The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000007134p
Ethics application status
Submitted, not yet approved
Date submitted
24/10/2018
Date registered
8/01/2019
Date last updated
8/01/2019
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized cross over trial comparing advanced hybrid closed loop mode with sensor augmented pump therapy in type 1 diabetes.
Scientific title
Randomized cross over trial comparing advanced hybrid closed loop mode with sensor augmented pump therapy in type 1 diabetes.
Secondary ID [1] 296232 0
Nil
Universal Trial Number (UTN)
U1111-1222-6769
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 309871 0
Condition category
Condition code
Metabolic and Endocrine 308665 308665 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, open label, two sequence cross-over study. Comparing MiniMed 670G insulin pump running in advanced hybrid closed loop (AHCL) mode with sensor augmented pump (SAP) therapy with predictive low-glucose management (PLGM)

MINIMED™ 670G INSULIN PUMP
The MiniMed™ 670G is an automated insulin delivery device approved in the United States for use in T1DM in individuals aged above 7 years. The pump is worn and delivers insulin continuously as at a 'basal rate' with additional bolus doses to cover food consumed. Insulin is administered from the pump via tubing into the subcutaneous tissue.

A non-controlled pivotal safety study in patients aged 14 – 75 years (n = 124) for 3 months demonstrated safety; in addition, diabetes control was improved and participants HbA1c reduced from 7.4% to 6.9% (1). Adolescent participants used the automated insulin delivery feature (“automode”) 75.8% of the time, with an observed change in HbA1c from 7.7%± 0.8% to 7.1%± 0.6% (2).

The algorithm that governs automated insulin delivery, and the parameters within it can operate have further been refined, designed to further improve glycaemic outcomes and the user experience. This is defined as advanced hybrid closed loop mode hereinafter.

This cross-over trial will utilise the MiniMed™ 670G, coupled with a CONTOUR NEXT LINK wireless blood glucose meter, 4th generation glucose sensor and GST3C transmitter. The glucose sensor is worn continuously on the skin and the subcutaneous tissue is sampled. The transmitter sends sensor glucose data wirelessly every 5 min to the pump, providing real-time glucose measurements and trends. Calibration of the glucose sensor is required with the CONTOUR NEXT LINK blood glucose meter at least once every 12 h. Blood glucose meters require patients to use a lancet to obtain a drop of capillary blood.

The pump is uploaded to transfer information to Medtronic CareLink therapy Management Software through the use of CONTOUR NEXT LINK glucose meter, which is also the uploading device.

ADVANCED HYBRID CLOSED LOOP MODE
One arm of the study will assess the MiniMed™ 670G running in advanced hybrid closed loop (AHCL) mode. The closed loop algorithm is contained in the MiniMed™ 670G, using a modified proportional integrative derivative (PID) model, with insulin feedback and additional safety features.

The algorithm receives continuous glucose monitoring (CGM) data every 5 minutes, and a “basal rate” insulin delivery is computed and adjusted every five minutes. Therefore, standard “basal” insulin that is pre-programmed in regular insulin pump therapy is replaced by the algorithm derived insulin delivery (given as a micro-bolus every 5 minutes).
Meals will be announced, and an insulin bolus delivered according to the individualised patient carbohydrate ratio and insulin sensitivity factor (should a correction bolus be required in addition to the insulin for carbohydrate).

SENSOR AUGMENTED PUMP THERAPY WITH PREDICTIVE LOW GLUCOSE MANAGEMENT
For the remainder of the study, the MiniMed™ 670G will run in Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM).
The ‘Suspend before low’ SmartGuard function suspends basal insulin infusion when sensor glucose is predicted to fall below the set low limit in 30 min. The pump suspends basal insulin infusion when two criteria are met:

1. Sensor glucose is at or within 3.9 mmol/L above the set low limit, and;
2. Sensor glucose is predicted to be 1.1 mmol/L above the set low limit in 30 min.
In the current study the low limit is set at 3.4 mmol/L. The pump will thus suspend insulin infusion when the sensor glucose is less than 7.3 mmol/L (3.9 + 3.4) and predicted to be 4.5 mmol/L (3.4 + 1.1) in 30 min.
If the ‘alert before low’ function is selected, the patient will receive an alert when insulin delivery is suspended.
In the absence of any participant interaction, the insulin infusion will resume after a maximum suspend period of 2 h or according to the auto-resumption parameters. Basal insulin will automatically resume if sensor glucose is above the low limit and trending upward, and insulin has been suspended for at least 30 min. However, the infusion may be resumed earlier if the patient intervenes during the suspend time and overrides the suspend function.


