Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes

NCT06273124 | Completed Results DMC FDA Device

• 1 other identifier: 150-1261-00
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 15

Brief 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. 1.Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
2. 2.Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Study Arms (1)

SteadiSet Extended Wear Infusion Set

EXPERIMENTAL

Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.

Device: SteadiSet Extended Wear Infusion Set

Interventions

SteadiSet Extended Wear Infusion Set DEVICE

Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.

SteadiSet Extended Wear Infusion Set

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80 years old inclusive
• Generally in good health, as determined by the investigator
• Living in the United States with no plans to move outside the United States during the study
• Diagnosis of T1D for at least 12 months
• Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
• Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
• Minimum of 14 days of Control-IQ data immediately preceding screening that demonstrate pump use compliance, including at least 85% of time with Control-IQ technology active
• HbA1c \<9.0% in the last 6 months.
• Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
• Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study
• Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
• Access to internet for required periodic uploads of study device data
• BMI in the range 18-35 kg/m2, both inclusive
• Currently using one of the following insulins with no expectation of a need to change insulin type during the study:
• Humalog™\* (insulin lispro)

You may not qualify if:

• Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
• Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception
• Episodes of severe hypoglycemia in the last 6 months resulting in:
• Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
• Loss of consciousness
• Seizures
• One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
• Currently on a ketogenic or low-carbohydrate diet of less than 60 grams of carbohydrates per day, or intending to begin one during the study period
• Known cardiovascular disease considered to be clinically relevant by the investigator
• Known history of any of the following conditions:
• Cushing's Disease
• Pancreatic islet cell tumor
• Insulinoma
• Lipodystrophy
• Extensive lipohypertrophy, as assessed by the investigator

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (15)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

International Diabetes Center - HealthPartners Institute

Minneapolis, Minnesota, 55416, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Lal RA, Lum JW, Reed ZW, Kruger D, Reed JC 3rd, Weinstock RS, Carlson AL, Kudva YC, Liljenquist D, Cobry EC, Levister CM, Aleppo G, Chen J, Ahn DT, Hirsch IB, Putman MS, Broyles F, Pinsker JE, Romey M, Lehman A, Muchmore DB, Kollman C, Beck RW; CB1 Study Group. A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2025 Aug 8. doi: 10.1177/15209156251364548. Online ahead of print.

  PMID: 40780817 RESULT

Results Point of Contact

• Title: Supervisor, Clinical Operations
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

(858) 366-6900

Study Officials

• Alayne Lehman, RN, MS

  Capillary Biomedical

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: March 7, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: September 24, 2025
• Results First Posted: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)