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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
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