Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set

Completed · Phase 1

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02687256

Run by

Stanford University

People needed

24

Starts

2016-03-01

Expected to finish

2017-11-01

Last updated by the study team

2018-06-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes for at least one year and using an insulin pump for at least 12 months
• The diagnosis of type 1 diabetes is based on the investigator's judgment; C-peptide level and antibody determinations are not needed.
• Age 18 to 55 years
• Hemoglobin A1c level less than or equal to 8.5%
• Willing to use Novolog insulin while they are participating in the study
• Total daily insulin dose is at least 0.3 units/kg/day
• For females, not currently known to be pregnant
• An understanding of and willingness to follow the protocol and sign the informed consent
• Willingness to wear the experimental insulin infusion sets throughout the study
• Must be able to understand spoken and written English

You may not qualify if…

• Diabetic ketoacidosis in the past 3 months
• blood urea nitrogen (BUN), Creatinine, or liver function test (ALT or AST) more than three times the upper limit of normal, or thrombocytopenia
• Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
• Pregnant or lactating females
• Known tape allergies
• 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
• Dialysis for renal failure

Where it is running

• Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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