Duration of Infusion Set Function: Quick-Set Teflon Catheter Versus Sure-T Steel Infusion Set Catheter
Trial ID or NCT#
NCT01288729
Status
NOT 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:
- * 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
Investigator(s)
Bruce Buckingham
Endocrinologist
Professor of Pediatrics (Endocrinology) at the Lucile Salter Packard Children's Hospital, Emeritus
Contact us to find out if this trial is right for you.
Contact
Parul Patel
6507235791
View on ClinicalTrials.gov
