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Trial registered on ANZCTR


Registration number
ACTRN12617000520336
Ethics application status
Approved
Date submitted
29/03/2017
Date registered
10/04/2017
Date last updated
21/04/2021
Date data sharing statement initially provided
28/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigation of an artificial pancreas for adults with type 1 diabetes
Scientific title
Evaluation of the efficacy and cost-effectiveness of long-term hybrid closed-loop insulin delivery in improving glycaemia, psychological wellbeing, sleep quality, cognition, and biochemical markers of vascular risk in adults with type 1 diabetes compared with standard care
Secondary ID [1] 291518 0
Nil known
Universal Trial Number (UTN)
U1111-1194-6526
Trial acronym
HCL-Adult
Linked study record
Nil

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes mellitus 302605 0
Condition category
Condition code
Metabolic and Endocrine 302127 302127 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a hybrid closed-loop (HCL) automated insulin delivery system. 

This randomised, controlled study compares the efficacy of insulin delivered via the HCL system versus standard insulin therapy for 26 weeks. The HCL system comprises a glucose sensor coupled with an insulin pump containing a computerised automated insulin delivery algorithm. Glucose sensor information is transmitted to the insulin pump, and the dose of insulin is calculated by the algorithm and delivered every 5 min to account for basal insulin requirements. Participant initiated bolus insulin doses are still required for meals. 

Participants recruited from seven clinical sites in Australia will undertake a 5-9 week run-in period, during which time they will receive carbohydrate-counting education provided by a dietician and will be taught how to adjust their rapid-acting insulin administered with meals accordingly. This will be an individualised one-on-one education program, tailored to each participant’s prior knowledge. Each education session will take approximately 30–60 min, and up to 4 sessions will be scheduled over the subsequent 2-3 weeks until the participant’s carbohydrate-counting ability is deemed proficient by a study dietician. Other study data collected includes masked continuous glucose monitoring (CGM), psychological and cognitive measures, sleep quality, cardiac rhythm, and biochemical markers of vascular risk. 

Following run-in, participants will be randomised 1:1 to intervention or control. Participants in the intervention group will transition from their usual insulin delivery regimen to HCL, with close supervision by study doctors and nurses. These participants will use the HCL system until 26 weeks post-randomisation, following which they will transfer back to their usual diabetes management.

The participants randomised to intervention will receive detailed individualised education and training regarding use of the HCL system over a 2–5 week period following randomisation. This will include programming and operation of the HCL system, basal and bolus insulin delivery, set up of the reservoir and infusion set, insulin delivery line insertion and change, sensor insertion and change, and sick day management. This education specific to the HCL system will be provided face-to-face by a diabetes nurse educator over 2-4 individual educational sessions, each 1–4 hours in duration, tailored to each participant’s prior knowledge. Participants will also be provided educational material and resources, including a user guide booklet for the investigational HCL system, and will receive regular phone contact between study visits from a diabetes nurse educator to support their transition to the HCL system. Participants will upload their pump weekly for review.

Two sub-studies will be performed within the main study. The first sub-study will involve a sub-group of participants with refractory hypoglycaemia and impaired hypoglycaemia awareness. Changes in counter-regulatory hormonal responses assessed via hypoglycaemic clamp studies, and changes in hypoglycaemia awareness and glycaemic control, will be compared during HCL vs. standard therapy. A total of 10 participants will be enrolled in this sub-study to be conducted at two sites that specialise in islet cell transplantation. These participants need to meet the additional criteria of refractory hypoglycaemia and impaired hypoglycaemia awareness. The hypoglycaemic clamp studies will be conducted in hospital clinical trial centres, under direct supervision of study doctors, at two additional time points during the study (mid-study at ~11-13 weeks post-randomisation, and end-of-study at 26 weeks post-randomisation). An insulin infusion will be started at 1.0 mU/kg/min for 270 min. Subsequently, a variable rate of 25% glucose intravenous infusion will be initiated to achieve 45 min of plasma glucose plateaus at 4.4 mmol/L, 3.6 mmol/L and 2.5 mmol/L, sequentially. Venous glucose measurements will be taken every 5 min to adjust the glucose infusion rate. Additional venous samples will be collected every 30 min for analyses. 

