Type1diabetesNCT06273124
Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
A study testing SteadiSet Extended Wear Infusion Set in people with Type1diabetes, run by Tandem Diabetes Care, Inc. at 15 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- SteadiSet Extended Wear Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 15 sitesUnited States
- Study dates
- 7 Mar 2024to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
- NovoLog™* (insulin aspart)
- Using Humalog™ insulin lispro or NovoLog™ insulin aspart for a minimum of 1 month at the time of enrollment
- Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
- Has routine access to a smart phone e.g., ability to receive text messages
- 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)
Who cannot join
- 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
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- 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
- Currently undergoing treatment with:
- Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening),
- Thyroid hormones, unless use has been stable during the past 3 months
- Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation:
- Alcoholism
- Drug abuse
- Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results
- Current participation in another clinical drug or device study
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Barbara Davis Center
Aurora, Colorado, 80045
Texas Diabetes and Endocrinology
Austin, Texas, 78731
Massachusetts General Hospital
Boston, Massachusetts, 02114
Henry Ford Health System
Detroit, Michigan, 48202
Northwestern University
Evanston, Illinois, 60208
Rocky Mountain Clinical Research
Idaho Falls, Idaho, 83404
International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota, 55416
Icahn School of Medicine at Mt. Sinai
New York, New York, 10029
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Rainier Clinical Research Center
Renton, Washington, 98057
Mayo Clinic
Rochester, Minnesota, 55905
Endocrine Research Solutions
Roswell, Georgia, 30076
University of Washington
Seattle, Washington, 98109
Stanford University
Stanford, California, 94305
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: 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:
- Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
- Perform blood glucose and ketone measurements if continuous glucose meter is ≥250mg/dL for one hour
Read the 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
- Being tested
- SteadiSet Extended Wear Infusion Set
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteadiSet Extended Wear Infusion SetDevice
Each participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: SteadiSet Extended Wear Infusion Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start7 Mar 2024
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Responsible party
- Sponsor
- Investigators
- Alayne Lehman, RN, MS, Study director, Capillary Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06273124
- Sponsor's protocol ID
- 150-1261-00
- Status last verified
- Sep 2025
- First submitted
- 15 Feb 2024
- Last updated
- 24 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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. 2026 Jan;28(1):1-9. doi: 10.1177/15209156251364548. Epub 2025 Aug 8.
PubMed 40780817
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Single Arm, Prospective, Multicenter Study of an Investigational Extended Wear Insulin Infusion Set During Home Use in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06273124
- Acronym / sponsor ID
- 150-1261-00
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Jaeb Center for Health Research
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 22 Feb 2024 (actual)
- Results
- Posted 24 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Wear the EWIS for up to 7 consecutive days for 12 consecutive wear periods
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device Extended Wear Infusion Set Each participant will wear each extended wear infusion set for up to 168 hours for 12 sequential wear periods.
| Arm | Type | Receives |
|---|---|---|
| SteadiSet Extended Wear Infusion Set | Experimental | Device: SteadiSet Extended Wear Infusion SetEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
Key exclusion criteria (24 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SteadiSet Extended Wear Infusion SetEach participant will be given 12 Extended Wear Infusion Sets to wear over 12 wear periods up to 168 hours each. | Device | SteadiSet Extended Wear Infusion Set |
Primary outcome
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
Time frame: 12 weeks
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.
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
Time frame: 12 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40780817Lal 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. 2026 Jan;28(1):1-9. doi: 10.1177/15209156251364548. Epub 2025 Aug 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alayne Lehman, RN, MS study director
Capillary Biomedical
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SteadiSet Extended Wear Infusion Set in people with Type1diabetes, run by Tandem Diabetes Care, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06273124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025.