Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
1 other identifier
interventional
291
1 country
15
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Oct 2019
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedStudy Start
First participant enrolled
October 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 5, 2020
CompletedResults Posted
Study results publicly available
October 1, 2021
CompletedOctober 1, 2021
September 1, 2021
1.1 years
October 1, 2019
August 10, 2021
September 29, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
168 hours
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
168 hours
Study Arms (1)
Extended Wear Infusion Set
EXPERIMENTALEach subject is given 12 Extended Wear Infusion Sets to wear.
Interventions
Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
Eligibility Criteria
You may qualify if:
- Subject is age 18 - 80 years at the time of screening
- 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.
- Subject is willing and able to perform study procedures as per investigator discretion
- 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):
- Humalog™\* (insulin lispro injection)
- NovoLog™\* (insulin aspart)
You may not qualify if:
- 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.
- Subject is female and has a positive pregnancy screening test
- 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
- Subject is female and plans to become pregnant during the course of the study
- 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.
- 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
- Medical assistance (i.e. Paramedics, Emergency Room \[ER\] or Hospitalization)
- Coma
- Seizures
- 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.
- Subject is unable to tolerate tape adhesive in the area of infusion set
- Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
- Subject has infection in the area of infusion set placement at time of screening
- Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
- Subject is currently abusing illicit drugs
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Medical Investigations
Little Rock, Arkansas, 72205, United States
AMCR Institute
Escondido, California, 92025, United States
Stanford University
Palo Alto, California, 94304, United States
SoCal Diabetes
West Covina, California, 91790, United States
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
Metabolic Research Institute
West Palm Beach, Florida, 33401, United States
Atlanta Diabetes Associates
Atlanta, Georgia, 30318, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
Iowa Diabetes and Endocrinology Center
West Des Moines, Iowa, 50265, United States
Grunberger Diabetes Institute
Bloomfield Hills, Michigan, 48302, United States
Mayo Clinic (Rochester MN)
Rochester, Minnesota, 55905, United States
Diabetes and Endocrinology Consultants of Pennsylvania
Feasterville-Trevose, Pennsylvania, 19053, United States
AM Diabetes and Endocrinology Center
Memphis, Tennessee, 38133, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Related Publications (1)
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.
PMID: 35263188DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emma Pham, MSHS (Clinical Study Manager)
- Organization
- Medtronic Diabetes
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 3, 2019
Study Start
October 14, 2019
Primary Completion
November 5, 2020
Study Completion
November 5, 2020
Last Updated
October 1, 2021
Results First Posted
October 1, 2021
Record last verified: 2021-09