Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
Trial ID or NCT#
NCT02687256
Status
NOT RECRUITING
Purpose
This is a blinded cross-over study to see if extended wear insulin infusion sets can prolong insulin infusion set wear up to 7 days in adults with Type 1 Diabetes.
Official Title
Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
Eligibility Criteria
Ages Eligible for Study: 18 Years to 55 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 12 months 2. The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed. 3. Age 18 to 55 years 4. Hemoglobin A1c level less than or equal to 8.5% 5. Willing to use Novolog insulin while they are participating in the study 6. Total daily insulin dose is at least 0.3 units/kg/day 7. For females, not currently known to be pregnant 8. An understanding of and willingness to follow the protocol and sign the informed consent 9. Willingness to wear the experimental insulin infusion sets throughout the study 10. Must be able to understand spoken and written English
Exclusion Criteria:
- 1. Diabetic ketoacidosis in the past 3 months 2. blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia 3. Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment 4. Pregnant or lactating females 5. Known tape allergies 6. Current treatment for a seizure disorder 7. Cystic fibrosis 8. Active infection 9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: 10. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) 11. Presence of a known adrenal disorder 12. 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 13. Abuse of alcohol 14. Dialysis for renal failure
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
Bertha deLanda, BA
650-721-6357
View on ClinicalTrials.gov
