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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

NCT05684341

CompletedNA

Sponsor: Sanofi

Conditions: Type 2 Diabetes Mellitus

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

Countries: 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).

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (14)

Changhua, Taiwan
Kaohsiung City, Taiwan
New Taipei City, Taiwan
New Taipei City, Taiwan
New Taipei City, Taiwan
Taichung, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taipei, Taiwan