Extended Wear Insulin Infusion Set for Type 1 Diabetes

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

260 Participants Needed

Trial Summary

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 data supports the effectiveness of the SteadiSet Extended Wear Infusion Set treatment for type 1 diabetes?

Research shows that the extended-wear insulin infusion set can be safely used for up to 7 days, maintaining good blood sugar control without major issues like leaks or severe low blood sugar. This suggests it could improve the quality of life for people using insulin pumps by reducing the frequency of changing the infusion set. ^{1 2 3 4 5}

Is the Extended Wear Insulin Infusion Set safe for humans?

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 were no serious device-related adverse events, and the set showed a high survival rate without severe complications like ketoacidosis or severe hypoglycemia. ^{1 3 4 5 6}

How is the SteadiSet Extended Wear Infusion Set different from other treatments for type 1 diabetes?

The SteadiSet Extended Wear Infusion Set is unique because it allows for longer wear time, up to 10 days, compared to the standard 2-3 days for other insulin infusion sets. This extended wear can improve convenience and quality of life for people using insulin pumps. ^{1 2 3 4 7}

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.

Research Team

Alayne Lehman, RN, MS

Principal Investigator

Capillary Biomedical

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

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Feasibility study of a prototype extended-wear insulin infusion set in adults with type 1 diabetes. [2022]

2. Poland pubmed.ncbi.nlm.nih.gov

Habits related to the use of insulin infusion set in patients with type 1 diabetes on pump therapy - the effect of the educational intervention. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Survival assessment of the extended-wear insulin infusion set featuring lantern technology in adults with type 1 diabetes by the glucose clamp technique. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Longevity of the novel ConvaTec infusion set with Lantern technology. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The improved survival rate and cost-effectiveness of a 7-day continuous subcutaneous insulin infusion set. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Prospective Study of Insulin Infusion Set Use for up to 7 Days: Early Replacement Reasons and Impact on Glycemic Control. [2022]