Clinical trial NCT02687256: Evaluation of Extended Infusion Set Wear Using Medtronic Extended Wear Sof-set Infusion Set
Official title: Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 1 Diabetes
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-02-22
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a double blinded cross-over study. Subjects will be asked to wear infusion set either a standard infusion set or an extended wear infusion set. They will wear each infusion set twice, and the order of infusion set wear will be randomized with the first infusion set wear and then alternated over 4 weeks. By performing a cross over study using both experimental infusion sets and standard infusion sets, the investigators hope to see whether there is a benefit to using an extended wear infusion set.

Eligibility 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

Primary outcomes:
measure: Time to an infusion set failure due to an occlusion
timeFrame: within 1 week
Secondary outcomes:
measure: signs of infection at insulin infusion site
timeFrame: 1 week
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Bruce Buckingham, MD
role: PRINCIPAL_INVESTIGATOR
References: