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

• ClinicalTrials.gov Identifier: NCT02687256
• Recruitment Status: Completed
• First Posted: February 22, 2016
• Last Update Posted: June 6, 2018
• Sponsor: Stanford University
• Collaborator: Medtronic
• Information provided by (Responsible Party): Bruce A. Buckingham, Stanford University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes	Device: Extended Wear infusion set; Device: Standard Infusion set; Drug: Heparin	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Extended Infusion Set Wear Using the Medtronic Extended Wear Sof-set Infusion Set
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: November 2017
• Actual Study Completion Date: November 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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.	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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).	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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).	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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).	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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).	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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).	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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.	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin
Experimental: 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.	Device: Extended Wear infusion set; For two of the 4 weeks the Extended Wear insulin infusion set will be used.; Device: Standard Infusion set; For two of the 4 weeks the Standard infusion set will be used; Other Name: Minimed; Drug: Heparin

Outcome Measures

Primary Outcome Measures :

1. Time to an infusion set failure due to an occlusion [ Time Frame: within 1 week ]
   Glucose >250 mg/dL with failure of a correction dose to lower the glucose by 50 mg/dL, or ketones > or = 0.6 mg/dL with a glucose reading of >250 mg/dL (in the absence of illness), or a pump occlusion alarm

Secondary Outcome Measures :

1. signs of infection at insulin infusion site [ Time Frame: 1 week ]
   erythema or induration of > 1cm in diameter at injection site

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Stanford University

Palo Alto, California, United States, 94304

Sponsors and Collaborators

Stanford University

Medtronic

Investigators

• Principal Investigator: Bruce Buckingham, MD; Stanford University

More Information

• Responsible Party: Bruce A. Buckingham, M.D., Stanford University
• ClinicalTrials.gov Identifier: NCT02687256
• Other Study ID Numbers: IRB 36142
• First Posted: February 22, 2016
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: To maintain the integrity of this research study, the subject is told they may not have access to any health information developed as part of this study until it is completed.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

Diabetes Mellitus, Type 1; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Heparin; Anticoagulants; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action