Status:
COMPLETED
Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Lead Sponsor:
Medtronic Diabetes
Conditions:
Diabetes
Eligibility:
All Genders
18-80 years
Phase:
NA
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 sub...
Eligibility Criteria
Inclusion
- Subject is age 18 - 80 years at the time of screening
- Subject has type 1 diabetes for more than one year Study specific inclusion criteria
- 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)
Exclusion
- 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
- Subject is currently abusing alcohol
- Subject is on dialysis (for renal failure)
- Subject has history of adrenal disorder
- Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
- Subject has any condition that the Investigator believes would interfere with study participation
- 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
- Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
- Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
- Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
- 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
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 5 2020
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT04113694
Start Date
October 14 2019
End Date
November 5 2020
Last Update
October 1 2021
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical Investigations
Little Rock, Arkansas, United States, 72205
2
AMCR Institute
Escondido, California, United States, 92025
3
Stanford University
Palo Alto, California, United States, 94304
4
SoCal Diabetes
West Covina, California, United States, 91790