The second sub-study will compare metabolic control with two different types of exercise on a stationary bicycle in the intervention vs control groups. Each participant will undertake both exercise protocols (moderate-intensity and high-intensity interval exercise) in random order. The washout period between exercise sessions will be ~7 days. The high-intensity interval exercise protocol involves high-intensity interval training to simulate strenuous team sport activities: 5 min warm-up at 25% VO2max, then six repetitions each of 4 min cycling at an intensity halfway between anaerobic threshold (calculated for each participant) and maximal intensity (100% VO2max) which corresponds to approximately 70% VO2max, followed by 2 min complete rest. An additional 4 min rest will be provided between the third and fourth repetitions. The moderate-intensity exercise protocol involves steady-state exercise to simulate undertaking a run or bicycle ride: 5 min warm-up at 25% VO2max, followed by 40 min steady-state cycling up to 70% of anaerobic threshold which corresponds to approximately 45% VO2max. For the exercise sub-study, we aim to recruit 20 participants (10 in each study arm).
Intervention code [1] 297591 0
Treatment: Devices
Intervention code [2] 297663 0
Treatment: Drugs
Comparator / control treatment
Standard therapy involves continuation of participants' usual manual insulin delivery regimen (via either injections or pump) without adjunct continuous glucose sensing.
Control group
Active

