin Pump is intended for the subcutaneous delivery of insulin for the treatment of type 1 diabetes. It is a software-controlled, programmable insulin infusion pump capable of both basal and bolus insulin delivery.
The DANA-I™ Insulin Pump is designed to hold up to 3mL, or 300 units of insulin. The reservoir is a sterile, single-use, non-pyrogenic syringe that is designed for use with the DANA Insulin pump. The syringe is designed to be replaced at least once every three days.
The user enters the amount of carbohydrates to be consumed prior to bolus delivery. The pump algorithm uses the blood glucose value, the carbohydrate value, and the target blood glucose level to calculate the bolus of insulin required.
The maximum basal rate is 16u/hr, and basal frequency is four minutes. Temporary basal rates range from 0-200% and can run from one-24 hours. The DANA-I™ Insulin Pump weighs 86g and is currently licensed for NovoLog insulin only. It is water resistant, and battery operated with AAA alkaline batteries.

2. The AnyDANA-loop algorithm runs as an application on an Android phone, which communicates directly via Bluetooth with the insulin pump and CGM. The system reviews what sensor glucose levels are/have been doing and with the pump to read history and determine how much insulin has been delivered in the past. The system then calculates any needed insulin adjustments and commands the pump accordingly. The CGM data and the changes of insulin delivery, including temporary basals, pump status, and other system-related calculations, are visualised on the smartphone. Participants randomised to the AID arm will use AID mode continuously for the 6 months RCT duration.
Individual data including all pump settings will be pushed from the Android phone into two cloud based servers; Dexcom Clarity and Nightscout so study staff can assess percentage of time spent in AID mode, a formal statistical analysis will assess this. Also, participants in the AID arm will be invited to attend individual interviews following completion of the RCT phase to explore usability and acceptability of the AID system. Furthermore, their will be ongoing content analysis of online, peer-to-peer learning of AID participants. Topics of the online posts might include basic functioning of AID, trouble-shooting AID problems, modifying settings, advanced use of AID, impact of AID, psycho-social aspects...

3. The Dexcom G6 is factory calibrated and approved for 10 days use. The Dexcom G6 is inserted subcutaneously by the participants. It provides interstitial glucose readings every five minutes, which are transmitted to the receiver – in this case an android phone (which we will provide). The G6 is the most accurate CGM system available worldwide and is approved for non-adjunctive use – that is the sensor glucose values are not required to be verified with capillary glucose monitoring for insulin dosing.

As AnyDANA-loop has been developed from open-source innovations, there is no formal patient education or training associated with the system. We will however provide our own learning guide during the education process. In considering how open-source innovations can be developed into approved health care devices, translational strategies must be developed to ensure effective learning of the system by both patients and health care practitioners. The AnyDANA-loop trial will use both formal clinical education and informal online peer-to-peer learning. Participants in the intervention (AID) arm will receive educational brochures (there are 4 of these covering basics through to advanced use of AID) which will outline their responsibilities/ roles also.
These include:
- inserting the CGM and following instructions for good use, which may include occasional calibrations
- completing insulin pump set changes and renewing insulin
- keeping the phone charged
- entering carbohydrate counts and bolusing for meals
- troubleshooting issues such as site or pump failure (just like with standard pump therapy)
- they may need to spend some time refining basal rates, I:C ratio(s) and ISF(s)
They will also be invited to join a closed online community (Tribe Technologies Inc.) of participants in the trial, for ongoing consumer-driven peer support. This will simulate the community support that is used by existing do-it-yourself OpenAPS users. For participants under 16 years old, parents will be invited to join the community, rather than the child.
Participants will be identified in online communities by either their study ID number or a pseudonym of their choice and provided with advice about how to maintain anonymity within these groups. They will also be provided with guidelines covering etiquette for constructive participation in online groups and appropriate topics to post to their community. Online communities will be monitored by investigative staff who will review new posts on a regular basis (maximum of 48 hours between reviews).
Intervention code [1] 316024 0
Treatment: Devices
Comparator / control treatment
SAPT is the most advanced system currently available in New Zealand for the treatment of T1D. Participants randomised to the SAPT group will also use the AnyDANA-loop app on the phone. Access to AnyDANA-loop will be limited to only setting high and low sensor glucose alerts, but the use of the AID algorithm will be disabled. The use of the AnyDANA-loop app in both arms is so the pump and glycaemic data is identical in both groups.
Control group
Active

