Diabetes Mellitus, Type 1NCT07325461
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
A study testing SteadiSet Infusion Set in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in United States.
Trial summary
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- SteadiSet Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2026to 24 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- 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
- Currently using a Tandem pump
- Current Dexcom CGM user
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- 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 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
- If using Tandem Mobi, has a compatible cellular phone that can run the Tandem Mobi Mobile App
- 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™ (or generic insulin lispro)
- NovoLog™ (or generic insulin aspart)
- Willing to change insulin cartridge every 48-72 hours, as recommended by patient's healthcare provider during the study
- Has the ability to understand and comply with protocol procedures and to provide informed consent
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 history of any of the following conditions:
- Cushing's Disease
- Adrenal insufficiency
- Pancreatic islet cell tumor
- Insulinoma
- Lipodystrophy
- Extensive lipohypertrophy, as assessed by the investigator
- Undergoing treatment with systemic oral or intravenous corticosteroids, at or within the last 8 weeks from screening. Inhaled glucocorticoids are allowed.
- 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 Tandem Diabetes Care
Trial locations and contacts
1 site in 1 country.
About this study
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Read the detailed description
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.
The 2 treatment arms are:
Existing t:slim X2 Users:
- t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
- t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
- Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
- Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- SteadiSet Infusion Set
- Keywords
- type 1 diabetes, T1D, Tandem, t:slim X2, Tandem Mobi, automated insulin delivery, SteadiSet
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SteadiSet Infusion SetDevice
Participants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods.
| Study group | Role | What they receive |
|---|---|---|
| t:slim X2 Users | Experimental | * t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
* t:slim X2 with and SteadiSet (43 inches) with no side ports (3 wear periods) Receives: Device: SteadiSet Infusion Set |
| Mobi Users | Experimental | * Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
* Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods) Receives: Device: SteadiSet 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
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)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start18 Feb 2026
- Primary completion24 Jun 2026
- Study completion24 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tandem Diabetes Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jordan Pinsker, MD, Study director, Tandem Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07325461
- Sponsor's protocol ID
- TP-0023728
- Status last verified
- Aug 2026
- First submitted
- 6 Jan 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07325461
- Acronym / sponsor ID
- TP-0023728
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes, T1D, Tandem, t:slim X2, Tandem Mobi, automated insulin delivery, SteadiSet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Feb 2026 (actual)
- Primary completion
- 24 Jun 2026 (actual)
- Study completion
- 24 Jun 2026 (actual)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study is a prospective, single center, multi-arm study evaluating possible enhancements to the SteadiSet extended wear infusion set.
Detailed description
All participants will use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each.
The 2 treatment arms are:
Existing t:slim X2 Users:
- t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods)
- t:slim X2 insulin pump with SteadiSet (43 inches) with no side ports (3 wear periods)
Existing Mobi Users:
- Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods)
- Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t:slim X2 Users | Experimental | Device: SteadiSet Infusion Set* t:slim X2 insulin pump with SteadiSet (43 inches) and an enhanced filling process (3 wear periods) * t:slim X2 with and SteadiSet (43 inches) with no side ports (3 wear periods) |
| Mobi Users | Experimental | Device: SteadiSet Infusion Set* Mobi Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods) * Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
- Currently using a Tandem pump
Key exclusion criteria (22 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 Infusion SetParticipants will use the SteadiSet Infusion set with an enhanced filling process for three wear periods and the Steadiset Infusion Set only for three wear periods. | Device | Mobi Users, t:slim X2 Users |
Primary outcome
7 Day Survival of Infusion Set for Primary Outcome Measure
Time frame: 6 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- 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.
Jordan Pinsker, MD study director
Tandem Diabetes Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SteadiSet Infusion Set in people with Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site 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 17 inclusion and 22 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 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.