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

 To evaluate the effect of virtual approach via novel technologies versus traditional study
 conduct on glycemic control in terms of glycated hemoglobin (HbA1c).

 Secondary Objective:

 To evaluate the appropriate utilization of virtual approach via novel technologies during the
 study and to assess the effect of the virtual versus traditional study conduct on multiple
 outcomes in terms of study methodology and diabetes management.
The study had a maximum study duration of 29 weeks, which consisted of a 3-week screening
 period (including a possible 1-week delay in first investigational medicinal product [IMP]
 administration after randomization in virtual group due to shipment of IMP and the virtual
 devices), a 24-week treatment period, and 1-week post-treatment safety follow-up period.
Inclusion criteria :

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

 -  Participants who were 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.

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

 -  eSign the consent on the study web portal.

 Exclusion criteria:

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

 -  Type 2 diabetes mellitus.

 -  HbA1c <5.4 percent (%) or greater than or equal to (>=) 9.0% measured by the central
 lab at Visit 1.

 -  Participants who received <6 months treatment with any basal plus (+) meal-time
 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.

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

 -  Participants 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 participant's ability to meet the study requirements, or participants 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 was not intended to contain all considerations relevant to a
 participant's potential participation in a clinical trial.