A Randomized Controlled Trial to Compare the Glycemic Control, With or Without the Connected Solution, of Adult Type 2 Diabetic Participants on Basal Insulin in Taiwan

The Connected Solution investigated in this study is the combination of the titration module "Insultrate" and a cell phone application (app) named Health2Sync (H2S) that synchronizes participants' self-monitoring blood glucose data and electronic health records to a platform overseen by their treating physicians. This study investigates if this Connected Solution helps to improve glycemic control more effectively than physician-recommended routine management (i.e., usual care) in participants with Type 2 Diabetes Mellitus (T2DM).

Inclusion Criteria:Participants must be ≥ 20 years of age at the time of signing the informed consentParticipants were diagnosed with T2DM prior to the screening visitParticipants who are insulin naïve, or already treated with basal insulin but uncontrolled with the same insulin regimen for at least 3 months (90 days) prior to Day 1Participants with HbA1c between 7.5% and 11% (inclusive) at the screening visit and Day 1Participants with fasting self-measured blood glucose (fSMBG) or fasting plasma glucose (FPG) >130 mg/dL at the screening visit and Day 1Capable of giving signed informed consentWilling and able to use the H2S app and glucometerExclusion Criteria:Participants with diabetes other than T2DMH2S app/ BGM is not appropriate for the participant or use of device is otherwise contraindicated (in the opinion of the investigators)Participants with hypoglycemia unawareness or with severe hypoglycemia within the past 90 days prior to the screening visit and until Day 1Hospitalization (for any reason) in the past 30 days prior to the screening visit and until Day 1Participants with severe conditions/concomitant diseases precluding their safety or ability to participate in this study, as judged by the investigators - Participants are not on stable dose of glucose lowering therapy including OADs, glucagon-like peptide-1 (GLP-1) receptor agonists, or basal insulin therapy within the past 12 weeks prior to the screening visit and until Day 1 per investigator's discretionParticipants using mealtime insulin for more than 10 days in the last 90 days before the screening visit and until Day 1Participants who used H2S app within 1 month prior to the screening visit and until Day 1 randomizationParticipants who have taken other investigational drugs within 90 days or 5 half-lives prior to screening or randomization, whichever is longerThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.