Trial Outcomes & Findings for "FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM) (NCT NCT04503564)
NCT ID: NCT04503564
Last Updated: 2023-03-07
Results Overview
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.
COMPLETED
NA
20 participants
7 days during weeks 2 and 3
2023-03-07
Participant Flow
Patients were recruited from existing participant population at study center. First patient was screened at medical clinic on 11/13/19
Screening period was up to 21 days. The study comprised of Week 1 with Achilles infusion set and saline and Weeks 2 and 3 with Achilles infusion set and insulin.
Participant milestones
| Measure |
Achilles Infusion Set
Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.
|
|---|---|
|
Achilles Infusion Set w/Saline- Week 1
STARTED
|
20
|
|
Achilles Infusion Set w/Saline- Week 1
COMPLETED
|
20
|
|
Achilles Infusion Set w/Saline- Week 1
NOT COMPLETED
|
0
|
|
Achilles Infusion Set w/Insulin Week 2
STARTED
|
20
|
|
Achilles Infusion Set w/Insulin Week 2
COMPLETED
|
20
|
|
Achilles Infusion Set w/Insulin Week 2
NOT COMPLETED
|
0
|
|
Achilles Infusion Set w/Insulin Week 3
STARTED
|
20
|
|
Achilles Infusion Set w/Insulin Week 3
COMPLETED
|
20
|
|
Achilles Infusion Set w/Insulin Week 3
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
"FEXIS": (Feasibility of an Extended Wear CSII Set in Participants With T1DM)
Baseline characteristics by cohort
| Measure |
Achilles Infusion Set
n=20 Participants
Coil-reinforced soft polymer indwelling cannula
coil-reinforced soft polymer indwelling cannula: 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).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
44.3 years
STANDARD_DEVIATION 14.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
BMI
|
29.0 kg/m2
STANDARD_DEVIATION 4.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days during weeks 2 and 3Population: Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.
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.
Outcome measures
| Measure |
Achilles Infusion Set
n=41 Achilles infusion sets
Coil-reinforced soft polymer indwelling cannula: 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).
|
|---|---|
|
Rate of Infusion Set Survival at End of Day 7
|
36 Achilles infusion sets
|
Adverse Events
Achilles Infusion Set
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Achilles Infusion Set
n=20 participants at risk
Subjects used their own insulin infusion pumps from week 1 to 3. During week 1, participants wore 2 pumps. They wore their own pump (with insulin) and their own commercial infusion set and an additional study pump (with saline) and the investigational Achilles infusion set. During week 2-3, participants wore one pump. They wore their own pump (with insulin) and investigational Achilles infusion set.
|
|---|---|
|
Gastrointestinal disorders
Dental caries
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Gastrointestinal disorders
Dental Discomfort
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
General disorders
Infusion site dryness
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
General disorders
Infusion site erythema
|
25.0%
5/20 • Number of events 5 • 3 weeks
|
|
General disorders
Infusion site pain
|
10.0%
2/20 • Number of events 2 • 3 weeks
|
|
General disorders
Infusion site pruritis
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
General disorders
Infusion site reaction
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Infections and infestations
Infusion site infection
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
35.0%
7/20 • Number of events 7 • 3 weeks
|
|
Product Issues
Patient-Device Incompatibility
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
Surgical and medical procedures
Skin lesion removal
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
|
General disorders
Separation Problem
|
5.0%
1/20 • Number of events 1 • 3 weeks
|
Additional Information
Director of Clinical Affairs
Capillary BioMedical, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place