Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes

The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: Extended Infusion Set

Detailed Description

This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Medical Investigations
  • California
    • Escondido, California, United States, 92025
      • AMCR Institute
    • Palo Alto, California, United States, 94304
      • Stanford University
    • West Covina, California, United States, 91790
      • SoCal Diabetes
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center for Childhood Diabetes
  • Florida
    • West Palm Beach, Florida, United States, 33401
      • Metabolic Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Atlanta Diabetes Associates
    • Roswell, Georgia, United States, 30076
      • Endocrine Research Solutions
  • Iowa
    • West Des Moines, Iowa, United States, 50265
      • Iowa Diabetes and Endocrinology Center
  • Michigan
    • Bloomfield Hills, Michigan, United States, 48302
      • Grunberger Diabetes Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic (Rochester MN)
  • Pennsylvania
    • Feasterville-Trevose, Pennsylvania, United States, 19053
      • Diabetes and Endocrinology Consultants of Pennsylvania
  • Tennessee
    • Memphis, Tennessee, United States, 38133
      • AM Diabetes And Endocrinology Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject is age 18 - 80 years at the time of screening
2. Subject has type 1 diabetes for more than one year Study specific inclusion criteria
3. Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study.
4. Subject is willing and able to perform study procedures as per investigator discretion

5. Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount):

   1. Humalog™* (insulin lispro injection)
   2. NovoLog™* (insulin aspart)

Exclusion Criteria:

1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
2. Subject is female and has a positive pregnancy screening test
3. Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator
4. Subject is female and plans to become pregnant during the course of the study
5. Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

6. Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening

   1. Medical assistance (i.e. Paramedics, Emergency Room [ER] or Hospitalization)
   2. Coma
   3. Seizures
7. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
8. Subject is unable to tolerate tape adhesive in the area of infusion set
9. Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
10. Subject has infection in the area of infusion set placement at time of screening
11. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
12. Subject is currently abusing illicit drugs
13. Subject is currently abusing alcohol
14. Subject is on dialysis (for renal failure)
15. Subject has history of adrenal disorder
16. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
17. Subject has any condition that the Investigator believes would interfere with study participation
18. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
19. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
20. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
21. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
22. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
23. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
24. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended Wear Infusion Set; Each subject is given 12 Extended Wear Infusion Sets to wear.	Device: Extended Infusion Set; Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.; Other Names: Extended Wear Infusion Set

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6	Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.	144 hours
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6	Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.	144 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.	Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.	168 hours
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.	Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.	168 hours

Collaborators and Investigators

• Sponsor: Medtronic Diabetes

Publications and helpful links

General Publications

• Brazg R, Garg SK, Bhargava A, Thrasher JR, Latif K, Bode BW, Bailey TS, Horowitz BS, Cavale A, Kudva YC, Kaiserman KB, Grunberger G, Reed JC, Chattaraj S, Zhang G, Shin J, Chen V, Lee SW, Cordero TL, Rhinehart AS, Vigersky RA, Buckingham BA. Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. Diabetes Technol Ther. 2022 Aug;24(8):535-543. doi: 10.1089/dia.2021.0540. Epub 2022 Mar 24.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): November 5, 2020
• Study Completion (Actual): November 5, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 29, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CEP298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes