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Trial registered on ANZCTR
Registration number
ACTRN12619001452189
Ethics application status
Approved
Date submitted
25/09/2019
Date registered
18/10/2019
Date last updated
28/09/2023
Date data sharing statement initially provided
18/10/2019
Date results information initially provided
11/01/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control Aged 12-25
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Scientific title
The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control
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Secondary ID [1]
299409
0
Nil known
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Universal Trial Number (UTN)
U1111-1259-6423
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Trial acronym
HCL IGC
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes
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Poor Glycaemic Control
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Condition category
Condition code
Metabolic and Endocrine
312924
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This is a prospective multicentre randomized controlled, two-arm unblinded, parallel study in free-living conditions, in adolescents with type 1 diabetes on insulin pump therapy.
Participants are randomized in two groups; either the control group (standard therapy) or the intervention group (hybrid closed loop, HCL). The control group will be participants on insulin pump therapy with or without continuous glucose monitoring (CGM).
Intervention arm: Medtronic Advanced HCL system for 6 months (8 in-clinic visits in 6 months)
OR
Control arm: Standard care for 6 months (7 in-clinic visits in 6 months)
This will be followed by an optional extension phase for another 6 months when those in the control arm would crossover to the intervention arm.
In view of the recall on insulin pumps with clear retainer rings, the study will use the 780G insulin pump with the same algorithm, which has the added feature of bluetooth wireless communication with the compatible devices in the MiniMedTM 780G System connectivity.
The MiniMedTM 780G Pump works with the following major components: 1) Continuous Glucose Monitoring (CGM) that includes the Guardian Link (3) Transmitter that is connected to the Guardian Sensor (3) to receive sensor glucose values at 5 minute intervals; 2) blood glucose meter (Roche Accu-Chek®) that will be used to calibrate the sensor and has the ability to send blood glucose values wirelessly as a convenience to the user; 3) MiniMedTM Clinical App to allow upload of data wirelessly, for sharing of glucose levels
To maintain the same functionality as the 670G 4.0 pump for the trial, we will not be using the MinimedTM Clinical App.
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Intervention code [1]
315657
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Prevention
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Intervention code [2]
315658
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Behaviour
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Intervention code [3]
315659
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Lifestyle
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Comparator / control treatment
Standard care for 6 months follow by an optional extension phase for another 6 months crossover to the intervention arm. Standard care is defined as the current treatment (insulin pump therapy with or without CGM) which the patient is on for at least six months and yet continues to have mean and recent HbA1c above 8.5%. Patients already on Medtronic 670G/780G hybrid closed loop system will not be eligible.
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Control group
Active
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Outcomes
Primary outcome [1]
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Glycaemic control as measured by HbA1c collected via blood test.
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Assessment method [1]
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Timepoint [1]
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At baseline and 6 months post randomisation.
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Secondary outcome [1]
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Changes in retinopathy scores from retinal photography.
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Assessment method [1]
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Timepoint [1]
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At randomisation
Endpoint - 6 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [2]
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Changes in retinal microvascular structure (arteriolar or venular dilation, increased vascular fractal dimension, branching and tortuosity) from retinal photography. This is a composite secondary outcome.
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Assessment method [2]
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Timepoint [2]
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At randomisation
Endpoint - 6 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [3]
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Health economic impact of the AHCL system vs standard therapy by collecting the following data during the study:
a) Calculate number of hypoglycaemic events
b) Changes in HbA1c
c) Amount of time spent by investigators with participants (training, education, support)
d) Calculating amount of diabetes management consumables used by participants (glucose strips, ketone strips, batteries, sensors, site dressings, lancets, needles, insulin)
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Assessment method [3]
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Timepoint [3]
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Baseline
At randomisation
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [4]
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Human factors: adherence patterns as measured by assessing AHCL system data upload completion.
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Assessment method [4]
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Timepoint [4]
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At randomisation
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [5]
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Psychosocial well-being measured via validated diabetes distress scales: Problem Areas in Diabetes questionnaires
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Assessment method [5]
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Timepoint [5]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [6]
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Psychosocial well-being measured via validated fear of hypoglycaemia scales: Hypoglycaemia Fear Survey II questionnaires
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Assessment method [6]
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Timepoint [6]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [7]
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Psychosocial well-being measured via validated general anxiety scales: Generalized Anxiety Disorder-7 and Patient Health Questionnaire-9 questionnaires
This is a composite secondary outcome.
