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 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT03224234
Eligibility Criteria:
Inclusion Criteria:
* Age: 18 to 80 years
* Diagnosis of T2D
* Screening HbA1c ≥ 7.5% to ≤ 11%
* Continuous treatment with one or more oral antidiabetic agents, for at least 2 months
* Continuous treatment with daily basal insulin (NPH, glargine U100 or detemir), for at least 2 months, (insulin dose ≤0.5U/Kg/day)
* If patients are on combination therapy of basal insulin and GLP1-RA, the dose of GLP-1 RA should be stable for the past three months.
* Owns a smartphone - Apple iPhone, Samsung Galaxy models
* Signed, informed consent and HIPAA documentation
* Subjects' ability to self-administer insulin, use the device and complete subject reported outcomes instruments
* Subjects' ability \& willingness to adhere to and be compliant with study protocol
Exclusion Criteria:
* Refusal or inability to give informed consent to participate in the study
* Subject is currently taking or was treated with glargine U300 insulin, degludec, insulin dose greater than 0.5 U/kg/day during the previous three months
* Subject treated with prandial insulin or premixed formulations during the previous three months
* Impaired renal function as shown by, but not limited to, eGFR \< 30 ml/min.
* Muscle weakness or hemiparesis related to previous stroke or myelopathy resulting in incoordination, muscle weakness and inability to use pen device for insulin administration
* History of diabetic ketoacidosis during the previous 6 months
* Clinical evidence of active liver disease, or serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 3 times the upper limit of the normal range
* History of hypoglycemia unawareness
* Pregnancy or lactation
* Known hypersensitivity to insulin glargine or any of the components
* Any malignancy within the last 5 years, except for adequately treated basal or squamous cell carcinoma of the skin or adequately treated cervical carcinoma in situ
* Current drug addiction or current alcohol abuse, or history of substance or alcohol abuse within the last 2 years
* Diagnosis of dementia
* Severe gastrointestinal diseases including gastroparesis
* Cardiac status NYHA III-IV
* Acute infection
* Patients on or planning to receive long term oral or injectable steroid treatment for greater than 10 days
* Patient schedule to undergo general surgery during the next 6 months
* Any disease or condition that in the opinion of the investigator and/or sponsor may interfere with the completion of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03224234
Study Brief:
Protocol Section:
NCT03224234