Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04823312
Status:
UNKNOWN
Last Update Posted:
2021-03-30
First Post:
2021-03-18
Brief Title:
Evaluation of Medtronic DUO Extended Set
Sponsor:
Atlanta Diabetes Associates
Organization:
Atlanta Diabetes Associates
Study Overview
Official Title:
Early Feasibility Study Evaluation of Medtronic Duo Extended Set With 670G Pump Therapy
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None