Trial Outcomes & Findings for Longevity of Multi-Slitted Catheter With Lantern Technology (NCT NCT03819634)

NCT ID: NCT03819634

Last Updated: 2021-05-25

Results Overview

Time to when the infusion set fails and needs to be replaced.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 10 days of infusion set wear
• Results posted on: 2021-05-25

Participant Flow

Participant milestones

Measure	Lantern Infusion Set Multi-slitted lantern infusion set Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Overall Study STARTED	24
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Lantern Infusion Set Multi-slitted lantern infusion set Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Overall Study Physician Decision	2

Baseline Characteristics

Longevity of Multi-Slitted Catheter With Lantern Technology

Baseline characteristics by cohort

Measure	Lantern Infusion Set n=22 Participants Multi-slitted lantern infusion set Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Age, Continuous	40.1 years STANDARD_DEVIATION 14.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 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	3 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	0 Participants n=5 Participants
Region of Enrollment United States	22 Participants n=5 Participants
Diabetes Duration	26.4 years STANDARD_DEVIATION 12.2 • n=5 Participants
HbA1c	7.1 % glcosylated HBG:total HBG STANDARD_DEVIATION 0.8 • n=5 Participants
Total Daily Insulin Dose (Units)	48.0 units STANDARD_DEVIATION 16.7 • n=5 Participants
Body Mass Index	28.0 kg/m^2 STANDARD_DEVIATION 4.4 • n=5 Participants

PRIMARY outcome

Timeframe: 10 days of infusion set wear

Population: Participants who completed the protocol are included in the analysis.

Time to when the infusion set fails and needs to be replaced.

Outcome measures

Measure	Lantern Infusion Set n=22 Participants Multi-slitted lantern infusion set Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Time to Infusion Set Failure	8.0 days Standard Deviation 2.4

Adverse Events

Lantern Infusion Set

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lantern Infusion Set n=24 participants at risk Multi-slitted lantern infusion set Inset II with Lantern Technology: Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
Skin and subcutaneous tissue disorders subcutaneous infection	4.2% 1/24 • Number of events 1 • 10 days
Endocrine disorders hyperglycemia	25.0% 6/24 • Number of events 6 • 10 days
Endocrine disorders ketotosis	4.2% 1/24 • Number of events 1 • 10 days
Skin and subcutaneous tissue disorders adhesive failure	16.7% 4/24 • Number of events 4 • 10 days

Additional Information

Bruce Buckingham

Stanford

Phone: 6508040476

Email: buckingham@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place