Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter

Not Recruiting

Trial ID: NCT01288729

Purpose

This is an open-label cross over study looking to compare the length of infusion set wear between a teflon catheter (Quick-Set) or a steel (Sure-T) catheter.

Official Title

Duration of Infusion Set Function: A Study Comparing the Quick-Set Teflon Catheter vs Sure-T Steel Infusion Set Catheter

Stanford Investigator(s)

Bruce Buckingham
Bruce Buckingham

Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus

Eligibility


Inclusion Criteria:

   - Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump
   for at least 3 months

   - The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide
   level and antibody determinations are not needed.

   - Age 12 to 45 years

   - For females, not currently known to be pregnant

   - An understanding of and willingness to follow the protocol and sign the informed
   consent

   - Hemoglobin A1c level less than or equal to 10%

   - Medtronic Continuous subcutaneous insulin infusion pump

   - Must be able to understand spoken or written English

Exclusion Criteria:

   - Diabetic ketoacidosis in the past 6 months

   - Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months
   prior to enrollment

   - Current treatment for a seizure disorder

   - Cystic fibrosis

   - Active infection

   - A known medical condition that in the judgment of the investigator might interfere
   with the completion of the protocol such as the following examples:

   - Inpatient psychiatric treatment in the past 6 months for either the subject or the
   subject's primary care giver (i.e., parent or guardian)

   - Presence of a known adrenal disorder

   - If on antihypertensive, thyroid, anti-depressant or lipid lowering medication, lack of
   stability on the medication for the past 2 months prior to enrollment in the study

   - Abuse of alcohol

Intervention(s):

device: Sure-T Steel Infusion Set Catheter

device: Quick-Set Teflon Catheter

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Parul Patel
6507235791