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Trial registered on ANZCTR
Registration number
ACTRN12619000515190
Ethics application status
Approved
Date submitted
20/03/2019
Date registered
1/04/2019
Date last updated
2/02/2021
Date data sharing statement initially provided
1/04/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
Older Adult Closed Loop (ORACL) Study for Type 1 Diabetes
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Scientific title
Older Adult Closed Loop (ORACL) Study for Glucose Management in Type 1 Diabetes
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Secondary ID [1]
297658
0
None
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Universal Trial Number (UTN)
U1111-1229-7168
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Trial acronym
ORACL
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Linked study record
N/A
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Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes
311935
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Condition category
Condition code
Metabolic and Endocrine
310518
310518
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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 randomised crossover study compares closed-loop (CL) therapy versus open-loop (OL) therapy (with insulin pump and real-time continuous glucose monitoring (CGM)) for older adults with type 1 diabetes.
This study will consist of 12 visits over approximately 9-11 months. Duration of visits will be up to 6 hours to provide participant education and collect study outcome data. All procedures involving study participants will be undertaken by study doctors, research nurses, dietitians and psychologists. Participants will be provided with study devices and will receive face-to-face education regarding their use. Clinician researchers will determine when educational requirements have been completed. The study intervention is an insulin delivery system, that has CL capability to continuously deliver automated subcutaneous insulin doses via a cannula placed transcutaneously. The CL system comprises a CGM device (with transcutaneous glucose sensor filament connected to an external recorder), 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 automatically delivered every 5 minutes to account for basal insulin requirements. User-initiated bolus insulin doses are required for meals. Intervention adherence and function will be assessed via pump upload.
The study involves a run-in period for education and collection of pre-randomisation data (up to 10 weeks depending on individual participant educational requirements), pre-randomisation measures (2 weeks), randomisation, followed by two 4-month study stages undertaken in random order. The stages are (i) CL with automated basal insulin delivery, and (ii) OL with manual insulin delivery via pump and real-time CGM. There will no wash-out period between stages.
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Intervention code [1]
313891
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Treatment: Devices
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Comparator / control treatment
OL stage - CGM plus manual determination of subcutaneous insulin doses continuously delivered via insulin pump as per the individual's usual clinical care.
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of time spent with sensor glucose 3.9–10.0 mmol/L
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Assessment method [1]
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Timepoint [1]
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Final 3 months of each study stage
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Secondary outcome [1]
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Proportion of time spent with sensor glucose 3.9–10.0 mmol/L
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Assessment method [1]
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Timepoint [1]
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Final 3 months of each study stage for:
1) day [06:00-23:59]
2) night [00:00-05:59]
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Secondary outcome [2]
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Proportion of time spent with sensor glucose <3.0 mmol/L
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Assessment method [2]
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Timepoint [2]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [3]
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Proportion of time spent with sensor glucose <3.3 mmol/L
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Assessment method [3]
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Timepoint [3]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [4]
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Proportion of time spent with sensor glucose <3.9 mmol/L
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Assessment method [4]
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Timepoint [4]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [5]
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Proportion of time spent with sensor glucose 3.9–7.8 mmol/L
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Assessment method [5]
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Timepoint [5]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [6]
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Proportion of time spent with sensor glucose >10.0 mmol/L
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Assessment method [6]
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Timepoint [6]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [7]
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Proportion of time spent with sensor glucose >13.9 mmol/L
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Assessment method [7]
367936
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Timepoint [7]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [8]
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Proportion of time spent with sensor glucose >16.7 mmol/L
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Assessment method [8]
367937
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Timepoint [8]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [9]
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Mean CGM glucose
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Assessment method [9]
367938
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Timepoint [9]
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [10]
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CGM glucose variability (standard deviation, coefficient of variation)
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Assessment method [10]
367939
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Timepoint [10]
367939
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Final 3 months of each study stage for:
1) 24 h/day
2) day [06:00-23:59]
3) night [00:00-05:59]
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Secondary outcome [11]
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HbA1c (samples tested at a centralised DCCT-aligned laboratory).
