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

Stanford University

Status and phase: Completed; Phase 1

Conditions: Type 1 Diabetes

Treatments: Device: Extended Wear infusion set; Drug: Heparin; Device: Standard Infusion set

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02687256

IRB 36142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 9 patient groups

Protocol 1: Standard then Extended Set

Experimental group

Description:

Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then will repeat the cycle for a total of 4 weeks.

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 1: Extended then Standard Set

Experimental group

Description:

Participants will wear the experimental Extended Wear infusion set in combination with Heparin 400 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks.

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Sequence 1

Experimental group

Description:

Participants will wear the control (standard) infusion set for 1 week, then the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4).

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Sequence 2

Experimental group

Description:

Participants will wear the Extended Wear infusion set with heparin at 40 IU (week 1), 80 IU (week 2), 120 IU (week 3), and 200 IU (week 4), then the control (standard) infusion set (week 5).

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Sequence 3

Experimental group

Description:

Participants will wear the Extended Wear infusion set with heparin at 80 IU (week 1), 120 IU (week 2), and 200 IU (week 3), then the control (standard) infusion set (week 4), then the Extended Wear infusion set with heparin at 40 IU (week 5).

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Sequence 4

Experimental group

Description:

Participants will wear the Extended Wear infusion set with heparin at 120 IU (week 1), and 200 IU (week 2), then the control (standard) infusion set (week 3), then the Extended Wear infusion set with heparin at 40 IU (week 4), and 80 IU (week 5).

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Sequence 5

Experimental group

Description:

Participants will wear the Extended Wear infusion set with heparin at 200 IU (week 1), then the control (standard) infusion set (week 2), then the Extended Wear infusion set with heparin at 40 IU (week 3), 80 IU (week 4), and 80 IU (week 5).

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 2): Standard then Extended Set

Experimental group

Description:

Participants will wear the control (standard) infusion set for 1 week, then switch to the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then will repeat the cycle for a total of 4 weeks.

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set

Protocol 2 (Part 1): Extended then Standard Set

Experimental group

Description:

Participants will wear the experimental Extended Wear infusion set in combination with Heparin 80 IU for 1 week, then switch to the control (standard) infusion set for 1 week, then will repeat the cycle for a total of 4 weeks.

Treatment:

Device: Standard Infusion set

Drug: Heparin

Device: Extended Wear infusion set