STUDY DESIGN
This is a randomised, open-label, two-sequence cross-over study.
Participants will be allocated to one of two treatment sequences (AB or BA) on a 1:1 basis. Treatments are as follows:
A. MiniMed™ 670G insulin pump running in AHCL mode
B. MiniMed™ 670G insulin pump running as SAP with PLGM

Each treatment period is of 4 weeks duration, with a two-week washout between treatments.
Study duration is expected to be 12 weeks. Five visits to the study centre are planned:
Day 1: Screening / baseline
Day 14: Randomization and start of Treatment Period 1
Day 42: End of Treatment Period 1
Day 56: Start of Treatment Period 2
Day 84: End of Study
During the study participants will be required to upload their insulin pumps on a weekly basis. On initiation of auto-mode, participants will be required to upload daily for the first seven days.

Up to approximately 46 subjects will be enrolled into the study. Additional subjects may be enrolled at the Investigator’s discretion to replace individual subjects who withdraw from the study prematurely or who do not complete required assessments.

References
1. Hovorka R, Elleri D, Thabit H, Allen JM, Leelarathna L, El-Khairi R, et al. Overnight closed-loop insulin delivery in young people with type 1 diabetes: a free-living, randomized clinical trial. Diabetes Care. 2014; 37:1204-11.
2. de Bock MI, Roy A, Cooper MN, Dart JA, Berthold CL, Retterath AJ, et al. Feasibility of Outpatient 24-Hour Closed-Loop Insulin Delivery. Diabetes care. 2015; 38:e186-e7

Intervention code [1] 312559 0
Treatment: Devices
Comparator / control treatment
MiniMed™ 670G insulin pump running as SAP with PLGM
Control group
Active

Outcomes
Primary outcome [1] 307624 0
Time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) obtained with:
- The MiniMed™ 670G insulin pump running in advanced hybrid closed loop (AHCL) mode
- The MiniMed™ 670G insulin pump running as sensor augmented pump therapy (SAP) with predictive low-glucose management (PLGM)

Timepoint [1] 307624 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Primary outcome [2] 307625 0
Time spent in hyperglycaemic range (sensor glucose level > 10 mmol/L) obtained with:
- The MiniMed™ 670G insulin pump running in AHCL mode
- The MiniMed™ 670G insulin pump running as SAP therapy with PLGM
Timepoint [2] 307625 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Secondary outcome [1] 352450 0
Time spent with blood glucose level less than 3.9 mmol/L MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
All glycaemic outcomes differentiated as 24 hrs, day (0600-2159 hrs) and night (2200-0559 hrs)
Timepoint [1] 352450 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Secondary outcome [2] 352451 0
Percentage time spent in auto-mode with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.

Timepoint [2] 352451 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Secondary outcome [3] 352452 0
Human-technology interaction assessed with device experience questionnaire (diabetes treatment satisfaction questionnaire (DTSQ) with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
Human-technology interaction assessed with device experience questionnaire (diabetes treatment satisfaction questionnaire (DTSQ):
- 8 questions
- answered on scale -3 to 3
Timepoint [3] 352452 0
Questionnaire administered at baseline and day 28 and day 70 for previous 28 days
Secondary outcome [4] 352453 0
Sleep quality assessed using Pittsburgh sleep quality index with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
Pittsburgh sleep quality index:
- 4 questions requiring 1 sentence answer
- 4 questions requiring frequency of sleep behaviours in last month
Timepoint [4] 352453 0
Questionnaire completed at baseline and on day 28 and day 70 for previous 28 days
Secondary outcome [5] 352845 0
Eating behaviours assessed by 3 day food recorded on smart phone application and analysed in Foodworks software with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM with regards to eating behaviours
Timepoint [5] 352845 0
Completed during first week of run period, day 25,26,27, 67,68,and 69.
Secondary outcome [6] 352846 0
Fear of hypoglycaemia assessed with adult low blood sugar survey with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
Adult low blood sugar survey: 11 questions regarding fear of hypoglycaemia, answered on scale 0-4
Timepoint [6] 352846 0
Survey completed at baseline and on day 28 and day 70 for previous 28 days
Secondary outcome [7] 354425 0
Time spent with blood glucose level less than 2.5 mmol/L MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
All glycaemic outcomes differentiated as 24 hrs, day (0600-2159 hrs) and night (2200-0559 hrs)
Timepoint [7] 354425 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Secondary outcome [8] 354426 0
Time spent with blood glucose level greater than 15 mmol/L MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
All glycaemic outcomes differentiated as 24 hrs, day (0600-2159 hrs) and night (2200-0559 hrs)
Timepoint [8] 354426 0
Two 4 week treatment periods ( day 15-42 and 57-84)
Secondary outcome [9] 354427 0
Alarm frequency with MiniMed™ 670G insulin pump running in AHCL mode versus SAP+PLGM.
Timepoint [9] 354427 0
Two 4 week treatment periods ( day 15-42 and 57-84)

