Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)

The study will have a maximum study duration of 29 weeks, which consists of a 3-week
screening period (including a possible 1-week delay in first IMP administration after
randomization in virtual group due to shipment of IMP and the virtual devices), a 24-week
treatment period, and a 2-day post-treatment safety follow-up period.

Inclusion criteria :

- Patients with Type 1 diabetes mellitus (T1DM) diagnosed at least one year before the
screening visit.

- Patients who are treated with multi-dose insulin using insulin glargine 100 U/mL (eg,
Lantus or Basaglar) as basal insulin and rapid acting insulin analogues as bolus
insulin.

- Patient with access to or experience with mobile technology (eg, tablet or smart
phone).

- eSign the consent on the study web portal.

Exclusion criteria:

- Age <18 years at screening (Visit 1 - Step 1).

- Type 2 diabetes mellitus.

- Hemoglobin A1c (HbA1c ) <5.4% or ≥9.0% measured by the central lab at Visit 1.

- Patients who received less than 6 months treatment with any basal plus mealtime
insulin.

- Use of any basal insulins other than insulin glargine 100 U/mL (eg, Lantus or
Basaglar) within 3 months before screening.

- Use of an insulin pump within 6 months before screening.

- Use of meal-time insulin other than rapid-acting insulin analogs (Humalog, Novolog, or
Apidra), eg, human regular insulin, within 30 days before screening.

- Hemoglobinopathy resulting in undetectable HbA1c by the central laboratory, or
hemolytic anemia requiring transfusion of blood or plasma products within 3 months
before screening.

- Patients experienced with any severe hypoglycemic episode resulting in seizure,
unconsciousness, or coma, and/or leading to hospitalization during the past 6 months
before screening.

- Patients with insufficient smart phone skills or unwilling to properly use the virtual
tools deemed by the investigator based on the observation and experiences over the
digital screening procedure-Mental disorders or any neurologic disorder that would
affect patient's ability to meet the study requirements, or patients deemed unlikely
to safely manage insulin dosage by the investigator.

- Known hypersensitivity/intolerance to insulin glargine, rapid-acting insulin analogs
or any of their excipients.

- Pregnant or breast-feeding women, or women who intend to become pregnant during the
study period.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.