Extended Wear Insulin Infusion Set for Type 1 Diabetes

Recruiting in Palo Alto (17 mi)

+14 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Tandem Diabetes Care, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new device called the Extended Wear Infusion Set (EWIS) that helps deliver insulin for a longer period. It is aimed at adults with Type 1 diabetes who use an insulin pump. The device could make managing diabetes easier by reducing how often they need to change their infusion set. The Extended Wear Infusion Set (EWIS) is designed to improve convenience and quality of life for insulin pump users by allowing longer use compared to the standard duration.

Eligibility Criteria

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.

Inclusion Criteria

Access to internet for required periodic uploads of study device data

Has routine access to a smart phone e.g., ability to receive text messages

Living in the United States with no plans to move outside the United States during the study

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Exclusion Criteria

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

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

I am pregnant, planning to become pregnant, or not using birth control.

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Treatment Details

Interventions

SteadiSet Extended Wear Infusion Set (Insulin Delivery Device)

Trial OverviewThe 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.

Participant Groups

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.