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

Study Overview
=================
Brief 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).

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

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Combination Product: Connected Solution with H2S app which connects with blood glucose meter (BGM)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device Intervention arm<br>Connected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants | Combination Product: Connected Solution with H2S app which connects with blood glucose meter (BGM)<br>* Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals<br>|
| No Intervention: No Device Control arm<br>Physician-recommended routine management (usual care) to support glycemic control in T2DM participants | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at Week 24 |  | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24 |  | Baseline to Week 24 | 
| Time to first reach the fSMBG target range | The time to first fSMBG reaching target range of 80 to 130 mg/dL (inclusive) will be defined as the time interval from Day 1 to the first date of reaching the target fSMBG | Baseline to Week 24 | 
| Insulin compliance at Week 12 and 24 | Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100% | Baseline to Week 12 and 24 | 
| Insulin discontinuation rate at Week 12 and 24 | Percentage of participants who are discontinued from the insulin injection at Week 12 and 24 | Week 12 and 24 | 
| Change from baseline in total daily insulin dose at Week 12 and 24 |  | Baseline to Week 12 and 24 | 
| Change from baseline in body weight at Week 12 and 24 |  | Baseline to Week 12 and 24 | 
| Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24 |  | Baseline to Week 12 and 24 | 
| Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24 |  | Week 24 | 
| Change from baseline in the score of the European Quality of Life 5-Dimensions 3-Level Version (EQ-5D-3L) at Week 12 and 24 |  | Baseline to Week 12 and 24 | 
| Number of participants experiencing hypoglycemia | The number of participants experiencing hypoglycemia during the 24-week study period will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available | Baseline to Week 24 | 
| Number of hypoglycemic events per patient-year during the 24-week study period | The hypoglycemic events will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available | Baseline to Week 24 | 
| Emergency room (ER) visits or hospitalizations due to hypoglycemia event | Percentage of participants with at least one ER visit or hospitalization record due to hypoglycemia event per the judgment of investigators | Baseline to Week 24 | 
| Insulin compliance at Week 12 and 24 | Compliance (%) = (the total days of participants with insulin injecting as prescribed regimen / the total days of prescribed regimen)*100% | Week 12 and 24 | 
| Number of participants experiencing hypoglycemia during the 24-week study period | The number of participants will be listed by threshold (glucose blood level ≤70 and <54 mg/dL) and by time window (nocturnal [00:00 to 05:59] and any time), where available | Baseline to Week 24 | 
| Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period |  | Baseline to Week 24 | 
| Number of participants with adverse events during the 24-week study period |  | Baseline to Week 24 |