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Can a phone app and 800-Calorie diet reverse type 2 diabetes?

NCT ID NCT05647226

Disease control Sponsor: Habitual Health Ltd Source: ClinicalTrials.gov ↗

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested whether a digital app combined with a 12-week very low-calorie diet (800 calories per day) could help adults with type 2 diabetes lose weight and achieve remission. One hundred participants were randomly assigned to either the digital program or standard care. The main goals were weight loss of at least 15 kg and blood sugar levels below the diabetes threshold without medication.

What this could mean

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

Active substance
digital therapeutic app and low-energy diet (800 kcal/day)
What this could lead to
If successful, this could offer a remote, scalable way to help people with type 2 diabetes lose significant weight and achieve remission without medication.
What could go wrong
This is a small, completed trial with 100 participants, so results may not apply to everyone. The strict low-calorie diet is hard to maintain long-term, and remission may not be permanent.

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

100 people

The number who actually took part.

Started

Jan 2022

Finished

Jul 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

18 to 75 years

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: * Able and willing to give consent for the study prior to participation * Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration \<6years. * Has access to a smartphone or computer * Has a Body Mass Index (BMI) of ≥28 kg/m2 * HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months Exclusion Criteria * Is currently using Insulin * Weight of change \>5% in the past 3-months * Has a history of are known to be suffering with alcohol/substance abuse * Has cancer or is knowingly under investigation for cancer * Has had a myocardial infarction within the previous 6-months * Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV * Has porphyria * Has learning difficulties * Is currently on treatment with anti-obesity drugs * Has had bariatric surgery * Has been diagnosed with an eating disorder or purging * Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years * Is currently breastfeeding * Has required hospitalisation for depression or taking antipsychotic drug * Has a history of illnesses that could interfere with the interpretation of the study (e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years) * Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) * Has pancreatitis * Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication * Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).

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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.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Lindus Health Ltd

    London, London, SE1 3ER, United Kingdom

More trials for these conditions

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