Eligibility
Key inclusion criteria
Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
On insulin pump therapy for at least 6 months prior to study Day 1.
Willing and able to adhere to the study protocol.
Minimum age
14 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
2. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
3. History or current evidence of seizure disorder, renal impairment or cardiovascular disease, including uncontrolled hypertension.
4. History of severe visual impairment
5. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test on Study Day 1 is exclusionary.
6. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

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)
open label
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
sealed envolpe (website)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Device Training
Eligible subjects will receive training in the use of the Minimed™ 670G insulin pump and continuous glucose monitoring (CGM).
Subjects will be provided with the Minimed™ 670G, the Bayer CONTOUR® NEXT LINK 2.4, and CONTOUR PLUS test strips.
Run-in Period
Subjects will use the Minimed™ 670G insulin pump in SAP mode for a two-week period. This provides an opportunity for subjects to become familiar with the device; for control to be optimised if required; and for baseline glycaemic data to be collected.




CRITERIA FOR PREMATURE WITHDRAWAL
Subjects have the right to withdraw from the study at any time for any reason.
When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without their consent. The investigator may withdraw subjects from the study in the event of inter-current illness, adverse events (AEs), lack of compliance with the study or study procedures (e.g., product administration instructions, study visits) or any other reason where the investigator feels it is in the best interest of the subject. This explicitly includes the use of AHCL out of study sequence.
Reasons for withdrawal must be documented and explained to the subject. It is understood by all concerned that an excessive rate of withdrawals can render the study uninterpretable; therefore, unnecessary withdrawal of subjects should be avoided.
The investigator should contact the subject or a responsible relative either by telephone or email to determine as completely as possible the reason for the withdrawal.
If the reason for removal of a subject from the study is an AE, the principal specific event must be recorded in the CRF. The subject should be followed until the AE is resolved or returns to baseline, if possible.

ADVERSE EVENTS
An Adverse Event (AE) is any untoward medical occurrence in a subject exposed to the products trialled in the current study and which does not necessarily have to have a causal relationship with the intervention. An AE can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of the products, whether or not considered related to the product. Pre-existing conditions that worsen during a study are to be reported as AEs.
All clinical AEs encountered from initial product use until completion of the final study assessments will be entered in the CRF.
Relationship of the AE to products should be assessed. Intensity of AEs will be graded on a four–point scale (mild, moderate, severe and life threatening) and reported in detail as indicated in the CRF:
Mild: discomfort noticed but no disruption of normal daily activity.
Moderate: discomfort sufficient to reduce or affect daily activity.
Severe: inability to work or perform normal daily activity.
Life Threatening: represents an immediate threat to life.

HANDLING OF SAFETY DATA
Serious Adverse Events (Immediately Reportable to the Sponsor)
An SAE is any experience that suggests a significant hazard, contraindication, side effector precaution. An SAE must fulfil at least one of the following criteria:
Is fatal (results in the outcome death);
Is life-threatening;
Requires in-patient hospitalization or prolongation of existing hospitalization;
Results in persistent or significant disability/incapacity;
Is a congenital anomaly/birth defect;
Is medically significant or requires intervention to prevent an outcome listed above.
Any AE that is serious must be reported to the Sponsor within one working day of its occurrence (expedited reporting).
Treatment and Follow-up of Adverse Events
All adverse events, regardless of the relationship of the event to the study product, should be followed up until they have returned to baseline status or stabilized. If return to baseline status or stabilization cannot be established an explanation should be recorded in the CRF.

STUDY STOPPING RULES
Enrolment of subjects will be halted in the event of any of the following:
1. Recurrent severe hypoglycaemia in one or more subjects, due to algorithm-derived insulin delivery;
2. Recurrent diabetic ketoacidosis in one or more subjects, due to algorithm-driven disruption of insulin delivery;
3. Recurrent hardware malfunction in one or more devices, that places subjects at risk of (1) or (2).

