Can a smartphone app help tame diabetes and protect the liver?

NCT ID NCT07032311

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether a digital behavioral therapy app, added to standard diabetes care, can improve blood sugar control and lower the risk of liver fibrosis in adults with type 2 diabetes. The trial enrolls 180 adults with type 2 diabetes who are at low to moderate risk for liver disease. Participants in the intervention group use the app daily for behavioral modules, blood sugar tracking, and diet and activity logging, plus weekly check-ins with a health navigator. The control group receives standard care alone. Researchers measure changes in HbA1c, liver enzyme levels, and Fib-4 scores over six months.

What this could mean

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

Active substance
a software-based digital therapeutic mobile app delivering personalized behavioral therapy, diabetes education, and health tracking
What this could lead to
If it works, this could offer a scalable, low-cost way to help people with type 2 diabetes improve blood sugar control and reduce liver disease risk from home.
What could go wrong
This is an early study with 180 participants over six months, so any benefits may be modest or fade without ongoing use. Digital programs often struggle with user engagement, and results may not apply to people with more severe diabetes or liver disease.

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

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

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

18 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 * Age Threshold: Age ≥ 18 years at the time of informed consent. * Clinical Diagnosis: Confirmed diagnosis of Type 2 Diabetes Mellitus (ICD-10: E11.-) supported by: For Type 2 Diabetes: Baseline screening HbA1c above 7.0% (excluding insulin-dependent patients unlikely to benefit from adjunct behavioral intervention). * Medication Stability: Stable pharmacological regimen with no new diabetes medications or dose changes within 90 days of screening. GLP-1 receptor agonists or SGLT-2 inhibitors are permitted only if stable ≥ 90 days prior to screening (status will be captured as a stratification variable). * Clinical Oversight: Currently under the care of a licensed physician or Certified Diabetes Care and Education Specialist (CDCES). * Language \& Literacy: English language proficiency with at least a middle-school reading level, sufficient to independently engage with the SIPPA Health application content. * Device Ownership \& Connectivity: Owns a compatible Android smartphone (or willingness to accept an Android smartphone on a loan basis during the study period) with an active data plan and/or the ability to reliably send and receive text messages. Note: the current validated platform is Android; iOS subjects are not eligible in this study version. * Digital Literacy: Possess the basic technical skills required to operate an Android smartphone and navigate Android mobile applications to receive behavioral intervention/therapy in addition to standard care. * Behavioral Commitment: Expressed willingness to modify behavior, physical activity, and diet, alongside a commitment to communicate with the project team via phone, email, or SMS at least once a week. * Informed Consent: Capable of providing written informed consent. Exclusion Criteria * Current insulin therapy, excluding stable basal insulin (stable ≥ 90 days prior to screening), (ICD Z79.4) * GLP-1 receptor agonist or SGLT-2 inhibitor initiated or dosage change within 90 days of screening (ICD Z79.899) * Type 1 Diabetes Mellitus (ICD E10.9) * Severe renal impairment (eGFR \< 30 mL/min/1.73m²) (ICD N18.4) * Active malignancy or life expectancy \< 12 months (ICD C00 to C96, C51.5) * Active major depressive episode, psychosis, or inpatient psychiatric care within 12 months (ICD F32.A, F32.9, F29, Z65.8) * Pregnancy or active breastfeeding (Z33.1, Z39.1) * Concurrent enrollment in another interventional digital health or behavioral modification study (ICD Z00.6) * Prior use of BT-001 (Better Therapeutics) or SIPPA Health within 6 months of screening * Receiving Hepatotoxic Medication (ICD-10 code: K76.1) * Cirrhosis, Hepatitis B/C, and Other Chronic Liver Diseases (ICD-10 code: K.74, B19.10, B19.20, K72.1)

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Liver disease are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYC Health + Hospitals/Queens Hospital Center Diabetes Center of Excellence

    Jamaica, New York, 11432, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.