Evaluation of Medtronic DUO Extended Set
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|ClinicalTrials.gov Identifier: NCT04823312|
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Experimental prospective single arm evaluating the Medtronic Duo Extended Set||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Feasibility Study: Evaluation of Medtronic Duo Extended Set With 670G Pump Therapy|
|Actual Study Start Date :||March 18, 2021|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||November 1, 2021|
Experimental: Medtronic Duo Extended Set
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.
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.
Other Name: Medtronic DUO Extended Set with 670G Pump Therapy
- Number of subjects with Duo Extended set failures due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. [ Time Frame: 7 days ]Unexplained hyperglycemia
- Number of subjects with a rate of infusion set survival of 7 days or greater, excluding those that kinked on insertion or accidentally pulled out. [ Time Frame: 7 days ]Infusion set survival
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823312
|Contact: Melody L Cantrell, PharmD||404-355-4393 ext email@example.com|
|Contact: Betsy Childs, RNfirstname.lastname@example.org|
|United States, Georgia|
|Atlanta Diabetes Associates||Recruiting|
|Atlanta, Georgia, United States, 30318|
|Contact: Melody L Cantrell, PharmD 404-355-4393 ext 850 email@example.com|
|Contact: Betsy Childs, RN 404-355-4393 firstname.lastname@example.org|
|Principal Investigator: Bruce W Bode, MD|
|Principal Investigator:||Bruce W Bode, MD||Atlanta Diabetes Associates|