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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: Extended Infusion Set


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Wear Infusion Set<br>Each subject is given 12 Extended Wear Infusion Sets to wear. | Device: Extended Infusion Set<br>* Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.<br>* Other names: Extended Wear Infusion Set;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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