Longevity of Multi-Slitted Catheter With Lantern Technology

Completed · Not applicable

Conditions studied: Insulin Dependent Diabetes Mellitus 1

In brief

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

Key facts

Study ID

NCT03819634

Run by

Stanford University

People needed

24

Starts

2019-01-25

Expected to finish

2019-04-20

Last updated by the study team

2021-05-25

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 Diabetes by clinical definition
• 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
• Ability to speak, read and write in the language of the investigators

You may not qualify if…

• The presence of any of the following is an exclusion for the study:
• 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
• Known adrenal disorder
• Current treatment for a seizure disorder
• Inpatient psychiatric treatment in the past 6 months
• Lack of stability on medication 1 month prior to enrollment including antihypertensive, thyroid, anti-depressant or lipid lowering medication.
• Use of SGLT inhibitor
• Suspected drug or alcohol abuse
• Dialysis or end stage kidney disease
• Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

Where it is running

• Stanford — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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