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

NCT ID: NCT02687256

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2017-11-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Protocol 1: Standard then Extended Set

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.

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 1: Extended then Standard Set

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.

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Sequence 1

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).

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Sequence 2

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).

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Sequence 3

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).

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Sequence 4

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).

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Sequence 5

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).

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 2): Standard then Extended Set

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.

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Protocol 2 (Part 1): Extended then Standard Set

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.

Group Type: EXPERIMENTAL

Extended Wear infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Standard Infusion set

Intervention Type: DEVICE

For two of the 4 weeks the Standard infusion set will be used

Heparin

Intervention Type: DRUG

Interventions

Extended Wear infusion set

For two of the 4 weeks the Extended Wear insulin infusion set will be used.

Intervention Type: DEVICE

Standard Infusion set

For two of the 4 weeks the Standard infusion set will be used

Intervention Type: DEVICE

Heparin

Intervention Type: DRUG

Other Intervention Names

Minimed

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Bruce A. Buckingham

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bruce Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB 36142

Identifier Type: -

Identifier Source: org_study_id