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

Prior treatment

• Participants with hypoglycemia unawareness or with severe hypoglycemia within the past 90 days prior to the screening visit and until Day 1
• Hospitalization (for any reason) in the past 30 days prior to the screening visit and until Day 1
• Participants using mealtime insulin for more than 10 days in the last 90 days before the screening visit and until Day 1
• Participants who used H2S app within 1 month prior to the screening visit and until Day 1 randomization
• Participants who have taken other investigational drugs within 90 days or 5 half-lives prior to screening or randomization, whichever is longer
  • The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Other illness

• Participants with diabetes other than T2DM

Lab values

• Participants 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 discretion

Other

• H2S app/ BGM is not appropriate for the participant or use of device is otherwise contraindicated (in the opinion of the investigators)

• Participants must be ≥ 20 years of age at the time of signing the informed consent
• Participants were diagnosed with T2DM prior to the screening visit
• Participants 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 1
• Participants with HbA1c between 7.5% and 11% (inclusive) at the screening visit and Day 1
• Participants with fasting self-measured blood glucose (fSMBG) or fasting plasma glucose (FPG) \>130 mg/dL at the screening visit and Day 1
• Capable of giving signed informed consent
• Willing and able to use the H2S app and glucometer