Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1, Type 1 Diabetes

In brief

This study has been designed as a prospectively enrolled, randomized sequence, 2-way crossover study of device performance, tolerability and safety of an investigational insulin infusion set using a coil-reinforced soft polymer indwelling cannula versus a commercial insulin infusion set using a soft Teflon indwelling cannula, during two 7-day home use periods with 4 in-clinic euglycemic clamp sessions during each of the 7-day periods. After a wash-out period, subjects will cross over into the investigational or control group, respectively.

Key facts

Study ID

NCT04398030

Run by

Capillary Biomedical, Inc.

People needed

7

Starts

2020-07-17

Expected to finish

2021-04-22

Last updated by the study team

2022-08-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Participants are 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 <0.6 nmol/L at screening
• Participant has been using insulin pump therapy for at least 6 months and is currently using a Medtronic MiniMed pump, model series 530 or higher. Use of 670G in auto mode is acceptable.
• Participant can provide a minimum of 14 days of insulin pump data to demonstrate pump use compliance
• Participant is willing to perform frequent (4 times per day or more) self-monitoring of blood glucose (SMBG), including before meals and before bed, and using a meter and test strips provided by the sponsor during the two weeks of active treatment. This includes participants who are currently using real-time continuous glucose monitoring and may continue to do so, but must also collect SMBG values as instructed.
• Participant is willing to perform serum ketone measurements whenever the blood glucose is determined to be greater than 250 mg/dL after extended fasting (e.g. overnight or more than five hours after a meal) using a ketone meter and strips provided by the sponsor
• Participant has BMI in the range 20 - 35 kg/m2 inclusive
• Participant has experience infusing a rapid-acting insulin analog for at least 6 months
• Participant has been using or is willing to use a Continuous Glucose Monitor (CGM) (reading data available for at least 80% of time for a week of data collection during the screening period). Participants already using - Dexcom G6 real time CGM may continue to use their own CGM unit; participants not using the G6 will be provided with a G6 monitor. All participants will be provided with CGM disposables for use during the treatment period.
• Participant has ability to understand and comply with protocol procedures and to provide informed consent
• HbA1c ≤8.5%
• Stable body weight in the 3 months prior to enrollment (change in body weight <5%)

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Participants whose average total daily insulin dose exceeds 85 units/day (i.e., typically change insulin reservoirs more often than every 4 days on average)
• Participants who routinely change their commercial insulin infusion sets on average less often than every 4.5 days
• Female participant is pregnant or nursing
• Participant has abnormal skin at intended device infusion sites (existing infection, inflammation, burns, or other extensive scarring)
• Participant has hemoglobin <12.0 g/dL or potassium < 3.5 milliequivalent/L 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 systemic beta-blockers,
• Growth hormone,
• Thyroid hormones, unless use has been stable during the past 3 months
• SGLT2 inhibitors
• Participant has significant history of any of the following, that in the opinion of the investigator would compromise the participant's safety or successful study participation:

Where it is running

• AMCR Institute — Escondido, California, United States

Full record on ClinicalTrials.gov

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