SteadiSet Infusion Set for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new infusion set, the SteadiSet Infusion Set, for individuals with Type 1 Diabetes who currently use a Tandem insulin pump. The goal is to determine if this new setup can be used longer with fewer issues. The study includes different groups to test various enhancements, such as improving the filling process or removing side ports. It suits those living in the U.S. with Type 1 Diabetes for over a year, already using a Tandem pump, and willing to follow specific pump settings and testing routines. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative diabetes management solutions.
Do I need to stop my current medications for the trial?
You may need to stop taking any non-insulin glucose-lowering medications, except for metformin. If you're using insulin, you should continue with Humalog or NovoLog without changing the type during the study.
What prior data suggests that the SteadiSet Infusion Set is safe for Type 1 Diabetes?
Research has shown that the SteadiSet Infusion Set, when used with the t:slim X2 insulin pump, is as safe as other insulin delivery systems. This infusion set delivers insulin just under the skin. Disconnecting the pump before certain medical procedures, like MRI scans, is important to avoid any risks.
For the Mobi Insulin Pump with the SteadiSet, studies have examined the safety of wearing it for extended periods. The infusion set is designed for single use and has been tested to work effectively for up to 7 days in people with Type 1 diabetes, suggesting it is generally well-tolerated during this time.
While these devices are generally safe, users should know how to use them correctly. Incorrectly filling the tubing can lead to excessive insulin delivery, which can be dangerous. Always follow the instructions from healthcare professionals to use the device safely and effectively.12345Why are researchers excited about this trial?
Researchers are excited about the SteadiSet Infusion Set for Type 1 Diabetes because it introduces a new approach to insulin delivery. Unlike traditional infusion sets that might require more frequent changes and complex filling processes, the SteadiSet offers an enhanced filling process aimed at improving convenience and user experience. Additionally, the SteadiSet comes in varying lengths, like 43 inches for the t:slim X2 insulin pump users and 5 inches for Mobi insulin pump users, catering to different user needs and preferences. These improvements could potentially lead to better adherence to insulin therapy and improved blood glucose management for individuals with Type 1 Diabetes.
What evidence suggests that the SteadiSet Infusion Set is effective for Type 1 Diabetes?
This trial will compare the SteadiSet infusion set with two different insulin pumps. Research has shown that the SteadiSet infusion set, when paired with the t:slim X2 insulin pump, effectively manages blood sugar levels in people with Type 1 diabetes. Users experienced good blood sugar control from day 4 to day 7, with a slight increase in daily insulin use. Studies have also shown that this system maintains stable blood sugar levels without causing severe low blood sugar episodes.
For participants using the Mobi Insulin Pump with the SteadiSet infusion set, research suggests that the infusion set performs well for up to 7 days. An increase in insulin use from day 4 to day 7 indicates that the set can maintain blood sugar control over longer periods. Both systems aim to make insulin therapy more convenient and effective for managing diabetes.15678Who Is on the Research Team?
Jordan Pinsker, MD
Principal Investigator
Tandem Diabetes Care
Are You a Good Fit for This Trial?
This trial is for people aged 18-80 with Type 1 Diabetes who are in good health and live in the US. They must have had diabetes for at least a year, use a Tandem pump and Dexcom CGM, have an HbA1c below 9% in the past six months, and be willing to follow study procedures using provided devices.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the SteadiSet insulin infusion set for 6 wear periods of up to 7 days each
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SteadiSet Infusion Set
Trial Overview
The study is testing potential improvements to the SteadiSet extended wear infusion set used by people with Type 1 Diabetes. Participants will try out different versions of this infusion set during their regular home routines.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
* 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 Insulin Pump with SteadiSet (5 inches) and an enhanced filling process (3 wear periods) * Mobi Insulin Pump and SteadiSet (5 inches) (3 wear periods)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tandem Diabetes Care, Inc.
Lead Sponsor
Citations
Feasibility Study of Extended Wear Insulin Infusion Set ...
Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes ... Mobi Insulin Pump and SteadiSet ...
A Multicenter Study of an Investigational Extended Wear ...
An increase in total daily insulin was observed from day 4 through day 7. Conclusions: The 7-day survival of the SteadiSet infusion set was very ...
SteadiSet Infusion Set for Type 1 Diabetes
The study is testing potential improvements to the SteadiSet extended wear infusion set used by people with Type 1 Diabetes. Participants will try out different ...
Quarter 2 Diabetes Technology Update – August 2025
The 7-day Steadiset infusion set and the Mobi Tubeless pump (with built-in 7-day Steadiset) are expected in 2026 (in the US). Although off- ...
Investigational Extended Wear Insulin Infusion Set in ...
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.
Tandem Mobi System with Control-IQ Technology
Indications for use, system warnings and precautions, potential benefits and risks, and more safety information for the Tandem Mobi System with Control-IQ ...
A 510(k) Number K242692 B Applicant Capi
The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.
Insulin Pump Infusion Sets | Tandem Diabetes Care
These infusion sets are indicated for single use. For contraindications, warnings, precautions, and other important information, please refer to the ...
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