- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04503564
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM) (FEXIS)
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Melbourne, Australia
- St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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.
- 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 -
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Achilles Infusion Set
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Infusion Set Survival at End of Day 7
Time Frame: 7 days during weeks 2 and 3
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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.
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7 days during weeks 2 and 3
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BG control
Time Frame: Week 2 and week 3
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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. |
Week 2 and week 3
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Tolerability: VAS (Visual Analog Scale)
Time Frame: Week 1, Week 2 and Week 3
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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
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Week 1, Week 2 and Week 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David O'Neal, M.D., St Vincent's Hospital Department of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 150-1072-00
- ACTRN12620000021976 (Registry Identifier: ANZCTR (Australian New Zealand Clinical Trials Registry)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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