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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04503564




Registration number
NCT04503564
Ethics application status
Date submitted
9/07/2020
Date registered
7/08/2020
Date last updated
26/01/2021

Titles & IDs
Public title
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Scientific title
Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants
Secondary ID [1] 0 0
ACTRN12620000021976
Secondary ID [2] 0 0
150-1072-00
Universal Trial Number (UTN)
Trial acronym
FEXIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 1 0 0
Type 1 Diabetes 0 0
Type 1 Diabetes Mellitus 0 0
Diabetes Mellitus, Insulin-Dependent, 1 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - coil-reinforced soft polymer indwelling cannula

Treatment: Devices: coil-reinforced soft polymer indwelling cannula
This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Feasibility: Continuous Glucose Monitor (CGM) readings - The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.
The composite primary objective of this study will be assessed through Continuous Glucose Monitor (CGM) readings in coordination with pump data. CGM readings will indicate how well the device performs in terms of insulin absorption, indicated by pump boluses. Therefore, a comparison of time of pump bolus and the CGM readings over the course of two to three hours will be made to asses if the device was successful in delivering insulin to the body to absorb
Timepoint [1] 0 0
Week 1, Week 2 and week 3
Secondary outcome [1] 0 0
BG control - Evaluation of, Standard glucose control measures obtained from Continuous Glucose Monitoring (CGM), including observed hyper- and hypoglycemic episodes.
This outcome will be assessed by means of CGM readings and participant diary.
Timepoint [1] 0 0
Week 2 and week 3
Secondary outcome [2] 0 0
Tolerability: VAS (Visual Analog Scale) - Evaluation of, Subject tolerability (subject comfort) during wear period. This outcome will be assessed by means of a Participant diary, which includes a Visual Pain Scale (VAS), to be filled daily with the participant's feedback and pain level of wearing the device. Furthest left means no pain; furthest right means extreme pain as perceived by the participant. The line is a continuum from none to an extreme amount of pain
Timepoint [2] 0 0
Week 1, Week 2 and Week 3

Eligibility
Key inclusion criteria
1. Participant is 18 - 70 years of age inclusive

2. Participant is in generally good health, as determined by the investigator

3. Participant is willing and able to individually complete written informed consent and
agrees to comply with all study related testing and examinations

4. Participant must be geographically stable (e.g., expects to be available and capable
of returning for all study specified test and examinations) during the study period

5. Participant has been diagnosed with T1DM for at least 12 months

6. C-peptide less than 0.6 nmol per L at screening

7. Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use
compliance

8. Participant is willing to perform serum ketone measurements whenever the blood glucose
is determined to be greater than 250 mg per dL (14 mmol per L) using a ketone meter
and strips provided by the sponsor

9. Participant has BMI in the range 20 - 35 kg per square metre inclusive

10. Participant has experience infusing a rapid-acting insulin analog for at least 6
months

11. Participant has been using an insulin pump with commercially available infusion sets
for at least 6 months (this includes Automated Insulin Delivery systems)

12. Participant has previous experience using a continuous glucose monitor (CGM) and is
willing to use a CGM for the duration of the study and perform necessary calibration
fingerstick glucose readings

13. Participant has ability to understand and comply with protocol procedures and to
provide informed consent

14. AST and ALT less than or equal to 120 U per L

15. Creatinine less than 1.8 mg per dL
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participants whose average total daily insulin dose exceeds 85 units per day (i.e.
typically change insulin reservoirs more often than every 3.5 days on average)

2. Participants who routinely change their commercial insulin infusion sets twice weekly
or less often (wear time greater than 3.5 days)

3. Female participant is pregnant or nursing (Documented negative pregnancy test results
for female participants required unless participant is menopausal without any
spontaneous menstrual cycles for >12 months or key organs have been removed.)

4. Participant has abnormal skin at intended device infusion sites (existing infection,
inflammation, burns, or other extensive scarring)

5. Participant has HbA1C greater than 8.5 percent at screening

6. Participant has documented history in last 6 months of severe hypoglycemia associated
with cognitive dysfunction sufficiently severe to require third party intervention or
a history of impaired awareness of hypoglycemia.

7. Participant has a history of diabetic ketoacidosis in the last 6 months

8. Participant has known cardiovascular disease considered to be clinically relevant by
the investigator

9. Participant has known arrhythmias considered to be clinically relevant by the
investigator

10. Participant has known history of:

1. Cushing's Disease,

2. pancreatic islet cell tumor, or

3. insulinoma

11. Participant has:

1. Lipodystrophy,

2. extensive lipohypertrophy, as assessed by the investigator

12. Participant is undergoing current treatment with:

1. Systemic oral or intravenous corticosteroids,

2. monoamine oxidase (MAO) inhibitors,

3. non-selective beta-blockers,

4. growth hormone,

5. thyroid hormones, unless use has been stable during the past 3 months

13. Subject has significant history of any of the following, that in the opinion of the
investigator would compromise the subject's safety or successful study participation:

1. Alcoholism,

2. drug abuse

14. Significant acute or chronic illness, that in the investigator's opinion, might
interfere with subject safety or integrity of study results

15. Planned operation, MRI or CT which require removal of infusion set or CGM sensor
during wear periods

16. Current participation in another clinical drug or device study

17. AST and ALT greater than 120 U per L

18. Creatinine equal to or greater than 1.8 mg per dL -

Study design
Purpose of the study
Device Feasibility
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
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)
Recruitment hospital [1] 0 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Capillary Biomedical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using
continuous subcutaneous insulin infusion with an infusion set that needs to be changed every
3 days. This study will assess the feasibility and device performance of the study device,
the Achilles infusion set over three periods during routine insulin infusion.

This study will include 20 participants and has 3 periods:

Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7
days): participants will manage their blood glucose solely with their insulin pump and the
Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose
monitoring (CGM) device.

Period 3 (up to 7 days): Participants will return to study centre to receive a fresh Achilles
infusion set and continue blood glucose management at home until infusion set failure or 7
days.
Trial website
https://clinicaltrials.gov/show/NCT04503564
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David O'Neal, M.D.
Address 0 0
St Vincent's Hospital Department of Medicine
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications