NCT05684341

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

Prospective Comparison of Connected Solution (Health2Sync) and Usual Care in Adult Participants With Type 2 Diabetes Mellitus Using Basal Insulin in Taiwan

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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).

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Connected Solution with H2S app which connects with blood glucose meter (BGM)	Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals

Timeline

• Start date: 2023-02-17
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2023-01-13
• Last updated: 2024-07-17

Locations

14 sites across 1 country: Taiwan