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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Drug: Heparin; Device: Extended Wear infusion set; Device: Standard Infusion set

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / 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.	Drug: Heparin; 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 Names: Minimed
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.	Drug: Heparin; 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 Names: Minimed
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).	Drug: Heparin; 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 Names: Minimed
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).	Drug: Heparin; 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 Names: Minimed
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).	Drug: Heparin; 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 Names: Minimed
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).	Drug: Heparin; 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 Names: Minimed
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).	Drug: Heparin; 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 Names: Minimed
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.	Drug: Heparin; 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 Names: Minimed
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.	Drug: Heparin; 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 Names: Minimed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to an infusion set failure due to an occlusion	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	within 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
signs of infection at insulin infusion site	erythema or induration of > 1cm in diameter at injection site	1 week

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Actual): November 1, 2017
• Study Completion (Actual): November 1, 2017

Study Registration Dates

• First Submitted: February 9, 2016
• First Submitted That Met QC Criteria: February 19, 2016
• First Posted (Estimate): February 22, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 1, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: IRB 36142

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes