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

Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes

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 Overview

• Status: Completed
• Conditions: Type1diabetes
• Intervention / Treatment: Device: SteadiSet Extended Wear Infusion Set

Detailed Description

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
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
    • Stanford, California, United States, 94305
      • Stanford University
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55416
      • International Diabetes Center - HealthPartners Institute
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Inclusion Criteria:

  1. Age 18 to 80 years old inclusive
  2. Generally in good health, as determined by the investigator
  3. Living in the United States with no plans to move outside the United States during the study
  4. Diagnosis of T1D for at least 12 months
  5. Minimum of 6 months of insulin pump experience and at least 3 months of current experience with a Tandem pump
  6. Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment
  7. 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
  8. HbA1c <9.0% in the last 6 months.
  9. Willing to implement and adhere to pump alert/alarm settings on a study-provided pump as instructed during the study
  10. Willing to wear each investigational infusion set for up to 7 days during each of the 12 consecutive wear periods in the study
  11. Willing to perform blood ketone and blood glucose (fingerstick) measurements as directed using provided ketone and blood glucose meters and strips
  12. Access to internet for required periodic uploads of study device data
  13. BMI in the range 18-35 kg/m2, both inclusive

  14. Currently using one of the following insulins with no expectation of a need to change insulin type during the study:

      1. Humalog™* (insulin lispro)
      2. NovoLog™* (insulin aspart)
  15. Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
  16. Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
  17. Has routine access to a smart phone e.g., ability to receive text messages
  18. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., English proficient in both verbal and written communication)

Exclusion Criteria:

1. 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)
2. Female subject is pregnant, planning to become pregnant, or not using adequate method of contraception

3. Episodes of severe hypoglycemia in the last 6 months resulting in:

   1. Medical Assistance (i.e., paramedics, hospital evaluation or hospitalization)
   2. Loss of consciousness
   3. Seizures
4. One or more episodes of diabetic ketoacidosis (DKA) in the last 6 months requiring hospitalization
5. 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
6. Known cardiovascular disease considered to be clinically relevant by the investigator

7. Known history of any of the following conditions:

   1. Cushing's Disease
   2. Pancreatic islet cell tumor
   3. Insulinoma
   4. Lipodystrophy
   5. Extensive lipohypertrophy, as assessed by the investigator

8. Currently undergoing treatment with:

   1. Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
   2. Thyroid hormones, unless use has been stable during the past 3 months

9. Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:

   1. Alcoholism
   2. Drug abuse
10. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
11. Current participation in another clinical drug or device study
12. Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is a study site personnel directly affiliated with this study or who is an employee of Capillary Biomedical

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SteadiSet Extended Wear Infusion Set; 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; Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: Jaeb Center for Health Research
• Investigators: Study Director: Alayne Lehman, RN, MS, Capillary Biomedical

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 150-1261-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes