Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Medtronic DUO Extended Set

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823312
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Atlanta Diabetes Associates

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Experimental prospective single arm evaluating the Medtronic Duo Extended Set Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Has type 1 diabetes for more than one year.
  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:

  1. 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.
  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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Melody L Cantrell, PharmD 404-355-4393 ext 850 mcantrell@atlantadiabetes.com
Contact: Betsy Childs, RN 404-355-4393 bchilds@atlantadiabetes.com

Locations
Layout table for location information
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Melody L Cantrell, PharmD    404-355-4393 ext 850    mcantrell@atlantadiabetes.com   
Contact: Betsy Childs, RN    404-355-4393    bchilds@atlantadiabetes.com   
Principal Investigator: Bruce W Bode, MD         
Sponsors and Collaborators
Atlanta Diabetes Associates
Medtronic
Investigators
Layout table for investigator information
Principal Investigator: Bruce W Bode, MD Atlanta Diabetes Associates
Layout table for additonal information
Responsible Party: Atlanta Diabetes Associates
ClinicalTrials.gov Identifier: NCT04823312    
Other Study ID Numbers: ADA-001
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Atlanta Diabetes Associates:
Diabetes Type 1
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases