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Trial registered on ANZCTR


Registration number
ACTRN12620000687998
Ethics application status
Approved
Date submitted
20/05/2020
Date registered
18/06/2020
Date last updated
18/06/2020
Date data sharing statement initially provided
18/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Faster acting insulin aspart (FiASP) vs. insulin aspart using an advanced closed-loop system in type 1 diabetes: 12-month free living study
Scientific title
Evaluation of PostPrandial Glucose Control with the Medtronic Advanced Hybrid Closed Loop System (A-HCL): 12-month free living study in adults with type 1 diabetes
Secondary ID [1] 301339 0
Nil
Universal Trial Number (UTN)
U1111-1252-3476
Trial acronym
Linked study record
U1111-1217-1398 / ACTRN12619000469112
This study is an extension of the previously registered study (ACTRN12619000469112); comparing FiAsp vs. insulin aspart using the same study device in free-living conditions.

Health condition
Health condition(s) or problem(s) studied:
type 1 diabetes 317544 0
Condition category
Condition code
Metabolic and Endocrine 315635 315635 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This follow-up 12-month observational study aims to assess the performance of an advanced hybrid closed loop (A-HCL) system delivering faster-acting insulin aspart (FiAsp) versus insulin aspart for adults with type 1 diabetes under 'free-living' conditions.

This follows on from a completed pilot study that evaluated the performance of the A-HCL system delivering FiAsp versus aspart during standardised meal and exercise interventions.

It is evident that evaluation of investigational devices for improving glucose control under clinically rigorous conditions is likely to provide data on performance that may be unrealistic when compared to “real-life” situations. Therefore, it is important to test these devices in real-world conditions without experimental intervention from the study team.

Participants who were enrolled in ACTRN12619000469112 will be eligible to participate in this study. This study will allow participants to undergo their normal daily activities whilst utilising the A-HCL pump. Pump settings will be adjusted as per usual clinical care by the study team. Participants will be free to utilize insulin aspart or FiAsp with the pump based upon their personal preference. Participants will upload their pump regularly to allow the study team to monitor the safety of the device.

Twelve participants are planned to undertake the study at one clinical site. All procedures involving study participants will be undertaken by study doctors and research nurses. Participants will receive regular text message and phone call reminders during each stage of the study to ensure adherence.
Intervention code [1] 317635 0
Not applicable
Comparator / control treatment
Control treatment involves using insulin aspart.
Control group
Active

Outcomes
Primary outcome [1] 323871 0
Time spent with sensor glucose 3.9–10.0 mmol/L using uploaded CGM data
Timepoint [1] 323871 0
Entire 12-month study duration
Secondary outcome [1] 383094 0
Time spent with sensor glucose <3.0mmol/L using uploaded CGM data
Timepoint [1] 383094 0
Entire 12-month study duration
Secondary outcome [2] 383095 0
Time spent with sensor glucose <3.9mmol/L using uploaded CGM data
Timepoint [2] 383095 0
Entire 12-month study duration
Secondary outcome [3] 383096 0
Time spent with sensor glucose 3.9–7.8 mmol/L using uploaded CGM data
Timepoint [3] 383096 0
Entire 12-month study duration
Secondary outcome [4] 383097 0
Time spent with sensor glucose >10.0mmol/L using uploaded CGM data
Timepoint [4] 383097 0
Entire 12-month study duration
Secondary outcome [5] 383098 0
Time spent with sensor glucose >13.9mmol/L using uploaded CGM data
Timepoint [5] 383098 0
Entire 12-month study duration
Secondary outcome [6] 383099 0
Time spent with sensor glucose >16.7mmol/L using uploaded CGM data
Timepoint [6] 383099 0
Entire 12-month study duration
Secondary outcome [7] 383100 0
Sensor glucose variability (standard deviation) and coefficient of variation using uploaded CGM data
Timepoint [7] 383100 0
Entire 12-month study duration
Secondary outcome [8] 383101 0
Major hypoglycaemic episodes (n) defined as requiring third party assistance (self-reported)
Timepoint [8] 383101 0
Cumulative total of this outcome (n) will be analysed throughout the entire 12-month study period
Secondary outcome [9] 383102 0
Episodes of ketosis (n) defined as a blood ketone level > 0.6mmol/L on finger-prick ketone testing
Timepoint [9] 383102 0
Cumulative total of this outcome (n) will be analysed throughout the entire 12-month study period
Secondary outcome [10] 383103 0
Episodes of ketoacidosis (n) measured using finger-prick ketone testing and blood gas analysis in hospital
Timepoint [10] 383103 0
This will only occur if the participant becomes unwell, is ketotic on finger-prick ketone testing and admission to hospital is clinically indicated.