Outcomes
Primary outcome [1] 321924 0
The primary outcome, mean percentage of time spent in target glucose range (3.9 to 10.0 mmol/L) will be collected from days 155 – 168 (last 2 weeks of the RCT phase), and will be calculated for each participant by dividing the number of CGM measures within range by the total number of CGM measures recorded.
Timepoint [1] 321924 0
The randomised clinical trial phase is 6-months duration, with the primary outcome will be measured at the end of this phase (day 168).
Secondary outcome [1] 376717 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to:
Glycaemic Control by measuring HbA1c 3 monthly (in clinics) during the RCT and continuation phase and assessment of continuous glucose monitor (CGM) data, determining % CGM time 3.0 - 3.9 mmol/L, % CGM time < 3.0 mmol/L, % CGM time < 2.6 mmol/L, % CGM time 10.1 -13.9 mmol/L, % CGM time >13.9 mmol/L.
This is a composite secondary outcome.
Timepoint [1] 376717 0
Glycaemic control based upon CGM data will be calculated for each participant for each adjacent 14 day block throughout the study (for example, day 1 to day 14, day 15 to day 28, …, day 155 to day 168). This data will be summarised as medians and quantiles by treatment group and time, and presented in figures.
Secondary outcome [2] 376718 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to experience of fear related to hypoglycemia using the Hypoglycaemia Fear Survey II, short form. Participants aged 7-17 years inclusive and their parent/ guardian will complete child and parent versions of the Hypoglycaemia Fear Survey (HFS II) respectively. Participants 18 years and older will complete the adult version.

