Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eli Lilly and Company
Age
21–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Have a Type 1 Diabetes Mellitus (T1D) or a Type 2 Diabetes Mellitus (T2D) diagnosis
Must be taking a mealtime bolus dose insulin, greater than or equal to (≥) 3 doses
Each individual bolus insulin dose must be less than (\<) 40 units
Must be taking a stable insulin dose regimen for the last 3 months
Must be taking a bolus insulin analog (for example insulin lispro \[U-100\]/\[U-200\], insulin aspart, or insulin glulisine). In addition, must be able to switch to insulin lispro U-100 for the duration of the trial
Must have a hemoglobin A1c (HbA1c) ≥8.0% in the last 6 months
Participants with T1D must be ≥21 to less than or equal to (≤) 65 years of age. Participants with T2D must be ≥35 to ≤65 years of age
Women of childbearing potential must meet the following: (Note: females of childbearing potential are defined as those who have experienced menarche and who are NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause)
* Must agree to use 1 highly effective method of contraception, or a combination of 2 effective methods of contraception for the entirety of the study
* Must test negative for pregnancy as indicated by a negative serum or urine pregnancy test
Participants with prior CGM/flash glucose monitoring experience must have stopped CGM/flash glucose monitoring ≥3 months prior to enrollment
You may not be if
Have known tape/adhesive allergies with CGM sensors
Medical conditions, visual, physical, psychiatric, or cognitive impairment(s) that may preclude the ability to participate in the trial
Have history of liver disease, acute or chronic hepatitis, or alanine aminotransferase or aspartate aminotransferase levels ≥3 times the upper limit of the reference range within the last 6 months
Have history of chronic kidney disease stage 4 and higher within the last 6 months, or history of renal transplantation
Have active malignancy
Are pregnant or planning to become pregnant
Are on or are intending to begin a weight loss program
Participants with T1D who have taken off-label antihyperglycemic agents within last 3 months
Have received insulin by continuous subcutaneous insulin infusion in the last 3 months
Participants taking opioid medications for medically invalid reasons or at doses considered excessive
Participants on routine use of acetaminophen
Currently undergoing systemic treatment with:
* Immunosuppressive medication
* Chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the prior 2 weeks
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 30 days, in a clinical study involving an investigational product
Are unwilling or unable to comply with the use of a data collection device to directly record data
Clareo Health | Assessment of Mealtime Bolus Insulin Behavior
