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

April 23, 2024 updated by: Tandem Diabetes Care, Inc.

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

260

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Memorial Hospital Presbyterian
        • Principal Investigator:
          • David Ahn, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Not yet recruiting
        • Stanford University
        • Principal Investigator:
          • Rayhan Lal, MD
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Not yet recruiting
        • Barbara Davis Center
        • Principal Investigator:
          • Erin Cobry, MD
        • Contact:
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Endocrine Research Solutions
        • Contact:
        • Principal Investigator:
          • John C Reed, MD
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Not yet recruiting
        • Rocky Mountain Clinical Research
        • Principal Investigator:
          • David Liljenquist, MD
        • Contact:
    • Illinois
      • Evanston, Illinois, United States, 60208
        • Not yet recruiting
        • Northwestern University
        • Principal Investigator:
          • Grazia Aleppo, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Melissa Putman, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Not yet recruiting
        • Henry Ford Health System
        • Contact:
        • Principal Investigator:
          • Davida Kruger, NP
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • Not yet recruiting
        • International Diabetes Center - HealthPartners Institute
        • Principal Investigator:
          • Richard Bergenstal, MD
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Not yet recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Yogish Kudva, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Not yet recruiting
        • Icahn School of Medicine at Mt. Sinai
        • Contact:
        • Principal Investigator:
          • Camilla Levister, MS, ANCP-C
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Contact:
        • Principal Investigator:
          • Ruth Weinstock, MD
    • Texas
      • Austin, Texas, United States, 78731
        • Not yet recruiting
        • Texas Diabetes and Endocrinology
        • Principal Investigator:
          • Jean Chen, MD
        • Contact:
    • Washington
      • Renton, Washington, United States, 98057
        • Not yet recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Frances Broyles, MD
        • Contact:
      • Seattle, Washington, United States, 98109
        • Not yet recruiting
        • University of Washington
        • Contact:
          • Dori Khakpour
          • Phone Number: 206-945-4965
          • Email: dorik@uw.edu
        • Principal Investigator:
          • Irl Hirsch, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Primary Outcome Measure
Time Frame: 168 hours
Rate of infusion set failure at the end of 7 days in participants taking Novolog
168 hours
Primary Outcome
Time Frame: 168 hours
Rate of infusion set failure at the end of 7 days in participants taking Humalog
168 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tandem Diabetes Care, Inc.

Collaborators

Jaeb Center for Health Research

Investigators

  • Study Director: Alayne Lehman, RN, MS, Capillary Biomedical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 7, 2024

Primary Completion (Estimated)

January 15, 2025

Study Completion (Estimated)

January 15, 2025

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 (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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