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

• ClinicalTrials.gov Identifier: NCT04113694
• Recruitment Status: Completed
• First Posted: October 3, 2019
• Results First Posted: October 1, 2021
• Last Update Posted: October 1, 2021
• Sponsor: Medtronic Diabetes
• Information provided by (Responsible Party): Medtronic Diabetes

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diabetes	Device: Extended Infusion Set	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 291 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
• Actual Study Start Date: October 14, 2019
• Actual Primary Completion Date: November 5, 2020
• Actual Study Completion Date: November 5, 2020

Arms and Interventions

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 Name: Extended Wear Infusion Set

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Arkansas

Medical Investigations

Little Rock, Arkansas, United States, 72205

United States, California

AMCR Institute

Escondido, California, United States, 92025

Stanford University

Palo Alto, California, United States, 94304

SoCal Diabetes

West Covina, California, United States, 91790

United States, Colorado

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States, 80045

United States, Florida

Metabolic Research Institute

West Palm Beach, Florida, United States, 33401

United States, Georgia

Atlanta Diabetes Associates

Atlanta, Georgia, United States, 30318

Endocrine Research Solutions

Roswell, Georgia, United States, 30076

United States, Iowa

Iowa Diabetes and Endocrinology Center

West Des Moines, Iowa, United States, 50265

United States, Michigan

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, United States, 48302

United States, Minnesota

Mayo Clinic (Rochester MN)

Rochester, Minnesota, United States, 55905

United States, Pennsylvania

Diabetes and Endocrinology Consultants of Pennsylvania

Feasterville-Trevose, Pennsylvania, United States, 19053

United States, Tennessee

AM Diabetes and Endocrinology Center

Memphis, Tennessee, United States, 38133

United States, Virginia

University of Virginia Health System

Charlottesville, Virginia, United States, 22908

United States, Washington

Rainier Clinical Research Center

Renton, Washington, United States, 98057

Sponsors and Collaborators

Medtronic Diabetes

  Study Documents (Full-Text)

Documents provided by Medtronic Diabetes:

Study Protocol  [PDF] September 25, 2019

Statistical Analysis Plan  [PDF] November 19, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Mar 24. doi: 10.1089/dia.2021.0540. [Epub ahead of print]

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT04113694
• Other Study ID Numbers: CEP298
• First Posted: October 3, 2019
• Results First Posted: October 1, 2021
• Last Update Posted: October 1, 2021
• Last Verified: September 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Additional relevant MeSH terms:

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases