Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-25 @ 2:00 AM
NCT ID:
NCT04113694
Eligibility Criteria:
Inclusion Criteria:
1. Subject is age 18 - 80 years at the time of screening
2. Subject has type 1 diabetes for more than one year Study specific inclusion criteria
3. Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) 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 insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount):
1. Humalog™\* (insulin lispro injection)
2. NovoLog™\* (insulin aspart)
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 child bearing 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 course of the study
5. Subject has Glycosylated hemoglobin (HbA1c) \> 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
6. Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening
1. Medical assistance (i.e. Paramedics, Emergency Room \[ER\] or Hospitalization)
2. Coma
3. Seizures
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 infusion set
9. Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
10. Subject has infection in the area of infusion set placement at time of screening
11. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
12. Subject is currently abusing illicit drugs
13. Subject is currently abusing alcohol
14. Subject is on dialysis (for renal failure)
15. Subject has history of adrenal disorder
16. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
17. Subject has any condition that the Investigator believes would interfere with study participation
18. 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
19. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
20. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
21. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
22. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
23. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
24. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04113694
Study Brief:
Protocol Section:
NCT04113694