Outcomes
Primary outcome [1] 301561 0
Percent of time CGM sensor glucose is in target range (3.9-10 mmol/L) during HCL vs standard therapy.
Timepoint [1] 301561 0
End-of-study (23 - 26 weeks post-randomisation)
Secondary outcome [1] 333025 0
Glycaemic outcomes during HCL vs standard therapy:
CGM metrics for day [06:00–00:00], night [00:00–06:00] and day+night, measured at mid-study, end-of-study, and mid+end-of-study combined:
1.1. % CGM time 3.9–10mmol/L (excluding the primary endpoint)
1.2. % CGM time <2.8 mmol/L
1.3. % CGM time <3.3 mmol/L
1.4. % CGM time <3.9 mmol/L
1.5. % CGM time 3.9–7.8 mmol/L
1.6. % CGM time >10.0 mmol/L
1.7. % CGM time >13.9 mmol/L
1.8. % CGM time >16.7 mmol/L
1.9. Measures of glycaemic variability including standard deviation and coefficient of variation of CGM values
1.10. Mean CGM glucose
Timepoint [1] 333025 0
Mid-study (11-13 weeks post-randomisation) and end-of-study (23-26 weeks post-randomisation)
Secondary outcome [2] 333026 0
Fasting capillary blood glucose during HCL vs standard therapy
Timepoint [2] 333026 0
During CGM period mid-study (11-13 weeks post-randomisation) and end-of-study (23-26 weeks post-randomisation)
Secondary outcome [3] 333027 0
HbA1c during HCL vs standard therapy measured on whole blood. All samples will be sent to a centralised DCCT-aligned laboratory.
Timepoint [3] 333027 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [4] 333028 0
1,5-anhydroglucitol on serum
Timepoint [4] 333028 0
26 weeks post-randomisation
Secondary outcome [5] 333029 0
Hospitalisations for diabetic ketoacidosis during HCL vs standard therapy, based on self-reporting by participants +/- review of medical records
Timepoint [5] 333029 0
From 0 to 26 weeks post-randomisation
Secondary outcome [6] 333030 0
Severe hypoglycaemia (defined as any low glucose level requiring the assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions) during HCL vs standard therapy
Timepoint [6] 333030 0
From 0 to 26 weeks post-randomisation
Secondary outcome [7] 333031 0
Symptomatic hypoglycaemia requiring carbohydrate rescue (with finger-prick glucose < 3.5 mmol/L) during HCL vs standard therapy
Timepoint [7] 333031 0
From 0 to 26 weeks post-randomisation
Secondary outcome [8] 333032 0
Change in total daily dose of insulin, insulin-to-carbohydrate ratio and basal/bolus proportions during HCL vs standard therapy, using participant records in a study logbook and pump uploads.
Timepoint [8] 333032 0
From 0 to 26 weeks post-randomisation
Secondary outcome [9] 333033 0
Change in body weight, assessed using digital scales, during HCL vs standard therapy
Timepoint [9] 333033 0
From 0 to 26 weeks post-randomisation
Secondary outcome [10] 333034 0
Psychological function assessing treatment satisfaction during HCL vs standard therapy, using The Diabetes Treatment Satisfaction Questionnaire (8 items - validated)
Timepoint [10] 333034 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [11] 333035 0
Psychological function assessing satisfaction with technology during HCL vs standard therapy, using the Diabetes Management Experiences Questionnaire (validated)
Timepoint [11] 333035 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [12] 333036 0
Psychological function assessing fear of hypoglycaemia during HCL vs standard therapy, using the Hypoglycaemia Fear Survey-II short form (11 items – validated)
Timepoint [12] 333036 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [13] 333039 0
Psychological function assessing fear of hyperglycaemia during HCL vs standard therapy, using the Hyperglycaemia Avoidance Scale (26 items - validated)
Timepoint [13] 333039 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [14] 333379 0
Psychological function assessing hypoglycaemia awareness during HCL vs standard therapy, using the Gold Score and Hypoglycaemia Awareness Scale of the HypoA-Q (validated)
Timepoint [14] 333379 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [15] 333380 0
Psychological function assessing diabetes distress during HCL vs standard therapy, using the Problem Areas in Diabetes Questionnaire (20 items - validated)
Timepoint [15] 333380 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [16] 333381 0
Psychological function assessing diabetes-specific quality of life during HCL vs standard therapy, using the DAWN impact of diabetes profile questionnaire (7 items - validated)
Timepoint [16] 333381 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [17] 333413 0
Psychological function assessing diabetes-specific positive well-being during HCL vs standard therapy, using the W-B Q28 subscale: DPosWB (4 items – validated)
Timepoint [17] 333413 0
13 weeks and 26 weeks post-randomisation
Secondary outcome [18] 333414 0
Psychological function assessing participants' expectations and experiences with the technology for the HCL study arm, using semi-structured psychological interviews
Timepoint [18] 333414 0
1 week, 13 weeks, 26 weeks and 39 weeks post-randomisation
Secondary outcome [19] 333415 0
Cognitive function during HCL vs standard therapy, using the Prospective-Retrospective Memory Questionnaire (16 items) and psychomotor vigilance task
Timepoint [19] 333415 0
Prospective-Retrospective Memory Questionnaire - 13 weeks and 26 weeks post-randomisation.
Psychomotor vigilance task - mid-study (11-12 weeks post-randomisation) and end-of-study (23-24 weeks post-randomisation)
Secondary outcome [20] 333450 0
Driving performance during HCL vs standard therapy, using a vehicle driving logger device
Timepoint [20] 333450 0
Mid-study (11 - 13 weeks post-randomisation) and end-of-study (23 - 26 weeks post-randomisation)
Secondary outcome [21] 333471 0
Sleep quality during HCL vs standard therapy, using actigraph device, Pittsburgh Sleep Quality Index, Karolinska Sleepiness Scale
Timepoint [21] 333471 0
Mid-study (11 - 13 weeks post-randomisation) and end-of-study (23 - 26 weeks post-randomisation)
Secondary outcome [22] 333484 0
Electrocardiograph profiles using Holter Monitors during HCL vs standard therapy, using corrected QT interval (QTc); heart rate; cardiac arrhythmias as a composite outcome
Timepoint [22] 333484 0
Mid-study (11-12 weeks post-randomisation) and end-of-study (23-24 weeks post-randomisation)
Secondary outcome [23] 333485 0
Health-economic impact of HCL vs standard therapy using data derived from: 
QALYs; hypoglycaemic events and HbA1c; participant and family reporting on work interruption; reported time spent on training, education and support, by the type of health professional resource used; diabetes management consumables; administrative linked data from the Medicare Benefits Schedule (MBS) and Pharmaceutical Benefits Scheme (PBS) to track resource utilisation
Timepoint [23] 333485 0
From 0 to 26 weeks post-randomisation
Secondary outcome [24] 333486 0
Biochemical markers of vascular risk (blood and urine samples) during HCL vs standard therapy - including cell adhesion molecules (CAMS); oxidized low density lipoprotein; myeloperoxidase; microRNA signatures for arterial, renal and retinal complications; telomerase; DNA methylation/acetylation; isoprostanes (blood and urine) and proteomics; clotting profile
Timepoint [24] 333486 0
26 weeks post-randomisation
Secondary outcome [25] 333487 0
HCL system performance using the following measures - % time hybrid closed loop is active; unplanned exits from closed loop (n); sensor performance – mean absolute relative difference (MARD), sensor failures (n); insulin delivery line performance – reported delivery line failures (n); calls to technical help-line (n)
Timepoint [25] 333487 0
From 0 to 26 weeks post-randomisation
Secondary outcome [26] 333488 0
Human-technology interaction for the HCL study arm using questions designed specifically for the study which were formulated to elicit the individual's perception of the HCL system. Participants will receive two questions per week via short message service (SMS) which have an estimated response time of <30 seconds
Timepoint [26] 333488 0
From 0 to 26 weeks post-randomisation
Secondary outcome [27] 333489 0
(Sub-study 1): Changes in hypoglycaemia awareness during HCL vs standard therapy, using the Clarke and Edmonton Hypoglycaemia Questionnaire
Timepoint [27] 333489 0
Mid-study (11-13 weeks post-randomisation) and end-of-study (26 weeks post-randomisation)
Secondary outcome [28] 333643 0
(Sub-study 1): Change in counter-regulatory hormone responses during HCL vs standard therapy, using serum assays
Timepoint [28] 333643 0
End-of-study (26 weeks post-randomisation)
Secondary outcome [29] 333644 0
(Sub-study 1): Changes in glycaemic outcome during HCL vs standard therapy, using CGM metrics
Timepoint [29] 333644 0
Mid-study (11-13 weeks post-randomisation) and end-of-study (23-26 weeks post-randomisation)
Secondary outcome [30] 333645 0
(Sub-study 2 Primary Outcome) Percent CGM time spent in target glycaemia (3.9–10 mmol/L) for twenty-four hours following exercise commencement during HCL vs standard therapy
Timepoint [30] 333645 0
0-24 hours post exercise commencement
Secondary outcome [31] 333646 0
(Sub-study 2 Secondary Outcome): Glycaemic outcomes 24 hours post exercise commencement, during HCL vs standard therapy:
1.1. % CGM time 3.9–10mmol/L (excluding the primary endpoint)
1.2. % CGM time <2.8 mmol/L
1.3. % CGM time <3.3 mmol/L
1.4. % CGM time <3.9 mmol/L
1.5. % CGM time 3.9–7.8 mmol/L
1.6. % CGM time >10.0 mmol/L
1.7. % CGM time >13.9 mmol/L
1.8. % CGM time >16.7 mmol/L
1.9 Glycaemia Variability as determined by mean amplitude of glycaemic excursions (MAGE) and standard deviation
1.10 CGM AUC > 10.0 mmol/L
1.11 CGM AUC <4.0 mmol/L
Timepoint [31] 333646 0
0-24 hours post exercise commencement
Secondary outcome [32] 333647 0
(Sub-study 2 Secondary Outcome): Glycaemic outcomes for the night following exercise [0:00-06:00] during HCL vs standard therapy:

