Evaluation of Medtronic DUO Extended Set

Status unconfirmed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1

In brief

This study is a single-center, non-randomized, prospective single arm study of adult subjects with type 1 diabetes utilizing 670G insulin pump therapy with Continuous Glucose Monitoring (CGM). These subjects will be using 4 DUO Extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.

Key facts

Study ID

NCT04823312

Run by

Atlanta Diabetes Associates

People needed

20

Starts

2021-03-18

Expected to finish

2021-11-01

Last updated by the study team

2021-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Has type 1 diabetes for more than one year.
• Subject is on the MiniMed 670G insulin pump therapy within1 year prior to screening.
• Subject is currently using Auto Mode at least 75% of the time and willing to utilize Auto Mode and Duo device 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 two insulins: Humalog or Novolog

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 childbearing 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 study.
• Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening.
• Subject has had a history of 1 or more episodes of severe hypoglycemia.
• 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 Duo™ Extended set or sensor.
• Subject has any unresolved adverse skin condition, including infection, in the area of Duo™ Extended set or sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• 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 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, having an estimated glomerular filtration rate (eGFR)< 60mL/min/1.73 m2, 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.
• Subject plans to have medical imagining (e.g., MRI, diathermy services, CT scans, etc.) over the course of the study.

Where it is running

• Atlanta Diabetes Associates — Atlanta, Georgia, United States (enrolling)

Full record on ClinicalTrials.gov

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