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 (TW CES RCT)

Sanofi

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Combination Product: Connected Solution with H2S app which connects with blood glucose meter (BGM)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05684341

U1111-1266-5860 (Registry Identifier)

PIR17344

Details and patient eligibility

About

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).

Full description

Study duration per participant will be up to 9 months, including a screening period of up to 3 months and a study intervention period of 24 weeks (± 14 days).

Enrollment: 200 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Participants with diabetes other than T2DM
• H2S 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 1
• Hospitalization (for any reason) in the past 30 days prior to the screening visit and until Day 1
• 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
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Device Intervention arm

Experimental group

Description:

Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants

Treatment:

Combination Product: Connected Solution with H2S app which connects with blood glucose meter (BGM)

No Device Control arm

No Intervention group

Description:

Physician-recommended routine management (usual care) to support glycemic control in T2DM participants