Status:
COMPLETED
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Lead Sponsor:
Capillary Biomedical, Inc.
Conditions:
Diabetes Mellitus, Type 1
Type 1 Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
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 w...
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 contin...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
November 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04503564
Start Date
November 13 2019
End Date
November 11 2020
Last Update
March 7 2023
Active Locations (1)
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1
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Melbourne, Australia