Extended Wear Insulin Infusion Set for Type 1 Diabetes

No longer recruiting at 14 trial locations

Overseen By Camilla Levister, MS, ANCP-C

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tandem Diabetes Care, Inc.

Must be taking: Insulin

Must not be taking: Non-insulin glucose-lowering

Disqualifiers: Pregnancy, Severe hypoglycemia, DKA, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12-16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new insulin infusion set, designed to be worn for up to 7 days, to ease life for people with Type 1 Diabetes. The researchers aim to determine if the SteadiSet Extended Wear Infusion Set functions well with current glucose monitors and insulin pumps. Participants should have had Type 1 Diabetes for at least a year, use a Tandem insulin pump, and be comfortable with regular blood glucose checks. Those who meet these criteria and wish to explore a longer-lasting insulin infusion option may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to innovative diabetes care solutions.

Do I need to stop my current medications to join the trial?

The trial does not specify that you need to stop taking your current medications, but you cannot use any non-insulin glucose-lowering agents other than metformin. You must continue using either Humalog or NovoLog insulin.

What prior data suggests that this infusion set is safe for extended wear?

Research has shown that the SteadiSet Extended Wear Infusion Set is generally safe for adults with Type 1 diabetes. Studies found it can be used continuously for up to 7 days without major problems. Participants reported it was comfortable, and no serious side effects were directly linked to the infusion set. Some users experienced minor skin irritation, a common issue with all infusion sets, not just the SteadiSet. The evidence suggests this infusion set is a safe choice for managing insulin delivery over an extended period. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SteadiSet Extended Wear Infusion Set is unique because it offers a longer wear time compared to standard insulin infusion sets, which typically need to be replaced every few days. This new infusion set allows for up to 168 hours of continuous wear, reducing the frequency of changes and potentially increasing convenience and comfort for individuals with Type 1 diabetes. Researchers are excited because this could lead to better adherence to insulin therapy and improved blood sugar control, while also lowering the risk of skin irritation and infection associated with frequent set changes.

What evidence suggests that the Extended Wear Infusion Set is effective for Type 1 Diabetes?

Research has shown that the SteadiSet Extended Wear Infusion Set, which participants in this trial will use, is safe for up to 7 days for people with Type 1 diabetes. Studies have found that it functions well throughout this period without needing replacement. Users have successfully managed their blood sugar levels. From day 4 to day 7, daily insulin use slightly increased, but overall, it effectively managed diabetes. This suggests that the SteadiSet is a promising choice for those who prefer less frequent infusion set changes. ^{1 2 3 4 5}

Who Is on the Research Team?

Alayne Lehman, RN, MS

Principal Investigator

Capillary Biomedical

Are You a Good Fit for This Trial?

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

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the Extended Wear Infusion Set for up to 7 consecutive days for 12 consecutive wear periods

12-16 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SteadiSet Extended Wear Infusion Set

Trial Overview 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.

How Is the Trial Designed?

Group I: SteadiSet Extended Wear Infusion Set Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Tandem Diabetes Care, Inc.

Lead Sponsor

Trials

43

Recruited

5,800+

Jaeb Center for Health Research

Collaborator

Trials

162

Recruited

36,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06273124

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.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40780817/

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04591925

NCT04591925 | SteadiSet™ Pilot Study (SteP Study) This study will evaluate the safety and effectiveness of how well blood glucose is managed when a participate wears the investigational SteadiSet™ Infusion ...

4. liebertpub.com liebertpub.com/doi/abs/10.1177/15209156251364548

A Multicenter Study of an Investigational Extended Wear ... Conclusions: The 7-day survival of the SteadiSet infusion set was very high for the primary endpoint and at an acceptable level with respect to ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-2-2024-a2e48

Extended Wear Insulin Infusion Set for Type 1 Diabetes The Extended Wear Insulin Infusion Set has been tested in adults with type 1 diabetes and found to be generally safe for up to 7 days of use. In studies, there ...