NCT04823312

Evaluation of Medtronic DUO Extended Set

Early Feasibility Study: Evaluation of Medtronic Duo Extended Set With 670G Pump Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Atlanta Diabetes Associates · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Up to 20 adult subjects will be enrolled at the research center. Atlanta Diabetes Associates (ADA), with at least 15 subjects meeting the eligibility criteria. Eligibility criteria will be assessed at the screening visit and confirmed prior to Visit 2. At Visit 2, subjects will be provided supplies, including the DUO device, and will be trained on insertion. Each subject will wear their own MiniMed 670G insulin system including Guardian sensor (new sensor with transmitter will be provided for the study) and a DUO Extended set. The infusion set in the DUO Extended will be used for insulin infusion and the sensor in the DUO Extended will be blinded with a specific recorder connected to each sensor. Guardian Sensor (3) and the SMBG measurements will be used for making therapy decisions as approved for the 670G system. Subjects will upload their pump, Contour meter and GS3 sensor data each week, which will be reviewed by an investigator. Subjects will wear the DUO device for a total of four weeks. At Visit 6, subjects will come to the site to have devices uploaded, to return the investigational devices, to have a skin assessment and for labs to be drawn.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Experimental prospective single arm evaluating the Medtronic Duo Extended Set	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.

Timeline

• Start date: 2021-03-18
• Primary completion: 2021-10-01
• Completion: 2021-11-01
• First posted: 2021-03-30
• Last updated: 2021-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study