A Prospective Randomized, Double-Blind Comparison of LY900014 to Humalog with an Open-Label Postprandial LY900014 Treatment Group in Children and Adolescents with Type 1 Diabetes PRONTO-Peds
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
Conditions: Type 1 Diabetes
Age: Between 1 - 18 Years
Gender: Male or Female
Type of Patient and Disease Characteristics
 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.
 Are at least 1 to <18 years of age.
 Are ≥16 lbs. (7.3 kg).
Other Study Requirements for Patient or Caregiver
 Has refrigeration in the home or has access to refrigeration for storage of
 Are capable and willing (as determined by the investigator) to do the
a. inject insulin with the use of an insulin pen injection device according to
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
 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.
 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).
 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).
 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.
a. history of renal transplantation,
b. currently receiving dialysis, or
 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
 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.
 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.
 Have significant lipohypertrophy.
 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.
Contact the research team to learn more about this study.
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