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Assessment method [7]
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Timepoint [7]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [8]
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Psychosocial well-being measured via validated health status questionnaires: EQ-5D-Y
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Assessment method [8]
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Timepoint [8]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [9]
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Psychosocial well-being measured via validated diabetes-specific quality of life questionnaires: PedsQL
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Assessment method [9]
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Timepoint [9]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [10]
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Psychosocial well-being measured via validated treatment satisfaction questionnaires: INSPIRE and Diabetes Technology Questionnaires
This is a composite secondary outcome.
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Assessment method [10]
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Timepoint [10]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [11]
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Psychosocial well-being measured via validated hypoglycaemia awareness questionnaire: Gold Score Hypoglycaemic Awareness
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Assessment method [11]
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Timepoint [11]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [12]
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Glycaemic outcomes via CGM data for % CGM time <2.8 mmol/L
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Assessment method [12]
375864
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Timepoint [12]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [13]
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Glycaemic outcomes via CGM data for % CGM time <3.3 mmol/L
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Assessment method [13]
375865
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Timepoint [13]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [14]
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Glycaemic outcomes via CGM data for % CGM time <3.9 mmol/L
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Assessment method [14]
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Timepoint [14]
375866
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [15]
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Glycaemic outcomes via CGM data for % CGM time 3.9-7.8 mmol/L
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Assessment method [15]
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Timepoint [15]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [16]
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Glycaemic outcomes via CGM data for % CGM time 3.9-10.0mmol/L
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Assessment method [16]
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Timepoint [16]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [17]
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Glycaemic outcomes via CGM data for % CGM time >10.0 mmol/L
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Assessment method [17]
375869
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Timepoint [17]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [18]
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Glycaemic outcomes via CGM data for % CGM time >13.9 mmol/L
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Assessment method [18]
375870
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Timepoint [18]
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [19]
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Glycaemic outcomes via CGM data for % CGM time >16.7 mmol/L
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Assessment method [19]
375871
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Timepoint [19]
375871
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Secondary outcome [20]
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Glycaemic outcomes using Standard Deviation and Coefficient of Variation of CGM values
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Assessment method [20]
375872
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Timepoint [20]
375872
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Baseline
Midpoint - 3 months post-baseline
Endpoint - 6 months post-baseline
Midpoint optional extension phase - 9 months post-baseline
Endpoint optional extension phase - 12 months post-baseline
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Eligibility
Key inclusion criteria
1. Type 1 diabetes (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus, diagnosed at least 1 year ago)
2. Fasting C peptide <0.1nmol/L (in the absence of hypoglycaemia)
3. Pump therapy for at least 6 months
4. Age 12 to 25 years
5. Recent HbA1c above 8.5% in the last 3 months
6. Mean HbA1c above 8.5% for 6 months
7. Willing to follow study instructions
8. Willing to perform at least 3 finger stick blood glucose measurements daily
9. Willing to perform required sensor calibrations
10. Capable of reading and understand instructions in English
11. Living in an area with internet and cellular phone coverage
12. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
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Minimum age
12
Years
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Maximum age
25
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Severe DKA in the 6 months prior to the screening visit
2. Use of any non-insulin glucose-lowering agent within the past 3 months
3. Commenced CGM in the 3 months prior to the screening visit
4. Pregnancy or planned pregnancy within the study period
5. Uncontrolled coeliac disease (not following a gluten free diet), or other untreated malabsorption
6. Uncontrolled thyroid disease
7. Clinically-significant gastroparesis
8. Poor visual acuity precluding use of the investigational technology
9. Inability or unwillingness to meet protocol requirements
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Dynamic (adaptive) random allocation methods - minimisation
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
The power calculation is for a parallel study design with two groups of equal size. Based on information in the WA population based database and current data (de Bock et al, accepted JDST 2018), we expect a between group difference of 1.5% in HbA1c at 6 months with a SD of 1.7% for both groups. With alpha set at 0.05, 22 subjects would be required in each group to have 80% power to detect a difference of 1.5%. It is assumed the total dropout rate will be up to 15%, so we plan to recruit 50 subjects in total.
The primary analysis will assess differences in HbA1c (%) with AHCL versus standard therapy, measured six months post-randomisation using analysis of covariance (ANCOVA) with adjustment for baseline HbA1c. Least square means and least square mean differences and their associated 95% confidence intervals will be presented for each treatment group and between groups.
Model residuals will be used to assess model fit. If the residuals indicate poor model fit, the outcome variable will be transformed and the model refitted and evaluated. If poor model fit cannot be addressed, nonparametric analysis will be performed. In the event that residuals are not normally distributed: the Mann–Whitney–Wilcoxon (Wilcoxon Rank-Sum) Test will be employed if raw data are symmetric; if raw data are non-symmetric, bootstrap methods will be used to test the difference between groups.
