CompletedNot Applicable

Longevity of Multi-Slitted Catheter With Lantern Technology

United States24 participantsStarted 2019-01-25

Plain-language summary

To determine time to set failure when the Convatec Inset II with Lantern technology (Convatec Lantern) infusion set with multi-slitted catheter is worn for up to 10 days

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 22 and over
. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.
. Hemoglobin A1c level less than or equal to 9%
. Eating more than 60 grams of carbohydrate each day
. For females, not currently known to be pregnant
. Understanding and willingness to follow the protocol and sign informed consent
. Willingness to wear the experimental infusion sets
. Willingness to have photographs taken of their infusion sites

Exclusion criteria

. Diabetic ketoacidosis in the past 3 months
. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months prior to enrollment
. Pregnant or lactating

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to Infusion Set Failure

Timeframe: 10 days of infusion set wear

Trial details

NCT IDNCT03819634

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-20

Results submitted2021-05-03

View on ClinicalTrials.gov More Insulin Dependent Diabetes Mellitus 1 trials