INVESTIGATOR’S FILES / RETENTION OF DOCUMENTS
The Investigator must maintain adequate and accurate records to enable the conduct of the study to be fully documented and the study data to be subsequently verified. These documents should be classified into two different separate categories:
1. Investigator’s Study File;
2. Subject clinical source documents.
The Investigator’s Study File will contain the protocol/amendments, HDEC approval with correspondence, sample participant information sheet and informed consent documents, study product records, staff curriculum vitae and authorization forms and other appropriate documents/correspondence, etc.
Subject clinical source documents may include a subject workbook, physician’s and nurse’s notes, original laboratory reports, ECG, signed informed consent forms, and subject screening and enrolment logs.
The Investigator must keep these two categories of documents on file for at least 15 years after completion or discontinuation of the study, subject to local regulations.


Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Statistical Analysis
The analyses and summaries of the presenting and outcome features will be conducted on the intention to treat (ITT) population. All analyses will report two-tailed p-values with no adjustment for multiple comparisons. Both co-primary efficacy measures are required to show a statistically significant advantage to the ACHL intervention for the study to support further use or research for this intervention.
All analyses of efficacy will incorporate the between-subject treatment randomisation sequence as a factor in the models to test that the sequence of treatments does not effect the relative efficacy of the treatments.
All available data from the two 28-day treatment periods will be used to estimate the % glycaemic data for all analyses. It is not required that all data over the 28 days for each treatment is available to enable estimation of these measures.
Preliminary data on the % time in the target range and % time in the hyperglycaemic range indicates that these measures are sufficiently normal to allow parametric statistical analyses to compare the randomised interventions. These assumptions will be confirmed prior to any analyses and if these are not met after transformation then appropriate non-parametric comparisons will be utilised.
Descriptive Summaries
Baseline demographic, clinical and presenting features for outcome measures will be summarised for the whole ITT population using means, medians, ranges, IQRs and frequencies and percentages as appropriate. No hypothesis testing will be undertaken on these summaries.
Hypothesis Testing
The two primary outcome measures; percentage CGM time in target sensor glucose range and the percentage CGM time greater than 10 mmol/L will be compared between randomised groups using a general linear mixed model. This model will include participant as a random effect, randomised treatment as a within subject fixed factor, treatment sequence as a between subject factor and the interaction between randomised treatment and treatment sequence factors. If the interaction term has a p-value greater than 0.15 then this term will be excluded from the final model.
The difference between randomised treatments and 95% confidence interval will be derived from this model and will be used to summarise the relative treatment effects.
The secondary outcome measures summarising glycaemic control will also be compared between randomised groups using the same model as used for the primary outcomes.
The secondary outcomes relating to the psycho-social factors and the device questionnaires collected at the end of each of the 28-day interventions will be compared between randomised groups using the general linear mixed model with the same factors as used for the primary efficacy measures.
Sensitivity analyses of the glycaemic control measures will be undertaken using the per-protocol population as defined below
Missing data
All ITT analyses will incorporate all available data, the full analysis set, and there will be on imputation of missing data. For the general linear mixed models participants are not required to have both interventions to be included in the analyses.

ANALYSIS POPULATIONS
Safety Analysis Population
All subjects who have used the study device, whether prematurely withdrawn from the study or not, will be included in the safety analysis population.
Intent-to-Treat Population
All subjects who complete the screening process and are enrolled into the study (i.e. assigned to a treatment sequence) are included in the Intent-to-Treat (ITT) population. This population is the primary analysis population for all non-safety related analyses.
Per-protocol Population
Subset of the ITT population who meet all inclusion and exclusion criteria and have complete CGM data will be included in the Per-Protocol (PP) population. The PP population may also include subjects who do not meet all inclusion and exclusion criteria as long as the eligibility criteria in question did not impact study related endpoints. All decisions on subject exclusions from the PP population will be made prior to database closure and will be justified in the clinical study report.
SAFETY DATA ANALYSIS
All safety analyses will be based on the safety analysis population
Adverse Events
The original term(s) recorded in the CRF by the investigator for adverse events will be standardized by assigning preferred terms from the Medical Dictionary for Drug Regulatory Affairs (MedDRA). Adverse events will be described by individual listings and frequency tables broken down by body system and reported as frequencies and incidences by randomised treatment.
Vital Signs
Vital signs data will be presented by individual listings with flagging of values outside the normal ranges and flagging of marked abnormalities. Tabular summaries may be used, as appropriate, summarising changes by randomised treatment.
Concomitant Medications
The original term(s) recorded in the CRF by the investigator for concomitant medications will be
standardized by assigning preferred terms from the “INN (international non-proprietary name) drug terms and procedures dictionary for treatments and surgical and medical procedures”. Concomitant medications may be presented in summary tables and listings.
SAMPLE SIZE
Using baseline data from two previously conducted studies the mean % time in the Target range varied from approximately 50% to 70% with a SD of 12%. The mean times in the hyperglycaemic range varied from approximately 30% to 40% with a SD of 14%. Data from a recent meta-analysis of closed loop studies demonstrated a mean absolute improvement in the percentage of time in the target glycaemic range of more than 10%, and a similar decrease (8%) in the percentage time in the hyperglycaemic range. Using a two-tailed comparison, and a set at 0.05, a sample size of 40 subjects will have in excess of 90% power to detect a difference of >7.5% as statistically significant for either comparison. For the study to achieve its primary efficacy objective both co-primaries will need to show a statistically significant improvement for ACHL over the SAP with PLGM comparator.
REPLACEMENT POLICY
Subjects prematurely discontinued from the study may be replaced to ensure adequate numbers of evaluable subjects. Subject replacement numbers will be provided by the site. The replacement will be given the number of the withdrawn subject plus 100 e.g. Subject No. 003 would be replaced by Subject 103 and, if necessary, further replaced by Subject 203 etc. The decision to replace a withdrawn subject will be made at the discretion of the Sponsor and the Investigator.