Timepoint [2] 376718 0
This questionnaire will be completed at the baseline visit, at the end of the RCT phase and again at the end of the Continuation Phase.
Secondary outcome [3] 376719 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to:
Platform Performance. This will be assessed by measuring the percentage of time participants randomised to the AID arm are using AID mode. This data will be available and pulled from the cloud based severs- Nightscout and Dexcom Clarity. Platform performance will also be gauged by documenting any software and/ or hardware technical issues which participants can flag to study staff at any time during the entire study duration. Such issues will also be asked at clinic visits (at least 6 scheduled during the study), raised in the individual interviews (to occur after the RCT phase) for those who consent to participate in these and may also become apparent from analysis of the online peer-peer discussions.
Timepoint [3] 376719 0
Continuous throughout the RCT and Continuation Phase.
Secondary outcome [4] 376720 0
A secondary (composite) objective of this study is to evaluate the effectiveness of the Human-Technology Interaction for both participants using AID mode as well as healthcare professionals (HCPs).
This will be assessed by:
- ongoing content/ thematic analysis of online, peer-to-peer learning of participants to assess topics posted (i.e., basic functioning of AID, troubleshooting AID problems, Advanced AID use, tips and tricks for using AID, impact of AID, celebration of successes and sharing of difficulties), frequency of posts, study ID initiating posts and responding to posts (in order to establish a profile superusers including their glycaemic control and demographic characteristics).
- ongoing content analysis of online, peer-to-peer learning of HCPs ( (Slack Technologies Ltd, 2018) will assess frequency of posts by channel over time by HCP and Investigators, frequency of specific words in posts over time and conversation length. Analysis will focus on the topics being discussed and changes in frequency of topic, and frequency with which NI’s Crocket and Lewis provide answers vs other Healthcare Professionals providing answers over the duration of the trial.
- interviews with participants to assess their processes of learning and explore usability and acceptability of the intervention
- a focus group examining processes of learning amongst HCPs will focus on their experiences of supporting trial participants to use the AID system and the training materials provided.
- interviews with a selection of HCPs may be conducted at each site as the all participants randomised to AID complete the RCT phase to assess their experiences of supporting trial participants to use the AID system and the training materials provided.
- interviews with participants who discontinue the treatment (to occur within one month of the participant discontinuing the study) to assess usability and acceptability of the intervention.
Timepoint [4] 376720 0
Participant interviews will occur within 6 weeks of completing the RCT phase for those randomised to the AID arm. Thematic analysis will be undertaken on interview data.
HCP interviews to occur within one month of the site’s last subject completing the RCT phase.
There will be ongoing content and thematic analysis of online, peer-to-peer learning of participants and HCPs throughout the study duration.
HCP focus groups to occur within one month of all sites having 5 participants complete the first three months of the RCT phase
Interviews with participants who discontinue the treatment to occur within one month of the participant discontinuing the study.
Secondary outcome [5] 378035 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to:
Mean sensor glucose and glucose variability (expressed primarily as coefficient of variation and secondly as a SD)
Timepoint [5] 378035 0
This secondary outcome based upon CGM data will be calculated for each participant for each adjacent 14 day block throughout the study (for example, day 1 to day 14, day 15 to day 28, …, day 155 to day 168). This data will be summarised as medians and quantiles by treatment group and time, and presented in figures.
Secondary outcome [6] 378037 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to:
Glycaemic outcomes differentiated as 24 hours, day (0600-2159 hours) and night (2200-0559 hours)
Timepoint [6] 378037 0
This secondary outcome based upon CGM data will be calculated for each participant for each adjacent 14 day block throughout the study (for example, day 1 to day 14, day 15 to day 28, …, day 155 to day 168). This data will be summarised as medians and quantiles by treatment group and time, and presented in figures.
Secondary outcome [7] 378038 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to:
Severe Adverse Events (SAE) rate: Diabetic ketoacidosis, severe hypoglycaemia.
Timepoint [7] 378038 0
AE collection will occur continuously. Participants will have clear instructions to contact study staff for issues such as ketones or severe hypoglycaemia. Participants will specifically be asked about any potential AEs at each study visit (at least 6 visits are scheduled).
Secondary outcome [8] 378620 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to sleep quality using the Pittsburgh Sleep Quality Index in participants 13 years inclusive and older.
Timepoint [8] 378620 0
The PSQI will be completed at the baseline visit, at the end of the RCT phase and again at the end of the Continuation Phase.
Secondary outcome [9] 378621 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to participants current treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire status (DTSQs). A Parent version of the DTSQs will be completed for participants 7-12 years inclusive, participants 13-17 years inclusive will complete a teen version (parents can also do this) and the adult version is to be completed by participants 18 years inclusive and older.
Timepoint [9] 378621 0
The DTSQs will be completed at the baseline visit, at the end of the RCT phase and again at the end of the Continuation Phase.
Secondary outcome [10] 378622 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to health state (physical and mental) using the EuroQol 5-dimensional Questionnaire (EQ-5D). The EQ-5D-Y will be completed by participants 8-15 years inclusive. The EQ-5D-5L will be completed by participants 16 years inclusive and older. This questionnaire will not be completed by participants 7 years of age.
Timepoint [10] 378622 0
The EQ-5D will be completed at the baseline visit, at the end of the RCT phase and again at the end of the Continuation Phase.
Secondary outcome [11] 378623 0
A secondary objective of this study is to evaluate the effectiveness of the AnyDANA-loop platform relative to SAPT therapy, with regards to eating behaviors using the Research Food Diary app on four non-consecutive days (three weekdays and one weekend day).
Timepoint [11] 378623 0
Participants will be asked to complete the 4 day food diary during the 4 week run in period as well as in the last week of the RCT Phase.

Eligibility
Key inclusion criteria
Inclusion criteria:
1. Type 1 diabetes as per the American Diabetes Association classification for > 1 years prior to the Baseline Visit
2. Aged 7 - 70 years inclusive stratified into two groups (7 - 15 years inclusive and 16 - 70 years years inclusive) at Baseline
3. Currently on insulin pump therapy for > 6 months prior to the Baseline Visit
4. Mean HbA1c < 10.5% (91 mmol/mol) within 6 months prior to the Baseline Visit (minimum of one test)
5. Willing and able to adhere to the study protocol
6. Have daily access to a Wi-Fi network
Minimum age
7 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
1. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary
2. Alcohol or drug dependence
3. Severe visual impairment that would impair use of the device
4. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
5. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study
6. Allergic or intolerant to NovoRapid® insulin

