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Trial registered on ANZCTR


Registration number
ACTRN12620001191987
Ethics application status
Approved
Date submitted
29/08/2020
Date registered
10/11/2020
Date last updated
15/06/2021
Date data sharing statement initially provided
10/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to Assess the Performance of Do-It-Yourself Artificial Pancreas in Adults with Type 1 Diabetes.
Scientific title
A Feasibility Study Examining the Safety and Efficacy of a Do-It-Yourself Artificial Pancreas; a Hybrid Closed loop Android Artificial Pancreas System (AndroidAPS) in Adults with Type 1 Diabetes
Secondary ID [1] 302175 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 318839 0
Condition category
Condition code
Metabolic and Endocrine 316844 316844 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention in this study is 4-week use of a Hybrid Closed loop Android Artificial Pancreas System (AndroidAPS) in patients with type 1 diabetes.

Android APS consists of three main components:
1. Dexcom G5® Continuous Glucose Monitoring (CGM): includes a glucose sensor and transmitter attached to the user with ability to measure interstitial fluid glucose continuously. The CGM data are transferred via Bluetooth to Dexcom G5® mobile App (an application on the study android phone). The App can display real time glucose data.
2. Upgraded YpsoPump® insulin pump: An upgraded version of YpsoPump® with bidirectional communication capability will be developed for the purpose of this study to enable communication with AndroidAPS interface.YpsoPump has been approved and is currently being used in Australia.
3. AndroidAPS App: an application on the study android phone which contains the controller algorithm. It receives real time CGM data from Dexcom G5® mobile App and controls the basal insulin delivery by sending commands to YpsoPump®. The basal insulin delivery rate is adjusted every 5 minutes based on varying glucose levels. When it comes to meal bolus, participant needs to enter carbohydrate content of the meal (meal announcement) into the AndroidAPS and the integrated bolus calculator within the App (based on settings determined by the investigators) calculates the required bolus dose which is then sent as a command to YpsoPump® to deliver the dose. Because the system requires meal announcement, it is a hybrid closed-loop system.

- Using Ypsopump involves wearing an insulin pump connected to the body via an insulin infusion set. The infusion set is inserted via a serter.

- Participants will be admitted to the clinical trial ward for 24 hours for initialization of AndroidAPS system and supervision. The following will be performed:
1. Dexcom CGM will be inserted and participants will be educated about CGM insertion by a diabetes nurse educator.
2. CGM will be linked via transmitter to the Android and Ypsomed pump.
3. Patients will be educated to use the system component including Ypsomed pump, CGM, android phone and associated apps.
4. AndroidAPS will be activated

- The day after discharge from the clinical trail ward, participants will be phoned by the study coordinator to assess patient welfare. Data will be reviewed remotely. Clinical investigators will be granted remote access to the participants' real time glucose and insulin delivery data allowing them to follow participants' data remotely throughout this arm of the trial. One week and 3 weeks into intervention, participants will attend clinical trial centre and following will be performed:
1. Participants will be reviewed by Endocrinologist, diabetes educator and research coordinator.
2. Their pump will be uploaded and pump settings will be optimized.

- Duration of wash-out period between intervention and control arms is 1 week.
Intervention code [1] 318481 0
Treatment: Devices
Comparator / control treatment
The control arm is 4-week use of conventional insulin pump therapy in patients with type 1 diabetes.
Conventional pump therapy involves using YpsoPump® insulin pump stand-alone (without CGM).

- During control arm, participants will monitor glucose levels by finger-prick capillary blood glucose measurements.

- Insulin pump will be running at a pre-set basal insulin delivery rate . In regards to bolus insulin dosing, participants put their finger-prick capillary glucose levels as well as carbohydrate counting data into the App and the integrated bolus calculator enables them to calculate meal time or correctional bolus insulin doses (the settings of bolus calculator are determined by investigators). Participants will then administer the dose via pump by manually entering the suggested bolus dose into the pump.
Control group
Active

