Diabetes Mellitus, Type 1FEXISNCT04503564
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
A study testing coil-reinforced soft polymer indwelling cannula in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Capillary Biomedical, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus
- What is being tested?
- coil-reinforced soft polymer indwelling cannula
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 13 Nov 2019to 11 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is 18 - 70 years of age inclusive
- Participant is in generally good health, as determined by the investigator
- Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
- 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
- Participant has been diagnosed with T1DM for at least 12 months
- C-peptide less than 0.6 nmol per L at screening
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- Subject can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
- 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
- Participant has BMI in the range 20 - 35 kg per square metre inclusive
- Participant has experience infusing a rapid-acting insulin analog for at least 6 months
- Participant has been using an insulin pump with commercially available infusion sets for at least 6 months (this includes Automated Insulin Delivery systems)
- 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
- Participant has ability to understand and comply with protocol procedures and to provide informed consent
- AST and ALT less than or equal to 120 U per L
- Creatinine less than 1.8 mg per dL
Who cannot join
- 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)
- Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time greater than 3.5 days)
- 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.)
- Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- Participant has HbA1C greater than 8.5 percent at screening
- 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.
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- Participant has a history of diabetic ketoacidosis in the last 6 months
- Participant has known cardiovascular disease considered to be clinically relevant by the investigator
- Participant has known arrhythmias considered to be clinically relevant by the investigator
- Participant has known history of:
- Cushing's Disease,
- pancreatic islet cell tumor, or
- insulinoma
- Participant has:
- Lipodystrophy,
- extensive lipohypertrophy, as assessed by the investigator
- Participant is undergoing current treatment with:
- Systemic oral or intravenous corticosteroids,
- monoamine oxidase (MAO) inhibitors,
- non-selective beta-blockers,
- growth hormone,
- thyroid hormones, unless use has been stable during the past 3 months
- 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:
- Alcoholism,
- drug abuse
- Significant acute or chronic illness, that in the investigator's opinion, might interfere with subject safety or integrity of study results
- Planned operation, MRI or CT which require removal of infusion set or CGM sensor during wear periods
- Current participation in another clinical drug or device study
- AST and ALT greater than 120 U per L
- Creatinine equal to or greater than 1.8 mg per dL -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants
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:
Read more
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 center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.
Read the detailed description
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).
The CapBio Achilles infusion set is a sterile single use device designed to be used with commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and three proximal holes.
The primary objective of this study is to determine feasibility and device performance of the CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes Mellitus, Insulin-Dependent, 1
- Being tested
- coil-reinforced soft polymer indwelling cannula
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coil-reinforced soft polymer indwelling cannulaDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Achilles Infusion Set | Experimental | Coil-reinforced soft polymer indwelling cannula Receives: Device: coil-reinforced soft polymer indwelling cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Infusion Set Survival at End of Day 7
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.
Measured: 7 days during weeks 2 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start13 Nov 2019
- Primary completion11 Nov 2020
- Study completion11 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is designed as a single arm device feasibility evaluation
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capillary Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David O'Neal, M.D., Principal investigator, St Vincent's Hospital Department of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503564
- Sponsor's protocol ID
- 150-1072-00
- Other IDs
- ACTRN12620000021976
- Acronym
- FEXIS
- Status last verified
- May 2022
- First submitted
- 9 Jul 2020
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants
- ClinicalTrials.gov ID
- NCT04503564
- Acronym / sponsor ID
- FEXIS / 150-1072-00
- Conditions
- Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes Mellitus, Insulin-Dependent, 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Capillary Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 11 Nov 2020 (actual)
- Study completion
- 11 Nov 2020 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.
Detailed description
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).
The CapBio Achilles infusion set is a sterile single use device designed to be used with commercially available infusion pumps (e.g., Medtronic MiniMed). The investigational Achilles infusion set contains a coil reinforced soft polymer indwelling cannula with one distal and three proximal holes.
The primary objective of this study is to determine feasibility and device performance of the CapBio Achilles infusion set over 2 extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion. Feasibility is evidenced by the absence of uncontrolled hyperglycemia and/or suspected infusion set cannula occlusion.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is designed as a single arm device feasibility evaluation
| Arm | Type | Receives |
|---|---|---|
| Achilles Infusion Set | Experimental | Device: coil-reinforced soft polymer indwelling cannulaCoil-reinforced soft polymer indwelling cannula |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Participant is 18 - 70 years of age inclusive
- Participant is in generally good health, as determined by the investigator
- Participant is willing and able to individually complete written informed consent and agrees to comply with all study related testing and examinations
- 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
- Participant has been diagnosed with T1DM for at least 12 months
Key exclusion criteria (30 listed)
- 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)
- Participants who routinely change their commercial insulin infusion sets twice weekly or less often (wear time greater than 3.5 days)
- 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.)
- Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
- Participant has HbA1C greater than 8.5 percent at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coil-reinforced soft polymer indwelling cannulaThis 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). | Device | Achilles Infusion Set |
Primary outcome
Rate of Infusion Set Survival at End of Day 7
Time frame: 7 days during weeks 2 and 3
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David O'Neal, M.D. principal investigator
St Vincent's Hospital Department of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coil-reinforced soft polymer indwelling cannula in people with Diabetes Mellitus, Type 1 and Type 1 Diabetes, run by Capillary Biomedical, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Infusion Set Survival at End of Day 7 (time frame: 7 days during weeks 2 and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.