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

NCT ID: NCT04113694

Last Updated: 2021-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 291 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-14
• Study Completion Date: 2020-11-05

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).

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.

Conditions

Diabetes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Extended Wear Infusion Set

Each subject is given 12 Extended Wear Infusion Sets to wear.

Group Type: EXPERIMENTAL

Extended Infusion Set

Intervention Type: DEVICE

Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.

Interventions

Extended Infusion Set

Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.

Intervention Type: DEVICE

Other Intervention Names

Extended Wear Infusion Set

Eligibility Criteria

Inclusion Criteria

1. Subject is age 18 - 80 years at the time of screening

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Investigations

Little Rock, Arkansas, United States

AMCR Institute

Escondido, California, United States

Stanford University

Palo Alto, California, United States

SoCal Diabetes

West Covina, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Metabolic Research Institute

West Palm Beach, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Endocrine Research Solutions

Roswell, Georgia, United States

Iowa Diabetes and Endocrinology Center

West Des Moines, Iowa, United States

Grunberger Diabetes Institute

Bloomfield Hills, Michigan, United States

Mayo Clinic (Rochester MN)

Rochester, Minnesota, United States

Diabetes and Endocrinology Consultants of Pennsylvania

Feasterville-Trevose, Pennsylvania, United States

AM Diabetes and Endocrinology Center

Memphis, Tennessee, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Rainier Clinical Research Center

Renton, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35263188 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CEP298

Identifier Type: -

Identifier Source: org_study_id