Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2021-03-18
2021-11-01
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject is on the MiniMed 670G insulin pump therapy within1 year prior to screening.
3. Subject is currently using Auto Mode at least 75% of the time and willing to utilize Auto Mode and Duo device during the study.
4. Subject is willing and able to perform study procedures as per investigator discretion.
5. Subject is willing to take one of the following two insulins: Humalog or Novolog
Exclusion Criteria
2. Subject is female and has a positive pregnancy screening test.
3. 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.
4. Subject is female and plans to become pregnant during the study.
5. Subject has Glycosylated hemoglobin (HbA1c) \> 8.5 % at time of screening.
6. Subject has had a history of 1 or more episodes of severe hypoglycemia.
7. 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.
8. Subject is unable to tolerate tape adhesive in the area of Duo™ Extended set or sensor.
9. 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).
10. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
11. Subject is currently abusing illicit drugs.
12. Subject is currently abusing alcohol.
13. Subject has history of adrenal disorder.
14. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening.
15. Subject has any condition that the Investigator believes would interfere with study participation.
16. 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.
17. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
18. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
19. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening.
20. 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.
21. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
22. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit.
23. Subject plans to have medical imagining (e.g., MRI, diathermy services, CT scans, etc.) over the course of the study.
18 Years
80 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Atlanta Diabetes Associates
OTHER
Responsible Party
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Principal Investigators
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Bruce W Bode, MD
Role: PRINCIPAL_INVESTIGATOR
Atlanta Diabetes Associates
Locations
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Atlanta Diabetes Associates
Atlanta, Georgia, United States
Countries
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Central Contacts
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Facility Contacts
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Melody L Cantrell, PharmD
Role: primary
Betsy Childs, RN
Role: backup
Other Identifiers
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ADA-001
Identifier Type: -
Identifier Source: org_study_id