Inclusion Criteria: 

Type of Patient and Disease Characteristics

[1] Male or female patients with T1D for at least 6 months and diagnosed by an endocrinologist (pediatric or adult), diabetes specialist, or a physician with expertise in treating pediatric patients with Type 1 diabetes.

Patient Characteristics

[2] Are at least 1 to <18 years of age.

[3] Are ≥16 lbs. (7.3 kg).

Other Study Requirements for Patient or Caregiver

[10] Has refrigeration in the home or has access to refrigeration for storage of

insulin.

[11] Are capable and willing (as determined by the investigator) to do the

following:

a. inject insulin with the use of an insulin pen injection device according to

written instructions

b. perform fingerstick SMBG as required by the study schedule using the

study glucose meter provided for all insulin dosing decisions, including

patients using a personal continuous glucose monitoring (CGM) or flash

glucose monitoring (FGM) device

c. record all information in study diary as required by this protocol

d. follow instructions for basal insulin adjustment and individualized

prandial insulin dosing using fixed-pattern adjustment or carbohydrate

counting, as provided by the investigator

e. comply with the use of study insulin and scheduled visits

Informed Consent

[12] The child/adolescent and/or a parent or legal guardian are able to understand and willingly participate fully in the activities of the clinical trial and sign their age and developmentally appropriate assent and consent, as required per local guidelines.

Exclusion Criteria: 

Medical Conditions

[13] Have current hypoglycemic unawareness in the investigator’s opinion or have had more than 1 episode of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia, indicated by coma or convulsion and/or use of intravenous glucose or glucagon) within 6 months prior to screening (Visit 1).

[14] Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening (Visit 1).

[15] Have any other clinically significant disorder or uncontrolled concomitant disease that, in the investigator's opinion, would preclude participation in the trial or pose a safety risk.

[16] Renal:

a. history of renal transplantation,

b. currently receiving dialysis, or

[17] Have obvious clinical signs or symptoms of liver disease in the opinion of

the investigator (for example, acute or chronic hepatitis or cirrhosis) or

elevated liver enzyme measurements as indicated below at screening:

a. total bilirubin ≥2× the upper limit of normal (ULN) (with the exception

of Gilbert’s disease) as defined by the central laboratory, or

[20] Blood transfusion or severe blood loss within 3 months prior to Visit 1 or

have known hemoglobinopathy, anemia, hemolytic anemia, sickle cell

anemia, or any other traits of hemoglobin abnormalities known to interfere

with the HbA1c measurement.

[21] Have history of inpatient psychiatric treatment; emotional, behavioral, or

other untreated conditions that, in the opinion of the investigator, would

interfere with proper participation in routine diabetes control and management in the last 6 months.

[22] Have significant lipohypertrophy.

[23] Retinopathy and maculopathy: have preproliferative and proliferative retinopathy, or maculopathy requiring treatment or not clinically stable in the last 6 months, or patients with active changes in subjective eye symptoms as determined by the investigator if an eye exam has not been performed in the last 6 months.