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] 20890 0
New Zealand
State/province [1] 20890 0
Canterbury and Otago

Funding & Sponsors
Funding source category [1] 300832 0
Commercial sector/Industry
Name [1] 300832 0
Medtronic
Address [1] 300832 0
Medtronic Inc
18000 Devonshire St, Northridge, CA 91325, USA
Country [1] 300832 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Inc
Address
18000 Devonshire St, Northridge, CA 91325, USA
Country
United States of America
Secondary sponsor category [1] 300430 0
None
Name [1] 300430 0
none
Address [1] 300430 0
Country [1] 300430 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 301601 0
Health and disability ethics committee
Ethics committee address [1] 301601 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 301601 0
New Zealand
Date submitted for ethics approval [1] 301601 0
31/10/2018
Approval date [1] 301601 0
Ethics approval number [1] 301601 0

Summary
Brief summary
Randomised, open label, two sequence cross-over study. Comparing MiniMed 670G insulin pump running in advanced hybrid closed loop (AHCL) mode with sensor augmented pump (SAP) therapy with predictive low-glucose management (PLGM) in patients with type 1 diabetes.
The primary outcomes are to compare the proportion of time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) and proportion of time in hyperglycaemic range (sensor level glucose >10 mmol/L) obtained with:
- The MiniMed™ 670G insulin pump running in advanced hybrid closed loop (AHCL) mode
- The MiniMed™ 670G insulin pump running as sensor augmented pump therapy (SAP) with predictive low-glucose management (PLGM).
Secondary outcomes include the human technology interaction, sleep quality, fear of hypoglycaemia and eating behaviours which will be assessed with questionnaires. The study will recruit up to 46 patients with type one diabetes who are on an insulin pump and run for 84 days. Study participants will use the pump in both AHCL mode and SAP with PLGM mode for 4 weeks each separated by a 14 day washout period. During the study participants will be required to upload their insulin pumps on a weekly basis. On initiation of auto-mode, participants will be required to upload daily for the first seven days. The study will be conducted in Canterbury and Otago.
Trial website
Trial related presentations / publications
Public notes
This is a collaborative study with Medtronic, and is not classified as a commercial trial with respect to IRB (ethical) approval. There are no restrictions from either party for publication purposes (either Medtronic, or the investigators).

Contacts
Principal investigator
Name 87514 0
Dr Martin de Bock
Address 87514 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue, PO4345
Christchurch 8140
Country 87514 0
New Zealand
Phone 87514 0
+64 3 372 6763
Fax 87514 0
+64 3 365 9133
Email 87514 0
martin.debock@otago.ac.nz
Contact person for public queries
Name 87515 0
Dr Martin de Bock
Address 87515 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue, PO4345
Christchurch 8140
Country 87515 0
New Zealand
Phone 87515 0
+64 3 364 0640
Fax 87515 0
+64 3 365 9133
Email 87515 0
martin.debock@otago.ac.nz
Contact person for scientific queries
Name 87516 0
Dr Martin de Bock
Address 87516 0
Department of Paediatrics
University of Otago, Christchurch
2 Riccarton Avenue, PO4345
Christchurch 8140
Country 87516 0
New Zealand
Phone 87516 0
+64 3 364 0640
Fax 87516 0
+64 3 365 9133
Email 87516 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
What supporting documents are/will be available?
No other documents available
Summary results
Not applicable