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

• Status: Completed
• Trial end date: 2017-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Medtronic
• Treatments: Heparin

Criteria

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