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Trial registered on ANZCTR


Registration number
ACTRN12621000912886
Ethics application status
Approved
Date submitted
4/06/2021
Date registered
14/07/2021
Date last updated
14/07/2021
Date data sharing statement initially provided
14/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Automated Patch-Pump Insulin Delivery System in Adults with Type 1 Diabetes
Scientific title
Feasibility study for Development of an All-In-One Combined Insulin Cannula and Glucose Sensor as Part of a Patch-Pump Closed Loop Insulin Delivery System in Adults with Type 1 Diabetes (Phase 1)
Secondary ID [1] 304369 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 322159 0
Condition category
Condition code
Metabolic and Endocrine 319851 319851 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Phase 1 of the study will be completed before commencing on Phase 2. Participants in Phase 1 of the study will be offered the option of participating in Phase 2 of the study - this will be registered in a separate record.

Phase 1: 50% insulin bolus for a carbohydrate load
- the EOPatch pump will be used during two in-clinic visits (up to 8 hours each including baseline measurements, EOPatch pump insertion/programming and meal challenge) conducted by a doctor and nurse experienced in managing hypo/hyperglycaemia during daylight hours in a major university hospital with a full resuscitation team available if necessary
- the EOPatch pump will be inserted by study staff at the start of the in-clinic visit for the meal challenge and removed at the end of each meal challenge
- participants will receive (in randomized order) a full insulin bolus (100%) and an underestimated insulin bolus (50%) during the meal challenge with a carbohydrate load (80g high carbohydrate meal) and have monitoring of glycaemia over 6 hours
- the first and second meal challenge will be 5-7 days apart (to avoid weekends so as to allow for access to a full resuscitation team, which will be difficult on weekends)

EOPatch pump use will be monitored on a regular basis (during the 30-minutely blood glucose checks) to ensure participants are in Auto mode during the meal challenges in the in-clinic visits and pump analytics can be accessed to verify that. Check-in and discharge times for these in-clinic visit will be documented in the case report forms.
Intervention code [1] 320733 0
Treatment: Devices
Comparator / control treatment
Phase 1: 100% insulin bolus for carbohydrate load
- during the meal challenge with a carbohydrate load, participants in this arm are given the full 100% insulin bolus via the EOPatch pump for the carbohydrate load
Control group
Active

Outcomes
Primary outcome [1] 327720 0
Percentage of time in target glucose range (TIR) 3.9-10 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [1] 327720 0
For 6 hours post commencement of meal challenge
Secondary outcome [1] 396335 0
Percentage of time >10 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [1] 396335 0
For 6 hours post commencement of meal challenge
Secondary outcome [2] 396336 0
Glycaemic excursion (peak glucose minus baseline) measured by Dexcom G6 continuous glucose monitor
Timepoint [2] 396336 0
For 6 hours post commencement of meal challenge
Secondary outcome [3] 396337 0
Percentage of time >13.9 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [3] 396337 0
For 6 hours post commencement of meal challenge
Secondary outcome [4] 396338 0
Percentage of time <3.9 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [4] 396338 0
For 6 hours post commencement of meal challenge
Secondary outcome [5] 396339 0
Percentage of time <3.0 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [5] 396339 0
For 6 hours post commencement of meal challenge
Secondary outcome [6] 396340 0
Occurrence of adverse events and serious adverse events, including:
- altered glucose levels (hyper/hypoglycaemia) will be assessed by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels during meal challenges
- any other participant reported adverse events during follow-up phone calls or patient-initiated contact
Timepoint [6] 396340 0
During meal challenge (6 hours) and for the next 7 days prior to the next meal challenge
Secondary outcome [7] 396341 0
Mean glucose measured by Dexcom G6 continuous glucose monitor
Timepoint [7] 396341 0
For 6 hours post commencement of meal challenge
Secondary outcome [8] 397425 0
Incidence rate of hypoglycaemia with glucose levels <3.9 mmol/L measured by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels
Timepoint [8] 397425 0
For 6 hours post commencement of meal challenge
Secondary outcome [9] 397426 0
Incidence rate of hypoglycaemia with glucose levels <3.0 mmol/L measured by Dexcom G6 continuous glucose monitor and 30-minutely fingerstick blood glucose levels
Timepoint [9] 397426 0
For 6 hours post commencement of meal challenge

Eligibility
Key inclusion criteria
- Type 1 diabetes, of at least 6 months duration.
- Age 21-75 Years
- Insulin pump usage at the time of screening and for at least 3 months prior to screening.
- HbA1c between 5.8% and 9.0%
- Willingness and ability to follow all study procedures and to attend all clinic visits.
- Living with a person knowledgeable regarding the management of hypoglycaemia.
- No episodes of diabetic ketoacidosis and severe hypoglycaemia within the last 3 months
Minimum age
21 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Chronic kidney disease as defined by estimated-GFR < 45 ml/min
- Inability to read pump or CGM display due to reduced visual acuity
- Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- Cognitive limitations precluding the participant’s ability to operate the insulin pump.
- Any major active medical condition which in the investigator’s opinion precludes involvement in the study. Known active infection such as HIV or hepatitis
- Schizophrenia or other untreated mental illness
- Chronic substance abuse
- Major surgical procedure within 30 days prior to screening
- Bleeding disorder, or treatment with anticoagulants
- Allergy to Lispro insulin
- Allergy to acrylate-based skin adhesives
- Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
- Diabetic ketoacidosis or major hypoglycemia within the last 6 months
- Insulin resistance as defined by insulin requirement of more than 200 units per day
- Use of glucose-lowering medications other than insulin
- Need for uninterrupted treatment with acetaminophen

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 concealed
This is done through central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerized sequence generation
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 feasibility study is exploratory for data generation to determine sample size for larger studies. The sample size for this study is based on experience with prototype closed loop studies.




Recruitment
Recruitment status
Not yet 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] 19606 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34241 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 308741 0
Commercial sector/Industry
Name [1] 308741 0
EOFlow Inc
Address [1] 308741 0
15 Rye Street, Suite #307, Portsmouth, New Hampshire USA 03801
Country [1] 308741 0
United States of America
Primary sponsor type
Hospital
Name
St Vincent's Hospital Melbourne
Address
41 Victoria Parade, Fitzroy, Victoria 3065
Country
Australia
Secondary sponsor category [1] 309637 0
None
Name [1] 309637 0
Address [1] 309637 0
Country [1] 309637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308661 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 308661 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 308661 0
Australia
Date submitted for ethics approval [1] 308661 0
07/04/2021
Approval date [1] 308661 0
26/05/2021
Ethics approval number [1] 308661 0
HREC 079/21

Summary
Brief summary
Phase 1 of the study will obtain safety data for the investigational automated insulin delivery EOPatch pump.

We hypothesize that the EOPatch pump is as safe and is as effective at reducing post-prandial blood glucose excursions in persons with Type 1 diabetes who under-bolus mealtime insulin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111462 0
Prof David O'Neal
Address 111462 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111462 0
Australia
Phone 111462 0
+61 425731665
Fax 111462 0
Email 111462 0
dno@unimelb.edu.au
Contact person for public queries
Name 111463 0
Dr Yee Wen Kong
Address 111463 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111463 0
Australia
Phone 111463 0
+61 433593020
Fax 111463 0
Email 111463 0
kongyw@unimelb.edu.au
Contact person for scientific queries
Name 111464 0
Prof David O'Neal
Address 111464 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 111464 0
Australia
Phone 111464 0
+61 425731665
Fax 111464 0
Email 111464 0
dno@unimelb.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