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Type 2 Diabetes MellitusTW CES RCTNCT05684341

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

A study testing Connected Solution with H2S app which connects with blood glucose meter (BGM) in people with Type 2 Diabetes Mellitus, run by Sanofi at 14 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Connected Solution with H2S app which connects with blood glucose meter (BGM)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
14 sitesTaiwan
Study dates
17 Feb 2023to 18 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
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  • 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 locations and contacts

14 sites in 1 country.

14 sites in 1 country

Taiwan14 sites

  • Changhua Christian Hospital - Investigational Site Number: 1580016

    Changhua, 500

  • Kaohsiung Veterans General Hospital - Investigational site number 1580010

    Kaohsiung City, 813414

  • Far-Eastern Memorial Hospital - Investigational Site Number: 1580004

    New Taipei City, 220

  • Shuang Ho Hospital - Investigational Site Number: 1580012

    New Taipei City, 235

  • Chang-Gung Memorial Hospital Linkou Branch - Investigational Site Number: 1580005

    New Taipei City, 33305

  • Chung-Shan University Hospital - Investigational Site Number: 1580003

    Taichung, 40201

  • Tungs' Taichung Metroharbor Hospital - Investigational Site Number:1580011

    Taichung, 435403

  • National Cheng Kung University Hospital - Investigational Site Number: 1580008

    Tainan, 704302

  • Chi-Mai Medical Center - Investigational Site Number: 1580002

    Tainan, 710

  • National Taiwan University Hospital - Investigational site number 1580001

    Taipei, 100

  • Cathay General Hospital - Investigational Site Number: 1580006

    Taipei, 106

  • Taipei Veterans General Hospital - Investigational Site Number: 1580015

    Taipei, 112201

  • Tri-Service General Hospital - Investigational Site Number: 1580014

    Taipei, 114202

  • Wan Fang Hospital - Investigational Site Number: 1580013

    Taipei, 116079

Other trials in Taiwan

About this study

Official title: 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).

Read the 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).

Being tested
Connected Solution with H2S app which connects with blood glucose meter (BGM)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Connected Solution with H2S app which connects with blood glucose meter (BGM)Combination product

    Combination of the Insultrate titration module software, the H2S app for participants, and the H2S platform for healthcare professionals

Study groups in NCT05684341
Study groupRoleWhat they receive
Device Intervention armExperimentalConnected Solution with H2S app which connects with blood glucose meter (BGM) to support glycemic control in T2DM participants
Receives: Combination Product: Connected Solution with H2S app which connects with blood glucose meter (BGM)
No Device Control armNo interventionPhysician-recommended routine management (usual care) to support glycemic control in T2DM participants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in HbA1c at Week 24

    Measured: Baseline to Week 24

Secondary outcomes (16)

  1. Change from baseline in fasting (morning premeal) SMBG (fSMBG) at Week 24

    Measured: Baseline to Week 24

  2. 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

    Measured: Baseline to Week 24

  3. 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%

    Measured: Baseline to Week 12 and 24

  4. Insulin discontinuation rate at Week 12 and 24

    Percentage of participants who are discontinued from the insulin injection at Week 12 and 24

    Measured: Week 12 and 24

  5. Change from baseline in total daily insulin dose at Week 12 and 24

    Measured: Baseline to Week 12 and 24

  6. Change from baseline in body weight at Week 12 and 24

    Measured: Baseline to Week 12 and 24

  7. Change from baseline in the score of Diabetes Treatment Satisfaction Questionnaire status version (DTSQs) at Week 12 and 24

    Measured: Baseline to Week 12 and 24

  8. Scores of the Diabetes Treatment Satisfaction Questionnaire change version (DTSQc) at Week 24

    Measured: Week 24

  9. 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

    Measured: Baseline to Week 12 and 24

  10. 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

    Measured: Baseline to Week 24

  11. 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

    Measured: Baseline to Week 24

  12. 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

    Measured: Baseline to Week 24

  13. 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%

    Measured: Week 12 and 24

  14. 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

    Measured: Baseline to Week 24

  15. Percentage of participants with at least one emergency room (ER) visit or hospitalization record due to hypoglycemia event during the 24-week study period

    Measured: Baseline to Week 24

  16. Number of participants with adverse events during the 24-week study period

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2023
  2. Study start17 Feb 2023
  3. Primary completion18 Jun 2024
  4. Study completion18 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05684341
Sponsor's protocol ID
PIR17344
Other IDs
U1111-1266-5860
Acronym
TW CES RCT
Status last verified
Jul 2026
First submitted
5 Jan 2023
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Lu CH, Chu CH, Ou HY, Tseng YH, Wu CZ, Jiang JY, Tu ST, Yang YS, Tsai MT, Wang CY. Effectiveness and safety of connected solutions among people with type 2 diabetes uncontrolled on oral anti-diabetic drugs: A randomized real-world study on Insultrate. Prim Care Diabetes. 2026 Aug;20(4):411-417. doi: 10.1016/j.pcd.2026.04.012. Epub 2026 May 1.

    PubMed 42067440

Questions about this trial

What is this clinical trial studying?

A study testing Connected Solution with H2S app which connects with blood glucose meter (BGM) in people with Type 2 Diabetes Mellitus, run by Sanofi at 14 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in HbA1c at Week 24 (time frame: Baseline to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05684341, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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