None listed
Conditions
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.
Interventions
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 i
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. Secondary objectives include the assessment of standard glucose control measures obtained from CGM, including observed hyper- and hypoglycemic episodes, patient tolerability (patient comfort) during wear period, cannula dislodgment, inability to pierce skin or leakage, and adverse events (infusion site reaction/infection, etc.). Regarding Week 1, patient comfort, cannula dislodgment, inability to pierce skin or leakage, and adverse events such as infusion site reactions/infections, etc. are secondary outcomes of this study. All staff on the study will be trained on the study and associated procedures prior to undertaking any study related activities. A principal investigator with adequate medical training will oversee the study procedures associated with the trial. A dedicated study coordinator will assist with the day to day activities of the study. The existing patient population at the study center will be screened for study eligibility within 21 days of planned study enrollment Eligible participants will complete written informed consent and be assigned a study identifier. The study is comprised of 3 periods. Each period is initiated at the study center and followed by a home-use phase of up to 7 days: During home-use periods, participants will conduct daily visual infusion site inspection and record pain levels and skin reactions. They will use Dexcom G5 Continuous Glucose Monitor (CGM) (if patient is not routinely using this CGM) to monitor blood glucose and detect hypo and or hyperglycemic episodes or events. If participant experiences an Achilles infusion set device issue, participants shall insert a commercial CSII set to maintain routine insulin therapy. Participants will be provided with training and written instructions if an Achilles device issue occurs at any time during home wear periods. They are instructed to contact study staff as early as possible after infusion set failure and return to the study site at their earliest convenience. 1. Week 1 (t equals 7 days): Trial run with saline infusion. Patients will continue to use their own pump and insulin infusion set while wearing the CapBio Achilles infusion set connected to a second pump. The reservoir in this pump will be filled with saline and patients will mimic their insulin basal/bolus pattern on the dummy pump. 2. Week 2 (t equal to or less than 7 days): After successful completion of Week 1, patients will manage their blood glucose (BG) solely with their insulin pump and the Achilles infusion set. BG will be closely monitored with a continuous glucose monitoring (CGM) device. Week 2 is considered complete when either, (1) an Achilles infusion set failure (see below) occurs and participant needs to insert a commercial CSII set to maintain routine therapy until they return to the study center, or (2) participant has worn Achilles for the total 7-day wear period. 3. Week 3 (t equal to or less than 7 days): (Note: Initiation of Week 3 will only occur if Week 2 was completed without any major safety issues, adverse events or other concerns.) After completion of Week 2 patients will return to study center to receive a fresh Achilles infusion set and continue BG management with at home until infusion set failure (see below). BG will be closely monitored with a continuous glucose monitoring (CGM) device. Week 3 is considered complete when either, (1) an Achilles infusion set failure occurs and participant needs to insert a commercial CSII set to maintain routine therapy until they return to the study center, or (2) participant has worn Achilles for the total 7-day wear period. Infusion set failure is defined as: 1. The occurrence of unexplained hyperglycemia (glucose greater than 250 mg per dL or greater than 14 mmol per L) occurring more than 2 hours after a meal and not responsive to a pump bolus dose where response to the bolus is defined as a fall of at least 50 mg per dL (3 mmol per L) in blood glucose within one hour 2. The occurrence of any hyperglycemic episode (glucose greater than 250 mg per dL or greater than 14 mmol per L) not associated with acute intercurrent illness, but with a concurrent ketone level equal to or greater than 0.6 mmol per L. 3. Signs of infection (e.g. erythema or induration greater than 1 cm in maximal diameter), 4. Occurrence of non-resolvable insulin pump occlusion alarm signal.
Sponsors
Capillary Biomedical, Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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: a) Cushing’s Disease, b) pancreatic islet cell tumor, or c) insulinoma 11) Participant has: a) Lipodystrophy, b) extensive lipohypertrophy, as assessed by the investigator 12) Participant is undergoing current treatment with: a) Systemic oral or intravenous corticosteroids, b) monoamine oxidase (MAO) inhibitors, c) non-selective beta-blockers, d) growth hormone, e) 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: a) Alcoholism, b) 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
Outcome results
None listed