Trial Search Results

Longevity of Multi-Slitted Catheter With Lantern Technology

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: ConvaTec Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Inset II with Lantern Technology

Phase:

N/A

Eligibility


Inclusion Criteria:

Type 1 Diabetes by clinical definition

   1. Age 22 and over

   2. On tethered insulin pump therapy for at least 3 months using Lispro or Aspart insulin.

   3. Hemoglobin A1c level less than or equal to 9%

   4. Eating more than 60 grams of carbohydrate each day

   5. For females, not currently known to be pregnant

   6. Understanding and willingness to follow the protocol and sign informed consent

   7. Willingness to wear the experimental infusion sets

   8. Willingness to have photographs taken of their infusion sites

   9. Ability to speak, read and write in the language of the investigators

Exclusion Criteria:

The presence of any of the following is an exclusion for the study:

   1. Diabetic ketoacidosis in the past 3 months

   2. Severe hypoglycemia resulting in seizure or loss of consciousness within 3 months
   prior to enrollment

   3. Pregnant or lactating

   4. Known tape allergies

   5. Active infection

   6. A known medical condition that in the judgment of the investigator might interfere
   with the completion of the protocol

   7. Known cardiovascular events in the last 6 months

   8. Known acute proliferative diabetic retinopathy

   9. Known adrenal disorder

10. Current treatment for a seizure disorder

11. Inpatient psychiatric treatment in the past 6 months

12. Lack of stability on medication 1 month prior to enrollment including
   antihypertensive, thyroid, anti-depressant or lipid lowering medication.

13. Use of SGLT inhibitor

14. Suspected drug or alcohol abuse

15. Dialysis or end stage kidney disease

Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from
enrollment.

Ages Eligible for Study

22 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Liana Hsu, BS
650-725-3939
Not Recruiting