1.1. % CGM time 3.9–10mmol/L (excluding the primary endpoint)
1.2. % CGM time <2.8 mmol/L
1.3. % CGM time <3.3 mmol/L
1.4. % CGM time <3.9 mmol/L
1.5. % CGM time 3.9–7.8 mmol/L
1.6. % CGM time >10.0 mmol/L
1.7. % CGM time >13.9 mmol/L
1.8. % CGM time >16.7 mmol/L
1.9 Glycaemia Variability as determined by mean amplitude of glycaemic excursions (MAGE) and standard deviation
1.10 CGM AUC > 10.0 mmol/L
1.11 CGM AUC <4.0 mmol/L
Timepoint [32] 333647 0
Night following exercise completion [0:00-0:06:00]
Secondary outcome [33] 333648 0
(Sub-study 2 Secondary Outcome): Glycaemic outcomes from time of exercise commencement until 2 hours post-exercise completion during HCL vs standard therapy:
1.1. % CGM time 3.9–10mmol/L 
1.2. % CGM time <2.8 mmol/L
1.3. % CGM time <3.3 mmol/L
1.4. % CGM time <3.9 mmol/L
1.5. % CGM time 3.9–7.8 mmol/L
1.6. % CGM time >10.0 mmol/L
1.7. % CGM time >13.9 mmol/L
1.8. % CGM time >16.7 mmol/L
1.9 Glycaemia Variability as determined by mean amplitude of glycaemic excursions (MAGE) and standard deviation
1.10 CGM AUC >10.0 mmol/L
1.11 CGM AUC <4.0 mmol/L
Timepoint [33] 333648 0
From time of exercise commencement until 2 hours post-exercise completion
Secondary outcome [34] 333649 0
(Sub-study 2 Secondary Outcome): Difference in peak counter-regulatory hormone levels measured using serum assays for adrenaline, noradrenaline, dopamine, glucagon, growth hormone and cortisol during HCL vs standard therapy for:
1. High-intensity interval exercise
2. Moderate-intensity exercise
Timepoint [34] 333649 0
From time of exercise commencement until 2 hours post-exercise completion
Secondary outcome [35] 333650 0
(Sub-study 2 Secondary Outcome): Episodes of hypoglycaemia during HCL vs standard therapy confirmed by capillary blood with the study glucose meter
1. Any episode (n) of blood glucose < 3.9 mmol/L for 0-24 hours following exercise commencement. 
2. Episodes of major hypoglycaemia i.e. requiring 3rd party assistance (n) for 0-24 hours following exercise commencement.
Timepoint [35] 333650 0
0-24 hours post exercise commencement
Secondary outcome [36] 333651 0
(Sub-study 2 Secondary Outcome): Episodes of hyperglycaemia (>10.0 mmol/L) and blood ketones >0.4 mmol/L (n) following exercise commencement during HCL vs standard therapy, using CGM data and finger prick blood ketone testing
Timepoint [36] 333651 0
0-24 hours post exercise commencement
Secondary outcome [37] 333652 0
(Sub-study 2 Secondary Outcome): Sensor MARD during exercise, compared with reference YSI venous blood glucose measurements
Timepoint [37] 333652 0
During 45 min of exercise

