Evaluation of Virtual Versus Traditional Study Conducted in a Group Pilot Study in Adult Patients With Type 1 Diabetes Mellitus (eStudy)
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin glargine, 300 units per milliliter (U/mL); Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)
Intervention description: Self-administered subcutaneous injection using prefilled pen once daily for 24 weeks. Dose titration to achieve fasting self-monitoring of plasma glucose (SMPG) level between 80 and 130 milligram per deciliter (mg/dL).; Subcutaneous injection.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro; Insulin Aspart
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.