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Assessment method [11]
367940
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Timepoint [11]
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [12]
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Functional ability assessed by Katz ADLs and Lawton-Brody Instrumental ADLs questionnaires
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Assessment method [12]
367941
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Timepoint [12]
367941
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [13]
367942
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Frailty assessed by physical testing and FRAIL, MNA and Sarcopenia SARC-F questionnaires
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Assessment method [13]
367942
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Timepoint [13]
367942
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [14]
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Diabetes-related ambulance attendances (by study-specific questionnaire)
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Assessment method [14]
367943
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Timepoint [14]
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From randomisation to end of Study Stage 2
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Secondary outcome [15]
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Diabetes-related hospitalisations (by study-specific questionnaire then verified via hospital records)
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Assessment method [15]
367944
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Timepoint [15]
367944
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From randomisation to end of Study Stage 2
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Secondary outcome [16]
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Incident falls (by study-specific questionnaire)
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Assessment method [16]
367945
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Timepoint [16]
367945
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From randomisation to end of Study Stage 2
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Secondary outcome [17]
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Incident delirium (by study-specific questionnaire then verified via medical records)
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Assessment method [17]
367946
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Timepoint [17]
367946
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From randomisation to end of Study Stage 2
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Secondary outcome [18]
367947
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Incident pressure sores (by study-specific questionnaire)
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Assessment method [18]
367947
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Timepoint [18]
367947
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From randomisation to end of Study Stage 2
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Secondary outcome [19]
367948
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Incident infections (by study-specific questionnaire)
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Assessment method [19]
367948
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Timepoint [19]
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From randomisation to end of Study Stage 2
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Secondary outcome [20]
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Episodes of severe hypoglycaemia (by study-specific questionnaire)
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Assessment method [20]
367949
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Timepoint [20]
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From randomisation to end of Study Stage 2
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Secondary outcome [21]
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Episodes of diabetic ketoacidosis (by study-specific questionnaire then verified by medical records)
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Assessment method [21]
367950
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Timepoint [21]
367950
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From randomisation to end of Study Stage 2
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Secondary outcome [22]
367951
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Total daily dose of insulin (from insulin pump data)
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Assessment method [22]
367951
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Timepoint [22]
367951
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Final 3 months of each study stage
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Secondary outcome [23]
367952
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Cognitive functioning via MOCA, MMSE, NART, Trails Making Tasks B, SDMT and Grooved Pegboard
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Assessment method [23]
367952
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Timepoint [23]
367952
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [24]
367953
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Psychosocial well-being via INSPIRE, HFS-II, Gold and Clarke scores, PAID-5, GDS, DIDP and semi-structured interviews
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Assessment method [24]
367953
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Timepoint [24]
367953
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [25]
367954
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CGM glucose patterns while driving (using a vehicle driving logger device)
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Assessment method [25]
367954
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Timepoint [25]
367954
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Final 3 months of each study stage
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Secondary outcome [26]
367955
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Sleep quality via PSQI and actigraphy data
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Assessment method [26]
367955
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Timepoint [26]
367955
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1) End of Study Stage 1
2) End of Study Stage 2
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Secondary outcome [27]
367956
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Electrocardiograph (ECG) profile
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Assessment method [27]
367956
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Timepoint [27]
367956
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1) End of Study Stage 1
2) End of Study Stage 2
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Eligibility
Key inclusion criteria
1) Type 1 diabetes of >=10 years duration
2) Using insulin pump therapy (>=1 year pump experience) with established pump settings
3) HbA1c <=10.5%
4) Able to use study devices (with or without caregiver assistance)
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Minimum age
60
Years
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Maximum age
No limit
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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) Non-type 1 diabetes
2) Use of closed-loop insulin delivery within past 3 months
3) Nephropathy with eGFR <30 mL/min/1.73m^2 or on dialysis
4) Use of any glucose-lowering agent other than insulin within past 3 months
5) Corticosteroid medication within past 3 months (or anticipated during the study period)
6) Inability to tolerate skin adhesives
7) History of myocardial infarction, severe uncontrolled heart failure, unstable angina, transient ischaemic attack, stroke, or thromboembolic disease in past 3 months
8) Clinical diagnosis of moderate or severe dementia
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Study design
Purpose of the study
Treatment
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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)
Randomisation will be delivered via computer program. This information will not be available to research site personnel or participants until time of randomisation.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a central computer. The order of study stages will be randomly assigned, stratified according to study site, using block randomisation with random permuted blocks.
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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
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Analyses will be on an intention-to-treat basis. We will test for period and carry-over effects. Should no bias from period and carry-over effects be statistically significant, paired t-tests will be used to assess the significance of time-in-target range between CL versus OL. However, should there be period and/or carry-over effects, mixed effects modelling will be employed. No adjustment for multiplicity is planned. No interim analysis is planned.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
4/04/2019
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Actual
4/04/2019
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Date of last participant enrolment
Anticipated
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Actual
24/02/2020
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Date of last data collection
Anticipated
20/12/2020
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Actual
21/12/2020
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Sample size
Target
30
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Accrual to date
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Final
30
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
13330
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment hospital [2]
13331
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment postcode(s) [1]
25931
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3065 - Fitzroy
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Recruitment postcode(s) [2]
25932
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3050 - Parkville
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Funding & Sponsors
Funding source category [1]
302189
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Charities/Societies/Foundations
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Name [1]
302189
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JDRF
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Address [1]
302189
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26 Broadway, New York, NY 10004
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Country [1]
302189
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United States of America
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Funding source category [2]
302292
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Charities/Societies/Foundations
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Name [2]
302292
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Diabetes Australia
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Address [2]
302292
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101 Northbourne Ave
Turner ACT 2612
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Country [2]
302292
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Australia
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Primary sponsor type
Hospital
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Name
St Vincent's Hospital Melbourne
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Address
27 Victoria Pde
Fitzroy, VIC 3065
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Country
Australia
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Secondary sponsor category [1]
302033
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None
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Name [1]
302033
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Address [1]
302033
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Country [1]
302033
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302869
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
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27 Victoria Parade Fitzroy VIC 3065
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Ethics committee country [1]
302869
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Australia
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Date submitted for ethics approval [1]
302869
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17/12/2018
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Approval date [1]
302869
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04/03/2019
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Ethics approval number [1]
302869
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HREC 275/18
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Summary
Brief summary
This study aims to compare how effectively a closed-loop automated insulin delivery system maintains an individual’s glucose levels in a healthy range compared with insulin delivered via a pump with doses determined in a manual way together with continuous glucose monitoring (CGM) via a glucose sensor. All participants will undertake the study over a 9 to 11-month period, completing two study stages in random order, each of 4-month duration 1) Closed-loop with automated basal insulin delivery, 2) Open-loop with manual insulin delivery via pump and CGM. Outcomes of interest include glucose levels and other non-glucose parameters such as physical well-being, cognitive functioning, psychosocial well-being, sleep, glucose patterns while driving and caregiver burden. These results will help us to understand whether automated insulin delivery systems may benefit an older cohort, and help to further refine systems for future iterations.
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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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Dr Sybil McAuley
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Address
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Department of Medicine
University of Melbourne, St Vincent's Hospital Melbourne
29 Regent St Fitzroy
Melbourne, Victoria 3065
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Country
91670
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Australia
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Phone
91670
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+61 3 9231 2211
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Fax
91670
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Email
91670
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[email protected]
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Contact person for public queries
Name
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Charlotte Grills
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Address
91671
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Department of Medicine
University of Melbourne, St Vincent's Hospital Melbourne
29 Regent St Fitzroy
Melbourne, Victoria 3065
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Country
91671
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Australia
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Phone
91671
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+61 3 9231 3648
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Fax
91671
0
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Email
91671
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[email protected]
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Contact person for scientific queries
Name
91672
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Sybil McAuley
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Address
91672
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Department of Medicine
University of Melbourne, St Vincent's Hospital Melbourne
29 Regent St Fitzroy
Melbourne, Victoria 3065
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Country
91672
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Australia
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Phone
91672
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+61 3 9231 2211
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Fax
91672
0
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Email
91672
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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)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
10412
Statistical analysis plan
377153-(Uploaded-11-12-2020-08-26-10)-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
Source
Title
Year of Publication
DOI
Embase
Closed-Loop Insulin Delivery Effects on Glycemia during Sleep and Sleep Quality in Older Adults with Type 1 Diabetes: Results from the ORACL Trial.
2022
https://dx.doi.org/10.1089/dia.2022.0110
Embase
Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial.
2022
https://dx.doi.org/10.2337/dc21-1667
Embase
Glucose profiles of older adults with type 1 diabetes using sensor-augmented pump therapy in Australia: pre-randomisation results from the ORACL study.
2022
https://dx.doi.org/10.1016/S2666-7568%2822%2900266-5
Embase
Lived experience of older adults with type 1 diabetes using closed-loop automated insulin delivery in a randomised trial.
2023
https://dx.doi.org/10.1111/dme.15020
N.B. These documents automatically identified may not have been verified by the study sponsor.
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