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

Trial ID or NCT#

NCT01288729

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 12 Years to 45 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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

Investigator(s)

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

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Contact

Parul Patel
6507235791