Cumulative total of this outcome (n) will be analysed throughout the entire 12-month study period
Secondary outcome [11] 383104 0
Unscheduled exits from closed-loop (CL) (n) using uploaded CGM data
Timepoint [11] 383104 0
Entire 12-month study duration
Secondary outcome [12] 383105 0
Time (%) in CL using uploaded CGM data
Timepoint [12] 383105 0
Entire 12-month study duration
Secondary outcome [13] 383106 0
Total insulin delivery (units) using uploaded CGM data
Timepoint [13] 383106 0
Entire 12-month study duration
Secondary outcome [14] 383107 0
Sensor mean absolute relative difference (MARD) with glucose meter as a reference, using uploaded CGM and glucose meter data
Timepoint [14] 383107 0
Entire 12-month study duration
Secondary outcome [15] 383108 0
Insulin delivery line-set changes (n) using uploaded CGM data
Timepoint [15] 383108 0
Entire 12-month study duration
Secondary outcome [16] 383109 0
Line occlusion alarms (n) using uploaded CGM data
Timepoint [16] 383109 0
Entire 12-month study duration

Eligibility
Key inclusion criteria
Only those participants who were enrolled in ACTRN12619000469112 will be eligible to participate in this study.

Pre-existing inclusion criteria:
Type 1 diabetes of >1 year duration
Stable on insulin pump therapy for >3 months
Proficient in carbohydrate counting
Continuous glucose monitoring (CGM) sensor experience
HbA1c <10.0%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy
eGFR <40ml/min/1.73m2
History of diabetic ketoacidosis or severe hypoglycaemia in the last 3 months
Diabetic gastroparesis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
This represents an exploratory trial to provide preliminary data on the A-HCL performance in 'free-living' conditions with FiAsp compared with insulin aspart. The participant numbers were determined for the initial feasibility study and therefore (n) for this opportunistic extension study has been predetermined.

Median and IQR of primary and all secondary outcomes will be reported for the total duration of the study. Device performance outcomes will be presented for overall duration of the study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/06/2020
Actual
Date of last participant enrolment
Anticipated
29/06/2020
Actual
Date of last data collection
Anticipated
29/06/2021
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16727 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 30329 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 305773 0
Hospital
Name [1] 305773 0
St Vincent's Hospital Melbourne
Country [1] 305773 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Diabetes
Address
18000 Devonshire Street
Northridge CA 91325
Country
United States of America
Secondary sponsor category [1] 306213 0
None
Name [1] 306213 0
Address [1] 306213 0
Country [1] 306213 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306046 0
St Vincent's Hospital Melbourne HREC
Ethics committee address [1] 306046 0
Ethics committee country [1] 306046 0
Australia
Date submitted for ethics approval [1] 306046 0
15/04/2020
Approval date [1] 306046 0
15/06/2020
Ethics approval number [1] 306046 0
HREC 067/20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102534 0
Prof David O'Neal
Address 102534 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 102534 0
Australia
Phone 102534 0
+61 3 9231 2211
Fax 102534 0
Email 102534 0
[email protected]
Contact person for public queries
Name 102535 0
Melissa Lee
Address 102535 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 102535 0
Australia
Phone 102535 0
+61 3 9231 2211
Fax 102535 0
Email 102535 0
[email protected]
Contact person for scientific queries
Name 102536 0
Melissa Lee
Address 102536 0
St Vincent's Hospital Melbourne
41 Victoria Parade
Fitzroy VIC 3065
Country 102536 0
Australia
Phone 102536 0
+61 3 9231 2211
Fax 102536 0
Email 102536 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?

No Supporting Document Provided



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.