At a glance
ClinicalIndex Comparison RecordN/ACompleted· 260 enrolled
Drug / intervention
SteadiSet Extended Wear Infusion Setdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
In Brief
A clinical study evaluating SteadiSet Extended Wear Infusion Set for Type1diabetes. Completed, enrolled 260 participants across 15 sites.
Detailed Summary
The purpose of this study is to collect clinical data to support a 7-day wear of the Extended Wear Infusion Set (EWIS). Participants will be asked to: 1. Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods 2. Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType1diabetes
CountriesUnited States
CollaboratorsJaeb Center for Health Research
Timeline
N/ACompletedFinished
20252026
First PostedFeb 2024
Enrollment StartMar 2024
Primary CompletionDec 2024
TodayJul 2026
First PostedFeb 22, 2024
Enrollment StartMar 7, 2024
Primary CompletionDec 11, 2024
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 2.4 years ago
Interventions
SteadiSet Extended Wear Infusion Setdevice
Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.