Trial Outcomes & Findings for Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS") (NCT NCT04398030)
NCT ID: NCT04398030
Last Updated: 2022-08-11
Results Overview
The primary endpoint will be compared between the treatment groups.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
7 days
Results posted on
2022-08-11
Participant Flow
Study participants were recruited from the existing Type 1 diabetes database at the study center and from referrals from other diabetes treatment clinics in surrounding areas.
Participant milestones
| Measure |
Coil-Reinforced Soft Polymer Indwelling Cannula Then Soft Teflon Indwelling Cannula
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.
Coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula Then Coil-Reinforced Soft Polymer Indwelling Cannula
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.
Soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Treatment Period 1 (1 Week)
STARTED
|
3
|
4
|
|
Treatment Period 1 (1 Week)
COMPLETED
|
3
|
3
|
|
Treatment Period 1 (1 Week)
NOT COMPLETED
|
0
|
1
|
|
Washout (2 Weeks)
STARTED
|
3
|
3
|
|
Washout (2 Weeks)
COMPLETED
|
3
|
3
|
|
Washout (2 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2 (1 Week)
STARTED
|
3
|
3
|
|
Treatment Period 2 (1 Week)
COMPLETED
|
2
|
3
|
|
Treatment Period 2 (1 Week)
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Coil-Reinforced Soft Polymer Indwelling Cannula Then Soft Teflon Indwelling Cannula
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.
Coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula Then Coil-Reinforced Soft Polymer Indwelling Cannula
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.
Soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Treatment Period 1 (1 Week)
Withdrawal by Subject
|
0
|
1
|
|
Treatment Period 2 (1 Week)
Physician Decision
|
1
|
0
|
Baseline Characteristics
Pharmacokinetics (PK)/ Pharmacodynamics (PD) of an Extended Wear Infusion Set for Continuous Subcutaneous Insulin Infusion (CSII) in Type 1 Diabetes Mellitus (T1DM) Patients ("PEXIS")
Baseline characteristics by cohort
| Measure |
All Study Participants
n=7 Participants
Participants were randomized to either the soft Teflon indwelling cannula group or the coil-reinforced soft polymer indwelling cannula group in treatment period 1. Then after a 2-week washout/rest (±1 week), participants crossed over into treatment period 2 using either the soft Teflon indwelling cannula or the coil-reinforced soft polymer indwelling cannula. The participant wore each infusion set up to 7 consecutive days in each treatment period.
|
|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 9.24 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
BMI
|
27.6 kg/m2
STANDARD_DEVIATION 3.81 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysPopulation: Intent to Treat (ITT) population
The primary endpoint will be compared between the treatment groups.
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
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))].
|
-0.102 Slope
Interval -0.22 to 0.016
|
-0.097 Slope
Interval -0.213 to 0.019
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
The Time-to-Maximum Glucose Infusion (GIR) rate, tmax (GIR) is the minute between the time corresponding to the GIR max and Time 0.
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
Day 0
|
65.8 min
Standard Deviation 30.07
|
67.5 min
Standard Deviation 25.05
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-Maximum Insulin Concentration (Tmax)
Day 7
|
25.0 min
Standard Deviation 7.07
|
31.0 min
Standard Deviation 16.73
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
Cmax is the maximum insulin concentration between t=0 (bolus) and t=300 minutes.
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Day 0
|
57.8 mU/L
Standard Deviation 21.51
|
62.3 mU/L
Standard Deviation 20.94
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Maximum Insulin Concentration (Cmax)
Day 7
|
86.6 mU/L
Standard Deviation 23.95
|
96.9 mU/L
Standard Deviation 49.12
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
The time to half-maximal insulin concentration- early (before peak)
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]
Day 0
|
22.8 min
Standard Deviation 11.34
|
29.1 min
Standard Deviation 10.59
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Early) Maximum Insulin Concentration [t50%(Early)]
Day 7
|
11.5 min
Standard Deviation 4.13
|
14.8 min
Standard Deviation 5.21
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
Mean residence time quantifies the sum of average absorption time and average systemic residence time.
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Day 0
|
121.8 min
Standard Deviation 25.10
|
117.7 min
Standard Deviation 27.08
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Mean-residence Time (MRT) of Insulin
Day 7
|
77.4 min
Standard Deviation 8.92
|
75.9 min
Standard Deviation 14.07
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT Population
The area under the insulin concentration curve until 300 minutes after bolus administration
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)
Day 0
|
9084 mU*min/L
Standard Deviation 2826
|
8982 mU*min/L
Standard Deviation 1453
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Area Under the Curve (AUC0-300)
Day 7
|
6920 mU*min/L
Standard Deviation 1908
|
7313 mU*min/L
Standard Deviation 2483
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
Area under the insulin concentration curve in the first 60 minutes after bolus administration
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Day 0
|
2131 mU*min/L
Standard Deviation 923.1
|
2200 mU*min/L
Standard Deviation 940.6
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Insulin Early Exposure: AUC0-60
Day 7
|
3626 mU*min/L
Standard Deviation 922.9
|
3840 mU*min/L
Standard Deviation 2055
|
SECONDARY outcome
Timeframe: 7 daysPopulation: ITT population
Time at which 50% of the maximum insulin concentration was reached.
Outcome measures
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 Participants
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=6 Participants
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)]
Day 0
|
156.8 min
Standard Deviation 34.13
|
156.5 min
Standard Deviation 44.47
|
|
Mean Differences (Within Treatments Over Time Between Day 0 and Day 7) in Time-to-50% (Late) Maximum Insulin Concentration [t50%(Late)]
Day 7
|
67.8 min
Standard Deviation 13.20
|
76.3 min
Standard Deviation 28.87
|
Adverse Events
Coil-reinforced Soft Polymer Indwelling Cannula
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Soft Teflon Indwelling Cannula
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coil-reinforced Soft Polymer Indwelling Cannula
n=6 participants at risk
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.
coil-reinforced soft polymer indwelling cannula: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
Soft Teflon Indwelling Cannula
n=7 participants at risk
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.
soft Teflon indwelling catheter: Insulin infusion set will be used for up to 7 days of continuous use or until failure
|
|---|---|---|
|
General disorders
Infusion Site Erythema
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
14.3%
1/7 • Number of events 1 • 4 weeks
|
|
General disorders
Infusion Site Induration
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
0.00%
0/7 • 4 weeks
|
|
General disorders
Infusion Site Edema
|
16.7%
1/6 • Number of events 1 • 4 weeks
|
14.3%
1/7 • Number of events 1 • 4 weeks
|
|
General disorders
Infusion Site Pain
|
16.7%
1/6 • Number of events 2 • 4 weeks
|
14.3%
1/7 • Number of events 1 • 4 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 2 • 4 weeks
|
14.3%
1/7 • Number of events 1 • 4 weeks
|
|
Product Issues
Participant-Device Interaction Incompatibility
|
16.7%
1/6 • Number of events 3 • 4 weeks
|
0.00%
0/7 • 4 weeks
|
Additional Information
Alayne Lehman Director of Clinical Affairs
Capillary BioMedical, Inc.
Phone: 949-317-1711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place