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)

July 20, 2026 updated by: Sanofi

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Trial Transparency email recommended (Toll free number for US and Canada)
  • Phone Number: option 6 800-633-1610
  • Email: contact-us@sanofi.com

Study Locations

  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital - Investigational Site Number: 1580016
      • Kaohsiung City, Taiwan, 813414
        • Kaohsiung Veterans General Hospital - Investigational site number 1580010
      • New Taipei City, Taiwan, 220
        • Far-Eastern Memorial Hospital - Investigational Site Number: 1580004
      • New Taipei City, Taiwan, 235
        • Shuang Ho Hospital - Investigational Site Number: 1580012
      • New Taipei City, Taiwan, 33305
        • Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005
      • Taichung, Taiwan, 40201
        • Chung-Shan University Hospital - Investigational Site Number: 1580003
      • Taichung, Taiwan, 435403
        • Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011
      • Tainan, Taiwan, 704302
        • National Cheng Kung University Hospital - Investigational Site Number: 1580008
      • Tainan, Taiwan, 710
        • Chi-Mai Medical Center - Investigational Site Number: 1580002
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital - Investigational site number 1580001
      • Taipei, Taiwan, 106
        • Cathay General Hospital - Investigational Site Number: 1580006
      • Taipei, Taiwan, 112201
        • Taipei Veterans General Hospital - Investigational Site Number: 1580015
      • Taipei, Taiwan, 114202
        • Tri-Service General Hospital - Investigational Site Number: 1580014
      • Taipei, Taiwan, 116079
        • Wan Fang Hospital - Investigational Site Number: 1580013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Device Intervention arm
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)
Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals
No Intervention: No Device Control arm
Physician-recommended routine management (usual care) to support glycemic control in T2DM participants

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline in HbA1c at Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24
Time Frame: Baseline to Week 24
Baseline to Week 24
Time to first reach the fSMBG target range
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to 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
Time Frame: 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
Time Frame: Baseline to Week 12 and 24
Baseline to Week 12 and 24
Change from baseline in body weight at Week 12 and 24
Time Frame: Baseline to 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
Time Frame: Baseline to Week 12 and 24
Baseline to Week 12 and 24
Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24
Time Frame: 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
Time Frame: Baseline to Week 12 and 24
Baseline to Week 12 and 24
Number of participants experiencing hypoglycemia
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 24
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
Time Frame: 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
Time Frame: Baseline to Week 24
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
Time Frame: Baseline to Week 24
Baseline to Week 24
Number of participants with adverse events during the 24-week study period
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Sciences & Operations, Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PIR17344
  • U1111-1266-5860 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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