Outcomes
Primary outcome [1] 324961 0
Percentage of CGM time in target range (3.9-10.0 mmol/L) with AndroidAPS vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [1] 324961 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [1] 386348 0
Mean sensor glucose value with AndroidAPS compared vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [1] 386348 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [2] 386349 0
Percentage of CGM time in hypoglycaemia range (< 3.9 mmol/L) with AndroidAPS compared vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [2] 386349 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [3] 386350 0
Percentage of CGM time in clinically significant hypoglycaemia range (< 3.0 mmol/L) with AndroidAPS vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [3] 386350 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [4] 386351 0
Percentage of CGM time in hyperglycaemia range (> 10.0 mmol/L) with AndroidAPS vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [4] 386351 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [5] 386352 0
Percentage of CGM time in significant hyperglycaemic range (> 13.9 mmol/L) with AndroidAPS vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [5] 386352 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [6] 386353 0
Parameters of Glycaemic variability will be assessed by measuring standard deviation of the mean (SD) , co-efficient of variation (CV) and Mean Amplitude of Glycaemic Excursion (MAGE) with AndroidAPS vs conventional pump therapy as measured by masked CGM (iPro®2) in the final week of 4 week-study arm.
Timepoint [6] 386353 0
Continiously during Week 4 for each of the intervention and control periods.
Secondary outcome [7] 386354 0
Number of symptomatic episodes of hypoglycaemia with AndroidAPS vs conventional pump therapy as reported by participants and documented in their study diary.
Timepoint [7] 386354 0
Entire duration (week 1-4) for each of the intervention and control periods.
Secondary outcome [8] 386355 0
Number of severe adverse events (severe hypoglycaemic and diabetic ketoacidosis) with AndroidAPS vs conventional pump therapy as reported by the participant or determined by the study team. The nature of the adverse events will be determined by revieweing hospital admission and/or ambulance records.
Timepoint [8] 386355 0
Entire duration (week 1-4) for each of the intervention and control periods.
Secondary outcome [9] 386356 0
Average total daily dose of insulin with AndroidAPS vs conventional pump therapy as per uploaded insulin pump data.
Timepoint [9] 386356 0
Entire duration (week 1-4) for each of the intervention and control periods
Secondary outcome [10] 386357 0
Change in body weight with AndroidAPS compared with conventional pump therapy as measured by study team. Body weight will be measured by digital scale.
Timepoint [10] 386357 0
Final day (Day 28) for each of the intervention and control periods
Secondary outcome [11] 386358 0
Treatment satisfaction with AndroidAPS compared with conventional pump therapy as assessed by Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Timepoint [11] 386358 0
Final day (Day 28) for each of the intervention and control periods.
Secondary outcome [12] 386359 0
Diabetes distress with AndroidAPS compared with conventional pump therapy as assessed by Problem Areas in Diabetes (PAID)
Timepoint [12] 386359 0
Final day (Day 28) for each of the intervention and control periods
Secondary outcome [13] 386360 0
Fear of hypoglycaemia with AndroidAPS compared with conventional pump therapy as assessed by Hypoglycaemia Fear Survey-II short form
Timepoint [13] 386360 0
Final day (Day 28) for each of the intervention and control periods
Secondary outcome [14] 386361 0
Hypoglycaemia awareness with AndroidAPS compared with conventional pump therapy as assessed by Clarke hypoglycaemia awareness survey.
Timepoint [14] 386361 0
Final day (Day 28) for each of the intervention and control periods

Eligibility
Key inclusion criteria
• Type 1 diabetes greater than or equal to 6 months duration
• Adults age greater than or equal to 18 years
• Insulin pump therapy greater than or equal to 6 months duration
• HbA1c less than 10.0%
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Pregnancy
• Current use of real time CGM in the previous 3 months
• Hospitalization for severe hypoglycaemia or ketoacidosis in the past 6 months
• Chronic kidney disease (eGFR < 45 mL/min/1.73m2)
• Planned international travel during the study period
• Oral hypoglycaemic agents or non insulin injectable agents within past 4 weeks

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization will be performed by a random number generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
This represents a proof of concept study with limited data available regarding AndroidAPS performance. Based upon previous published data, we anticipate that use of hybrid closed-loop insulin delivery system for 4 weeks will improve the time in target range between 3.9 and 10.0mmol/L by a mean of 10.5% (95% CI 7·6–13·4%) compared to usual pump therapy. Assuming an improvement in time in target range of 12% and conventional deviation of 8%, 17 participants were needed to provide 80% power at 5% a level. We plan to recruit 20 subjects in total allowing for dropout rate of 15%. Analysis will be performed using ANOVA and paired t-test where applicable.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17371 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 31100 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306599 0
Commercial sector/Industry
Name [1] 306599 0
Ypsomed Australia Pty Ltd
Address [1] 306599 0
602/20 Bungan St, Mona Vale NSW 2103
Country [1] 306599 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker Heart and Diabetes Institute
Address
99 Commercial Road, Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 307130 0
None
Name [1] 307130 0
Address [1] 307130 0
Country [1] 307130 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306784 0
Bellberry Limited
Ethics committee address [1] 306784 0
123 Glen OsmondRoad, Eastwood, SA, 5063
Ethics committee country [1] 306784 0
Australia
Date submitted for ethics approval [1] 306784 0
29/07/2019
Approval date [1] 306784 0
02/03/2020
Ethics approval number [1] 306784 0
HREC2019-07-645

Summary
Brief summary
Android artificial pancreas system (APS), uses an algorithm housed on an android phone in association with a Dexcom continuous glucose monitoring (CGM) system. An insulin pump that communicates with both the android APS software and Dexcom continuous glucose monitoring system is required and we will be using a modified Ypsopump in this trial.
The aim of this study is to assess the safety and efficacy of a hybrid closed loop Android Artificial Pancreas System compared with conventional pump therapy using a standard Ypsopump.
All participants will trial both the Android APS system and conventional insulin pump therapy for 4 weeks each.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105010 0
A/Prof Neale Cohen
Address 105010 0
Baker Heart and Diabetes Institute
75 Commercial Road, Melbourne, VIC, 3004
Country 105010 0
Australia
Phone 105010 0
+61385321800
Fax 105010 0
Email 105010 0
neale.cohen@baker.edu.au
Contact person for public queries
Name 105011 0
Dr Amin Sharifi
Address 105011 0
Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road, Melbourne, VIC, 3004
Country 105011 0
Australia
Phone 105011 0
+61385321800
Fax 105011 0
Email 105011 0
amin.sharifi@baker.edu.au
Contact person for scientific queries
Name 105012 0
Dr Amin Sharifi
Address 105012 0
Baker Heart and Diabetes Institute
Level 4, 99 Commercial Road, Melbourne, VIC, 3004
Country 105012 0
Australia
Phone 105012 0
+61385321800
Fax 105012 0
Email 105012 0
amin.sharifi@baker.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results