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)
The randomisation list will be loaded into the REDCap (Research Data Capture) database by the study statistician immediately prior to moving the project to production status. Once the project is moved to production, the randomisation list is locked and becomes unmodifiable and inaccessible to the study team.
Participants may only be randomised once obtainment of consent has been verified and stratification variables entered into REDCap. Then research staff with authorisation to randomise participants may click the ‘randomise’ button, which will assign the treatment to the study number and lock the fields containing the treatment group and stratification variables. This process will ensure allocation is kept concealed from researcher staff and participants until after the participant has been enrolled.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study statistician will prepare a computer-generated randomisation list with an allocation ratio of 1:1 and permutated blocks of random size. The randomisation list will be stratified by participants’ age, baseline HbA1c (<8.1%/64mmol/mol and >8.0%/64mmol/mol), and study site to ensure these prognostic factors are balanced between groups.
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
Determination of Sample Size

The original sample size determination was N=160 (40 per group per strata). However, this calculation was based on several conservative assumptions that we have re-considered in order to determine our final study sample size of N=100 (25 per group per strata).
The study protocol clearly delineates our thinking which is summarised below:
- A sample size of 100 participants (50 adults and 50 children) will provide approximately 90% power to detect an overall treatment effect in the following scenarios:
- Non-differential treatment effect: The standard deviation of the outcome is 12.5 percentage points or less, the absolute treatment effect in adults and children is at least 10 percentage points (effect size = 0.8), and there is no more than 15% information loss due to participant dropout.
- Differential treatment effect: The standard deviation of the outcome is 10 percentage points or less, the absolute treatment effect in adults 10 percentage points (effect size = 1.0) and in children is 5 percentage points (effect size = 0.5), and there is no more than 15% information loss due to participant dropout.
- Unless very large, differences in treatment effectiveness between adults and children are likely to be undetectable even with the originally proposed sample size of N = 160.
- The ability to detect adverse events will be approximately halved, however, event rates as low as 3 per 100 person-years are still likely to be observed

Statistical Methods

The primary endpoint; mean percentage of time spent in target glucose range (3.9 to 10.0 mmol/L) between days 155 - 168 (RCT phase), will be calculated for each participant by dividing the number of CGM measures within range by the total number of CGM measures recorded. The overall treatment effect (primary outcome) shall be determined by using a global F-test (ANOVA) to compare a linear model containing age strata and treatment group and their interaction, versus the ‘null’ model containing age strata only. Simulation shows that this approach preserves the overall type 1 error rate, whilst allowing for investigation of treatment effects at a subgroup level. Group means and differences in group means will be estimated with 95% confidence intervals using ordinary least squares linear regression models with adjustment for stratification factors.
Continuous secondary endpoints will be calculated and compared in a similar manner. Where possible (for example for HbA1c and psychosocial factors), analysis of covariance (ANCOVA) models will be used to also adjust for participants’ levels at baseline. The stability of outcomes achieved by participants at day 168 (end of RCT phase) will be assessed by entering data collected during the continuation phase into likelihood-based linear mixed-effect models. The mean change and standard deviation of change in outcomes over time between days 168 - 336 (continuation phase) will be estimated with 95% confidence intervals, stratified by treatment group. Harms, for example adverse event (AE) and severe adverse event rates, will be grouped, tallied and reported.

Content (quantitative) and thematic (qualitative) analysis will be undertaken of interactions on both Healthcare Professionals (HCPs) and patients’ online platforms. Content analysis will be separately undertaken for HCPs’ and patients’ data sets as follows.
HCP’s use of a shared Slack Workspace (Slack Technologies Ltd, 2018) will be tracked using Excel (Microsoft Corporation Ltd, 2019). Data recorded will include: topic of questions being asked (i.e., basic functioning of AID, trouble-shooting AID problems, tips and tricks for using AID, impact of AID, psycho-social aspects), frequency of questions being asked, and whether answers are provided by other HCPs or by investigators with expertise in AnyDana-Loop (NI’s Crocket and Lewis). Analysis will focus on the topics being discussed and changes in frequency of topic, and ability of HCPs to answer questions over the duration of the trial.
Patient’s use of a shared, private online platform (Tribe Technologies Ltd, 2019) for peer-to-peer learning and support will be recorded using Excel (Microsoft Corporation Ltd, 2019). Data recorded will include: Study ID of patient initiating a post, topic of the post (i.e., basic functioning of AID, trouble-shooting AID problems, tips and tricks for using AID, impact of AID, psycho-social aspects), frequency of posts and frequency of responses to posts. Analysis will focus on the frequency of topics being posted in relation to the length of time the initial poster and responders have been participating in the trial.
Data for qualitative analysis from individual interviews (verbatim transcripts) and online platforms (screenshots of posts) will be imported into qualitative data management software Nvivo (QRS International Pty Ltd, 2014) for management, retrieval and interrogation by two researchers, including NI Crocket. Thematic analysis, as described by Braun and Clark, will be used. Coding will be undertaken inductively. Generation of themes from these codes will be informed by social-ecological theory and prior literature relating to human factors in AID use.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 22035 0
New Zealand
State/province [1] 22035 0
Christchurch, Canterbury
Country [2] 22036 0
New Zealand
State/province [2] 22036 0
Dunedin, Otago
Country [3] 22037 0
New Zealand
State/province [3] 22037 0
Auckland
Country [4] 22038 0
New Zealand
State/province [4] 22038 0
Hamilton, Waikato

