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

NCT04398030 | Completed Results FDA Device

• 2 other identifiers: 150-1022-002R44DK110969-02
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 1; Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• The Primary Endpoint is the Rate of Decline (s) Over Wear Time (DOI, Day 3, Day 5, Day 7) of the Natural Logarithm of the Area Under the Glucose Infusion Rate Curve [ln (AUC0-300(GIR))].

  The primary endpoint will be compared between the treatment groups.

  7 days

Secondary Outcomes (7)

• Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)

  7 days

• Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)

  7 days

• Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]

  7 days

• Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin

  7 days

• Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)

  7 days

Study Arms (2)

coil-reinforced soft polymer indwelling cannula

EXPERIMENTAL

Participants in this arm are randomized into the coil-reinforced soft polymer indwelling cannula group and then switched to a soft Teflon indwelling cannula group after a 2-week washout/rest (±1 week). The participant will try to wear each infusion set for 7 consecutive days.

Device: coil-reinforced soft polymer indwelling cannula

soft Teflon indwelling cannula

ACTIVE COMPARATOR

Participants in this arm are randomized into the soft Teflon indwelling cannula group and then switched to the coil-reinforced soft polymer indwelling cannula group after a 2-week washout/rest (±1 week). The participant will try to wear each infusion set for 7 consecutive days.

Device: soft Teflon indwelling catheter

Interventions

coil-reinforced soft polymer indwelling cannula DEVICE

Insulin infusion set will be used for up to 7 days of continuous use or until failure

coil-reinforced soft polymer indwelling cannula

soft Teflon indwelling catheter DEVICE

Insulin infusion set will be used for up to 7 days of continuous use or until failure

soft Teflon indwelling cannula

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

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:

Sponsors & Collaborators

• Capillary Biomedical, Inc.: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• AMCR Institute: collaborator
• Integrated Medical Development: collaborator

Study Sites (1)

AMCR Institute

Escondido, California, 92025, United States

Location

Related Publications (1)

• Kastner JR, Bailey TS, Strange P, Shi L, Oberg KA, Strasma PJ, Joseph JI, Muchmore DB. Progressive Acceleration of Insulin Exposure Over 7 Days of Infusion Set Wear. Diabetes Technol Ther. 2023 Feb;25(2):143-147. doi: 10.1089/dia.2022.0323. Epub 2022 Dec 20.

  PMID: 36342853 DERIVED

Related Links

• Site link which allows for the participant to enter information for the site to identify possible studies for participant enrollment

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Alayne Lehman Director of Clinical Affairs
• Organization: Capillary BioMedical, Inc.

alayne.lehman@capillarybio.com

949-317-1711

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 21, 2020
• Study Start: July 17, 2020
• Primary Completion: April 22, 2021
• Study Completion: April 22, 2021
• Last Updated: August 11, 2022
• Results First Posted: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)