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Trial registered on ANZCTR


Registration number
ACTRN12621001241820
Ethics application status
Approved
Date submitted
4/08/2021
Date registered
14/09/2021
Date last updated
4/04/2024
Date data sharing statement initially provided
14/09/2021
Type of registration
Retrospectively 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 (Phase 2)
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 2)
Secondary ID [1] 304638 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record
This record involves the investigational device (EOFlow patch pump) in the study ACTRN12621000912886.

Health condition
Health condition(s) or problem(s) studied:
Type 1 diabetes 322581 0
Condition category
Condition code
Metabolic and Endocrine 320192 320192 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in Phase 1 of the study (ACTRN12621000912886) will be offered the option of participating in Phase 2 of the study.

Phase 2: Insulin in Tandem pump and Saline in EOPatch pump
- the EOPatch pump and Tandem pump (delivering via the PDT device) will be used during two in-clinic visits (up to 9 hours each including insertion of devices, baseline measurements and meal challenge) for meal challenges (80g high carbohydrate meal) 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 Tandem pump will be inserted at the start of the study (Day 0) and paired with a Dexcom G6 continuous glucose monitor (CGM) in open loop. The participant's own insulin pump will be disconnected. The Tandem pump will remain in situ until the end of the study. Education for the use of the Tandem pump, Dexcom G6 CGM and Contour Next One meter will also be delivered during this session.
- the PDT device is inserted by study staff at the start of the in-clinic visit for the first meal challenge (Day 14) and the Tandem pump will be connected to it
- the EOPatch pump will be inserted by study staff at the start of the in-clinic visit for the meal challenge (Day 14 and 18) and removed at the end of each meal challenge
- the order of the meal challenges, in which participants receive closed loop insulin delivery from either EOPatch pump or Tandem Control-IQ system (delivering via PDT device) and saline through the other device, will be randomized, and participants will have monitoring of glycaemia over 6 hours after the carbohydrate load
- a 100% insulin bolus based on the participant's insulin to carbohydrate ratio (ICR) will be delivered through one pump and replication of the same volume of saline will be delivered through the other pump
- the EOPatch pump will be removed after the meal challenge and all participants will go home with the Tandem Control-IQ system (delivering insulin via PDT device) in open loop until their next in-clinic visit for the second meal challenge (4 days later)
- the 2 meal tests will be 4 days apart
Intervention code [1] 320986 0
Treatment: Devices
Comparator / control treatment
Phase 2: Saline in Tandem pump and Insulin in EOPatch pump
- during the meal challenge with a carbohydrate load, participants in this arm are given the appropriate insulin bolus dose via the EOPatch pump in closed loop, with replication of the same volume of saline delivered by the Tandem pump via the PDT cannula in closed loop
Control group
Active

Outcomes
Primary outcome [1] 328069 0
PDT sensor accuracy as determined by mean absolute relative difference (MARD) between PDT sensor readings and reference YSI (Yellow Springs Instrument) venous blood glucose measurements
Timepoint [1] 328069 0
For 6 hours post commencement of meal challenge
Secondary outcome [1] 397446 0
Incidence of unexplained glycemic excursions, measured by Dexcom G6 continuous glucose monitor, requiring a PDT sensing cannula or EOPatch pump change
Timepoint [1] 397446 0
For 6 hours post commencement of meal challenge and 4 days after PDT sensing cannula is inserted at the first meal challenge
Secondary outcome [2] 397447 0
Mean scores on Tolerability questionnaire (designed specifically for this study) assessing subjective participant tolerability of the PDT sensing cannula
Timepoint [2] 397447 0
15 minutes after insertion of PDT sensing cannula during first meal challenge and after the first meal challenge, before and after the second meal challenge
Secondary outcome [3] 397448 0
Mean scores on Visual Analog Scale assessing subjective participant discomfort to the PDT sensing cannula
Timepoint [3] 397448 0
15 minutes after insertion of PDT sensing cannula during first meal challenge and after the first meal challenge, before and after the second meal challenge
Secondary outcome [4] 397449 0
Mean scores on Draize scale assessing objective changes reflecting skin reactions to PDT sensing cannula and EOPatch pump
Timepoint [4] 397449 0
Immediately post completion of second meal challenge
Secondary outcome [5] 397450 0
Percentage of time in target glucose range (TIR) 3.9-10 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [5] 397450 0
For 6 hours post commencement of meal challenge
Secondary outcome [6] 397451 0
Percentage of time >13.9 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [6] 397451 0
For 6 hours post commencement of meal challenge
Secondary outcome [7] 397460 0
Percentage of time >10.0mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [7] 397460 0
For 6 hours post commencement of meal challenge
Secondary outcome [8] 397462 0
Glycaemic excursion (peak glucose minus baseline) measured by Dexcom G6 continuous glucose monitor
Timepoint [8] 397462 0
For 6 hours post commencement of meal challenge
Secondary outcome [9] 397463 0
Percentage of time <3.9 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [9] 397463 0
For 6 hours post commencement of meal challenge
Secondary outcome [10] 397464 0
Percentage of time <3.0 mmol/L measured by Dexcom G6 continuous glucose monitor
Timepoint [10] 397464 0
For 6 hours post commencement of meal challenge
Secondary outcome [11] 397465 0
Mean glucose measured by Dexcom G6 continuous glucose monitor
Timepoint [11] 397465 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
Sex
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.
For Phase 2 data analysis: Glucose sensor accuracy (absolute relative difference) during insulin delivery will be calculated by using two types of calibration schemes: a one-point calibration with fixed offset, performed before meal administration; and a retrospective all point calibration as proposed for early device evaluation, as proposed by Heinemann and Lodwig. In addition to mean and median absolute relative difference, other accuracy metrics will include signed difference (bias). Error grid analyses will include Clarke, Parkes and continuous analyses. Bland-Altman analysis will be used to stratify accuracy as a function of glucose level.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Safety concerns
Date of first participant enrolment
Anticipated
31/10/2021
Actual
29/07/2021
Date of last participant enrolment
Anticipated
30/04/2022
Actual
6/08/2021
Date of last data collection
Anticipated
22/05/2022
Actual
Sample size
Target
18
Accrual to date
Final
3
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19813 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 34464 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 308998 0
Commercial sector/Industry
Name [1] 308998 0
EOFlow Inc
Country [1] 308998 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] 309934 0
None
Name [1] 309934 0
Address [1] 309934 0
Country [1] 309934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308889 0
St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC)
Ethics committee address [1] 308889 0
Ethics committee country [1] 308889 0
Australia
Date submitted for ethics approval [1] 308889 0
07/04/2021
Approval date [1] 308889 0
26/05/2021
Ethics approval number [1] 308889 0
HREC 079/21

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

Contacts
Principal investigator
Name 112230 0
Prof David O'Neal
Address 112230 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 112230 0
Australia
Phone 112230 0
+61425731665
Fax 112230 0
Email 112230 0
dno@unimelb.edu.au
Contact person for public queries
Name 112231 0
Yee Wen Kong
Address 112231 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 112231 0
Australia
Phone 112231 0
+61433593020
Fax 112231 0
Email 112231 0
kongyw@unimelb.edu.au
Contact person for scientific queries
Name 112232 0
David O'Neal
Address 112232 0
St Vincent’s Hospital (Melbourne)
41 Victoria Parade Fitzroy VIC 3065
Country 112232 0
Australia
Phone 112232 0
+61425731665
Fax 112232 0
Email 112232 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 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.