Status:
COMPLETED
Longevity of Multi-Slitted Catheter With Lantern Technology
Lead Sponsor:
Stanford University
Collaborating Sponsors:
ConvaTec Inc.
Conditions:
Insulin Dependent Diabetes Mellitus 1
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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
Detailed Description
This is a pilot study to obtain preliminary data to determine the time to set failure when the Lantern infusion set is worn for up to 10 days. The study is not intended for registration purposes or to...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03819634
Start Date
January 25 2019
End Date
April 20 2019
Last Update
May 25 2021
Active Locations (1)
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1
Stanford
Palo Alto, California, United States, 94305