FEXIS: (Feasibility of an Extended Wear CSII Set in Participants With T1DM)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Feasibility of an Investigational Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Participants

Conditions
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Diabetes Mellitus, Type 1, Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes Mellitus, Insulin-Dependent, 1

Intervention / Treatment
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* Device: coil-reinforced soft polymer indwelling cannula


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: This study is designed as a single arm device feasibility evaluation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Achilles Infusion Set<br>Coil-reinforced soft polymer indwelling cannula | Device: coil-reinforced soft polymer indwelling cannula<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days during weeks 2 and 3 |