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

NCT ID: NCT06273124

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-07
• Study Completion Date: 2024-12-11

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. 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

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.

Conditions

Type1diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SteadiSet Extended Wear Infusion Set

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alayne Lehman, RN, MS

Role: STUDY_DIRECTOR

Capillary Biomedical

Locations

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Stanford University

Stanford, California, United States

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

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Texas Diabetes and Endocrinology

Austin, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 40780817 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

150-1261-00

Identifier Type: -

Identifier Source: org_study_id