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
This is a multi-center, single-arm, prospective study of an extended wear infusion set in adults with Type 1 diabetes using a Tandem t:slim X2 insulin pump with Control-IQ technology with continuous Glucose Monitoring (CGM). Up to 300 participants across the United States age 18-80 will be enrolled in up to 20 investigational centers. Participants will change insulin cartridge every 48 to 72 hours as recommended by their health care provider. Participants will be expected to participate in the study for approximately 12-16 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
260
Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford University
Stanford, California, United States
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
Time frame: 12 weeks
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog.
Time frame: 12 weeks
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Barbara Davis Center
Aurora, Colorado, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Northwestern University
Evanston, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
...and 5 more locations