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Insulin Delivery Device

SteadiSet Extended Wear Infusion Set for Type 1 Diabetes

N/A

Recruiting

Research Sponsored by Tandem Diabetes Care, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Using Tandem t:slim X2 insulin pump with Control-IQ technology for a minimum of 1 month at the time of enrollment

Using insulin lispro or aspart for a minimum of 3 months at the time of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 168 hours

Awards & highlights

Study Summary

This trial aims to gather data on wearing the Extended Wear Infusion Set for 7 days. Participants will wear the device for 12 periods and monitor their blood glucose and ketone levels if needed.

Who is the study for?

This trial is for people with Type 1 Diabetes who are interested in trying a new insulin infusion set designed to be worn for up to 7 days. Participants will need to wear the device over 12 consecutive periods and monitor their blood glucose, especially if it rises above certain levels.Check my eligibility

What is being tested?

The study is testing the SteadiSet Extended Wear Infusion Set's performance when worn continuously for one week. It aims to collect data on its safety and effectiveness during this extended wear time compared to standard infusion sets.See study design

What are the potential side effects?

Potential side effects may include skin irritation at the site of infusion, risk of infection, or issues with insulin delivery such as blockage that could affect blood sugar control.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been using the Tandem t:slim X2 insulin pump with Control-IQ for at least 1 month.

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I have been using insulin lispro or aspart for at least 3 months.

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I am between 18 and 80 years old.

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I have been diagnosed with Type 1 Diabetes for over a year.

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I am currently using Humalog or NovoLog insulin and don't plan to change.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 168 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~168 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 168 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure

Trial Design

1Treatment groups

Experimental Treatment

Group I: SteadiSet Extended Wear Infusion SetExperimental Treatment1 Intervention

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Jaeb Center for Health ResearchOTHER

153 Previous Clinical Trials

34,651 Total Patients Enrolled

Tandem Diabetes Care, Inc.Lead Sponsor

37 Previous Clinical Trials

5,420 Total Patients Enrolled

Alayne Lehman, RN, MSStudy DirectorCapillary Biomedical

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different geographical areas can patients access this clinical trial?

"Fifteen medical facilities, including Mayo Clinic in Rochester, University of Washington in Seattle, and Rainier Clinical Research Center in Renton among others, are actively participating in this research endeavor."

Answered by AI

What specific criteria must individuals meet to be eligible for enrollment in this clinical study?

"To be eligible for participation, individuals need to have been diagnosed with type 1 diabetes and fall within the age range of 18 to 80 years. The trial aims to enroll approximately 260 qualified candidates."

Answered by AI

Are there any available openings for patients to participate in this medical study?

"Affirmative. The details on clinicaltrials.gov indicate that this study is actively seeking participants. Originally shared on March 15, 2024, the latest update was made on February 15, 2024. This trial aims to recruit 260 individuals from a selection of 15 locations."

Answered by AI

What is the upper limit on the number of individuals enrolled in this clinical trial?

"Affirmative. The details on clinicaltrials.gov highlight that this investigation is actively in search of participants. Initially shared on March 15th, 2024, and last revised on February 15th, 2024, the study aims to enroll a total of 260 patients from fifteen locations."

Answered by AI

Is the age limit for participants in this medical study set above 30 years old?

"Eligible participants for this research must fall within the age range of 18 to 80 years. It is noteworthy that there are a total of 215 trials tailored specifically for individuals younger than 18 and 932 studies catering to those over the age of 65."

Answered by AI