Eligibility
Key inclusion criteria
1. Type 1 diabetes 
2. Insulin delivered via either multiple daily (basal and bolus) injections, or via insulin pump (for at least 3 months)
3. HbA1c <= 10.5%
Minimum age
25 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Chronic kidney disease (eGFR <45mL/min/1.73m2)
2. Current use of real-time CGM
3. Use of non-insulin glucose-lowering agent in the past 3 months
4. Steroid use (oral or injected) within past 3 months
5. Pregnancy

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)
Allocation will be concealed from participants and site investigators during enrolment and study run-in, until the time of randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central computerised randomisation, using minimisation method with three stratification variables (study site, baseline insulin delivery modality, and baseline percent time-in-target glycaemic range as determined by masked CGM)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The power calculation is for a parallel study design with two groups of equal size. It is based on standard deviations (SDs) of the percentage time-in-target glucose range at 6 months (adjusted for baseline) observed for the subset of participants in two randomised clinical trials from the JDRF Study Group who had similar characteristics to participants being recruited here. The SD (95% confidence interval) for pump users was 9% (8%, 12%) and for insulin injection users was 10% (7%, 19%).

From an initial overall sample size of 120, with a dropout rate of 10%, a common SD of 9% and a type I error rate of 5%, the power to detect a minimum absolute difference of 5% time-in-target glucose range would be 80%. A more conservative scenario with a dropout rate of 20%, and unequal SDs of 12% and 19% for pump and insulin injection users, respectively, increases the minimum detectable absolute difference to 9% with power of 80%.

The primary analysis will assess differences in the proportion of time-in-target glucose sensor range (3.9–10.0 mmol/L) with HCL versus standard therapy, measured by masked CGM at 23–26 weeks post-randomisation on an intention-to-treat basis using ANCOVA with adjustment for baseline time-in-target range. A p-value threshold of <0.05 will be used to declare statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2017
Actual
26/04/2017
Date of last participant enrolment
Anticipated
5/03/2018
Actual
24/01/2019
Date of last data collection
Anticipated
30/10/2019
Actual
31/10/2019
Sample size
Target
120
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS,WA,VIC
Recruitment hospital [1] 7719 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 7720 0
The Alfred - Prahran
Recruitment hospital [3] 7721 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 7722 0
Westmead Hospital - Westmead
Recruitment hospital [5] 7723 0
Repatriation Hospital - Daw Park
Recruitment hospital [6] 7724 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [7] 7725 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 15642 0
3065 - Fitzroy
Recruitment postcode(s) [2] 15643 0
3004 - Prahran
Recruitment postcode(s) [3] 15644 0
3050 - Parkville
Recruitment postcode(s) [4] 15645 0
2145 - Westmead
Recruitment postcode(s) [5] 15646 0
5041 - Daw Park
Recruitment postcode(s) [6] 15647 0
6009 - Nedlands
Recruitment postcode(s) [7] 15648 0
7000 - Hobart

