Clinical trial NCT04113694: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Official title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2019-10-03
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6
timeFrame: 144 hours
measure: Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6
timeFrame: 144 hours
Secondary outcomes:
measure: Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
timeFrame: 168 hours
measure: Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
timeFrame: 168 hours
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Medical Investigations
state: Arkansas
city: Escondido
country: United States
facility: AMCR Institute
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: West Covina
country: United States
facility: SoCal Diabetes
state: California
city: Aurora
country: United States
facility: Barbara Davis Center for Childhood Diabetes
state: Colorado
city: West Palm Beach
country: United States
facility: Metabolic Research Institute
state: Florida
city: Atlanta
country: United States
facility: Atlanta Diabetes Associates
state: Georgia
city: Roswell
country: United States
facility: Endocrine Research Solutions
state: Georgia
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Center
state: Iowa
city: Bloomfield Hills
country: United States
facility: Grunberger Diabetes Institute
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic (Rochester MN)
state: Minnesota
city: Feasterville-Trevose
country: United States
facility: Diabetes and Endocrinology Consultants of Pennsylvania
state: Pennsylvania
city: Memphis
country: United States
facility: AM Diabetes and Endocrinology Center
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
Study officials:
References:
citation: 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.