NCT05647226Completed
Digital Diabetes Remission Trial
Exploring the Use of Digital Therapeutics Alongside a Remote Intensive Lifestyle Programme on Inducing Weight Loss and Diabetes Remission in Patients With Type 2 Diabetes Versus Standard of Care (DIGEST)
Source: ClinicalTrials.gov · Last updated 17 Sept 2025
Brief summary (registry, in English)
This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 30 Nov 2022
- Start date
- 9 Jan 2022
- Primary completion date
- 30 Jul 2024
- Lead sponsor
- Habitual Health Ltd
- Diseases
- Type 2 diabetes
- NCT number
- NCT05647226
What you commit to
- Study type: Interventional
- Participants enrolled: 100
- From 9 Jan 2022 to the primary completion date, 30 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Is currently using Insulin
- Has had a myocardial infarction within the previous 6-months
- Is currently on treatment with anti-obesity drugs
- Has had bariatric surgery
- Has required hospitalisation for depression or taking antipsychotic drug
- Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication
Other illness
- Has a history of are known to be suffering with alcohol/substance abuse
- Has cancer or is knowingly under investigation for cancer
- Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV
- Has been diagnosed with an eating disorder or purging
- 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)
Other
- Weight of change \>5% in the past 3-months
- Has porphyria
- Has learning difficulties
- Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years
- Is currently breastfeeding
- Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
- Has pancreatitis
- Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lindus Health Ltd Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.