A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes
Authors' conclusion
The 7-day survival of the SteadiSet infusion set was very high for the primary endpoint and at an acceptable level with respect to early removal for any reason related to the device.
Study context
- Population
- Adults with T1D3,028 infusion sets
- Participants
- 260 adults
- Comparison
- SteadiSet infusion set vs prespecified survival rate of 75%
- SteadiSetn = 260
- Outcome
- Kaplan-Meier 7-day infusion set survival
- Follow-up
- 7 days
Methodological detailsindependent adjudication committee, Each set removed before 7 days adjudicated by an independent committee
- Independent adjudication committee
- Each set removed before 7 days adjudicated by an independent committee
Main finding
As reported in the abstract
Kaplan-Meier 7-day survival estimate
95%
95% CI 94% to 96%
Secondary outcomes
- Key secondary endpoint: 7-day survival with expanded reasons for failed infusion set · 7 days — Kaplan-Meier 7-day survival estimate · Kaplan-Meier 7-day survival estimate vs prespecified survival rate of 75%
- 84% (95% CI 82% to 86%) · P value was <0.001 compared with a prespecified survival rate of 75%
TIR 70-180 mg/dL · entire wear period
- Average TIR over entire wear period across all infusion sets, including failed
- 70.6%
- TIR increased through day 3 of set wear, then decreased through day 7
Total daily insulin · day 4 through day 7
- Increase in total daily insulin from day 4 through day 7
Original publication
A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes. Diabetes Technol Ther. Published 8 August 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →