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 range22 Years

SexALL

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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
✕. Known tape allergies
✕. Active infection
✕. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol
✕. Known cardiovascular events in the last 6 months
✕. Known acute proliferative diabetic retinopathy

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