Funding & Sponsors
Funding source category [1] 304236 0
Government body
Name [1] 304236 0
Health Research Council of New Zealand
Address [1] 304236 0
Level 3 - ProCARE Building, Grafton Mews, at 110 Stanley Street (GPS: 50 Grafton Road), Grafton, Auckland 1010
PO Box 5541, Wellesley Street, Auckland 1141
Country [1] 304236 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
362 Leith Street, North Dunedin, Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 304475 0
None
Name [1] 304475 0
Address [1] 304475 0
Country [1] 304475 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304696 0
Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 304696 0
Postal address:
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Street address:
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 304696 0
New Zealand
Date submitted for ethics approval [1] 304696 0
20/12/2019
Approval date [1] 304696 0
Ethics approval number [1] 304696 0

Summary
Brief summary
The CREATE (Community deRivEd AutomaTEd insulin delivery) Trial is a ground-breaking study in the treatment of type one diabetes. It is the first randomised controlled trial of an open-source, community-built algorithm for automated insulin delivery. The algorithm and app interface being tested is based on the OpenAPS algorithm and when combined with the DANA-I™ insulin pump and Dexcom G6 CGM, it is forms the AnyDANA-Loop automated insulin delivery system. This technology allows for automation of insulin delivery, improving control of blood glucose and reducing the burden of care for people with type one diabetes. The study of 100 participants will examine the safety and efficacy of AnyDANA-Loop in both children and adults across four tertiary diabetes centres in New Zealand.
The initial study will compare blood glucose control over 6 months of AnyDANA-Loop use compared to sensor augmented pump therapy (SAPT). A 6 month continuation phase will follow to better assess safety along with other secondary outcomes.
Trial website
https://www.otago.ac.nz/christchurch/departments/paediatrics/research/otago717634.html
Trial related presentations / publications
Public notes
An abstract for the CREATE Trial protocol has been submitted to ATTD. An E-Poster will be presented at the ATTD Conference in Madrid in February 2020. The protocol publication is in draft which we plan to submit to JDMD.

Contacts
Principal investigator
Name 97902 0
Dr Martin de Bock
Address 97902 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011


Country 97902 0
New Zealand
Phone 97902 0
+64 211 956 579
Fax 97902 0
Email 97902 0
Martin.debock@otago.ac.nz
Contact person for public queries
Name 97903 0
Dr Martin de Bock
Address 97903 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011


Country 97903 0
New Zealand
Phone 97903 0
+64 211 956 579
Fax 97903 0
Email 97903 0
Martin.debock@otago.ac.nz
Contact person for scientific queries
Name 97904 0
Dr Martin de Bock
Address 97904 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue
Christchurch 8011


Country 97904 0
New Zealand
Phone 97904 0
+64 211 956 579
Fax 97904 0
Email 97904 0
Martin.debock@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We recognise there is considerable debate around the ethics of data sharing with interventional trials. On the one hand, data sharing is a requisite for the successful democratisation of healthcare, however on the other hand there is an ethical obligation to share data responsibly in order to protect study participants. At this stage we do not plan to share data, however we will be guided by the likes of the National Ethics Advisory Committee and the soon to be released National Ethics Standards.
What supporting documents are/will be available?
No other documents available
Summary results
No Results