Funding & Sponsors
Funding source category [1] 296008 0
Charities/Societies/Foundations
Name [1] 296008 0
JDRF Australia T1DCRN
Country [1] 296008 0
Australia
Funding source category [2] 296066 0
Government body
Name [2] 296066 0
National Health and Medical Research Council (NHMRC)
Country [2] 296066 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Grattan Street, Parkville Victoria 3010
Country
Australia
Secondary sponsor category [1] 294934 0
None
Name [1] 294934 0
Address [1] 294934 0
Country [1] 294934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297269 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 297269 0
41 Victoria Parade
Fitzroy VIC 3065
Ethics committee country [1] 297269 0
Australia
Date submitted for ethics approval [1] 297269 0
15/06/2016
Approval date [1] 297269 0
24/06/2016
Ethics approval number [1] 297269 0
HREC-D 088/16

Summary
Brief summary
A ‘hybrid closed-loop (HCL)’ system or ‘hybrid artificial pancreas’ provides automated control of basal insulin delivery, with ongoing requirements for manual boluses of insulin for meals. These systems offer the potential to reduce significant glycaemic excursions outside of a healthy glucose range compared with standard therapy. Small, short-term pilot studies have shown superior glucose control and lower rates of hypoglycaemia with use of a hybrid artificial pancreas compared with manual insulin delivery. Closed-loop insulin delivery has the potential to revolutionise type 1 diabetes therapy.

The primary study rationale is to fill a knowledge gap regarding the efficacy of glucose control with long-term use of an HCL system vs standard manual insulin therapy, including % time in target glucose range, as well as glucose excursions (both hypoglycaemia and hyperglycaemia). This study will explore the impact of the HCL system on fear of hypoglycaemia, treatment satisfaction, psychological outcomes, sleep quality and cardiac rhythm, and the economic impact of using HCL. Any improvement in glycaemia may also be reflected in biomarkers associated with the risk for long-term complications of diabetes.

One sub-study will explore the efficacy of the HCL system vs. standard therapy in regards to hypoglycaemia awareness and the counter-regulatory hormone response to hypoglycaemia of participants with severe hypoglycaemia and impaired hypoglycaemia awareness. A second sub-study will compare glucose control with different types of exercise using the HCL system vs. standard therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73526 0
A/Prof David Norman O'Neal
Address 73526 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065
Country 73526 0
Australia
Phone 73526 0
+61 3 9231 2211
Fax 73526 0
Email 73526 0
[email protected]
Contact person for public queries
Name 73527 0
Melissa Lee
Address 73527 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065
Country 73527 0
Australia
Phone 73527 0
+61 3 9231 2211
Fax 73527 0
Email 73527 0
[email protected]
Contact person for scientific queries
Name 73528 0
Sybil McAuley
Address 73528 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy
VIC 3065
Country 73528 0
Australia
Phone 73528 0
+61 3 9231 2211
Fax 73528 0
Email 73528 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5476Study protocol    372617-(Uploaded-28-10-2019-12-01-28)-Study-related document.pdf
5477Statistical analysis plan    372617-(Uploaded-28-10-2019-11-59-34)-Study-related document.pdf
5478Study protocol https://bmjopen.bmj.com/content/8/6/e020274.long 



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of 6 months of hybrid closed-loop insulin delivery in adults with type 1 diabetes: A randomised controlled trial protocol.2018https://dx.doi.org/10.1136/bmjopen-2017-020274
EmbaseSix months of hybrid closed-loop versus manual insulin delivery with fingerprick blood glucose monitoring in adults with type 1 diabetes: A randomizedcontrolled trial.2020https://dx.doi.org/10.2337/dc20-1447
EmbaseLess Nocturnal Hypoglycemia but Equivalent Time in Range among Adults with Type 1 Diabetes Using Insulin Pumps Versus Multiple Daily Injections.2021https://dx.doi.org/10.1089/dia.2020.0589
EmbaseDriving with Type 1 Diabetes: Real-World Evidence to Support Starting Glucose Level and Frequency of Monitoring During Journeys.2022https://dx.doi.org/10.1089/dia.2021.0460
EmbaseAn Assessment of Clinical Continuous Glucose Monitoring Targets for Older and High-Risk People Living with Type 1 Diabetes.2023https://dx.doi.org/10.1089/dia.2022.0350
N.B. These documents automatically identified may not have been verified by the study sponsor.