Continuous secondary outcomes (glycaemic, auxological, clinical, psychosocial) will be analysed using the ANCOVA approach described above.
Secondary analysis for outcomes collected at multiple time points will be conducted using linear mixed models including random effects and various variance-covariance structures to account for non-independence. Akaike information criterion (AIC) will be used to determine the most appropriate model.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
31/01/2020
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Actual
25/06/2020
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Date of last participant enrolment
Anticipated
1/07/2022
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Actual
15/07/2022
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Date of last data collection
Anticipated
28/09/2023
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Actual
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Sample size
Target
50
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Accrual to date
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Final
46
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Recruitment in Australia
Recruitment state(s)
NSW,SA,WA,VIC
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Recruitment hospital [1]
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Perth Children's Hospital - Nedlands
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Recruitment hospital [2]
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The Royal Childrens Hospital - Parkville
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Recruitment hospital [3]
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Womens and Childrens Hospital - North Adelaide
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Recruitment hospital [4]
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The Children's Hospital at Westmead - Westmead
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Recruitment postcode(s) [1]
28120
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6009 - Nedlands
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Recruitment postcode(s) [2]
28121
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3052 - Parkville
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Recruitment postcode(s) [3]
28122
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5006 - North Adelaide
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Recruitment postcode(s) [4]
28123
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2145 - Westmead
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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JDRF Australia
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Address [1]
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Level 4, 80 Chandos Street
St Leonards NSW 2065
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Country [1]
303914
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Australia
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Primary sponsor type
Other Collaborative groups
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Name
Telethon Kids Institute
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Address
Perth Children's Hospital
15 Hospital Avenue
Nedlands 6009 WA
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
304066
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Child and Adolescent Health Service HREC
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Ethics committee address [1]
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Perth Children’s Hospital
15 Hospital Avenue
Nedlands WA 6009
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
304418
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Approval date [1]
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09/05/2018
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Ethics approval number [1]
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RGS0000000886
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Summary
Brief summary
This is a 6 month multi-centre randomized controlled trial assessing the effect of advanced hybrid closed loop (AHCL) in adolescents with poor glycaemic control and comparing this technology with their standard care. The purpose of this project is to utilize an automated insulin delivery system to improve glycaemic control which has been shown during in-home use by adolescents and adults with increased time in target, and reductions in HbA1c, hyperglycaemia and hypoglycaemia, compared to baseline. Hence, it would be valuable to test the effectiveness of AHCL in patients with poor glycaemic control.
We hypothesize that AHCL system will circumvent the significant glycaemic excursion associated with conventional therapy in patients with poor glycaemic control. Reduced adherence to diabetes self-management tasks is often associated with poor glycaemic control and this trial will address, in effect, whether the challenge of managing AHCL is less than the challenge of routine treatment and will generate data that will inform approaches to enhance adherence.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Timothy W Jones
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Address
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Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
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Australia
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Phone
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+61 864562222
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Fax
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Email
96886
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[email protected]
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Contact person for public queries
Name
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Miss Julie Dart
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Address
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Telethon Kid's Institute
Northern Entrance
Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
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Australia
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Phone
96887
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+61 864564608
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Fax
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Email
96887
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[email protected]
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Contact person for scientific queries
Name
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Dr Mary Abraham
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Address
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Perth Children's Hospital
15 Hospital Avenue
Nedlands WA 6009
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Country
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Australia
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Phone
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+61 864565027
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Fax
96888
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All de-identified data will be shared as per contract with funding body JDRF as well as sponsoring institution's regulation and policies according to GCP.
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When will data be available (start and end dates)?
At completion of the study and publications of primary and secondary outcomes - tentative after Dec 2022 and up to 15 years thereafter.
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Available to whom?
Investigators external to the trial will need to submit an application to request for participant data. Guidelines for application will be made available closer to study completion.
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Available for what types of analyses?
Translational analyses with proven scientific and ethical rigor identified through the application process.
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How or where can data be obtained?
Please submit a data request application to Children's Diabetes Centre at Telethon Kids Institute via email
[email protected]
. Guidelines for application will be made available closer to study completion.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5076
Study protocol
[email protected]
378457-(Uploaded-01-09-2023-16-22-23)-Study-related document.pdf
5077
Ethical approval
[email protected]
20521
Ethical approval
378457-(Uploaded-01-09-2023-16-24-37)-Study-related document.pdf
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.
Download to PDF