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Smartphone app could improve blood sugar control in type 2 diabetes

NCT ID NCT05684341

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study tests whether a connected smartphone app called Health2Sync helps adults with type 2 diabetes who use basal insulin achieve better blood sugar control. The app syncs blood glucose readings and shares them with doctors, who can then adjust insulin doses. Researchers compare this approach to standard care to see if it leads to lower HbA1c levels after 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Connected Solution with H2S app which connects with blood glucose meter (BGM)
What this could lead to
If successful, this connected app could help people with type 2 diabetes achieve better blood sugar control with fewer doctor visits.
What could go wrong
This is a relatively small study in Taiwan, and results may not apply to other populations. The app's benefit over usual care may be modest or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

200 people

The number who actually took part.

Started

Feb 2023

Finished

Jun 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes mellitus

Contacts and locations

Locations

  • Cathay General Hospital - Investigational Site Number: 1580006

    Taipei, 106, Taiwan

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

    New Taipei City, 33305, Taiwan

  • Changhua Christian Hospital - Investigational Site Number: 1580016

    Changhua, 500, Taiwan

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

    Tainan, 710, Taiwan

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

    Taichung, 40201, Taiwan

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

    New Taipei City, 220, Taiwan

  • Kaohsiung Veterans General Hospital - Investigational site number 1580010

    Kaohsiung City, 813414, Taiwan

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

    Tainan, 704302, Taiwan

  • National Taiwan University Hospital - Investigational site number 1580001

    Taipei, 100, Taiwan

  • Shuang Ho Hospital - Investigational Site Number: 1580012

    New Taipei City, 235, Taiwan

  • Taipei Veterans General Hospital - Investigational Site Number: 1580015

    Taipei, 112201, Taiwan

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

    Taipei, 114202, Taiwan

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

    Taichung, 435403, Taiwan

  • Wan Fang Hospital - Investigational Site Number: 1580013

    Taipei, 116079, Taiwan

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