Diabetes Mellitus, Type 2DIGESTNCT05647226
Digital Diabetes Remission Trial
A study testing Digital therapeutic and intensive lifestyle programme in people with Diabetes Mellitus, Type 2, run by Habitual Health Ltd at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Digital therapeutic and intensive lifestyle programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Jan 2022to 30 Jul 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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.
Read the detailed description
Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.
Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Digital therapeutic and intensive lifestyle programme, Standard of care
- 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.
Digital therapeutic and intensive lifestyle programmeCombination product
Initial 12-week LED and behaviour education app.
Standard of careOther
Standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intervention participants will be given an initial 12-week low energy-diet (LED) and will have continual use of an intensive behaviour education programme delivered through an app. Receives: Combination Product: Digital therapeutic and intensive lifestyle programme |
| Standard of care arm | Other | All participants in the control arm will receive standard care provided by the National Health Service. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss of ≥15kg
Number of participants that achieved ≥15kg
Measured: 6-months
HbA1C <6.5% (48mmol/mol)
Number of participants who have achieved HbA1C <6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
Measured: 6-months
Secondary outcomes (8)
Glycaemic Control
Changes in HbA1C from baseline to mid and endpoints.
Measured: 3-months- 6-months
Weight control
Changes in weight from baseline to mid and endpoints.
Measured: 3-months- 6-months
Systolic blood pressure (SBP)
Changes in SBP from baseline to mid and endpoints.
Measured: 3-months- 6-months
Diastolic blood pressure (DBP)
Changes in DBP from baseline to mid and endpoints.
Measured: 3-months- 6-months
Medication use
Medication use reported by the participant.
Measured: Baseline, 3-months and 6-months
Weight loss ≥10kg
Number of participants that achieved ≥10kg
Measured: 6-months
Safety of Intervention
Monitoring the number of Adverse Events (AEs), Severe Adverse Events (SAEs) and (S)AE's that constitute Major Adverse Cardiovascular Events and Major Adverse Diabetes Events
Measured: Baseline- 6-months
HbA1C <6.5% (48mmol/mol)
Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up
Measured: 12-months (6-months after completing the trial).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2022
- Study start9 Jan 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- A multicentre, open-label, parallel design, randomised controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habitual Health Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Responsible party
- Sponsor
- Investigators
- Carol Le Roux, Professor, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05647226
- Sponsor's protocol ID
- 312269
- Acronym
- DIGEST
- Status last verified
- Sep 2025
- First submitted
- 30 Nov 2022
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be entered into a validated Electronic Data Capture (EDC) platform. Direct access to the EDC platform will be granted to authorised representatives from the Sponsor, Lindus Health and the regulatory authorities to allow trial-related monitoring, audits and inspections.
Publications
Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
PubMed 29221645Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
PubMed 30852132
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05647226
- Acronym / sponsor ID
- DIGEST / 312269
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Habitual Health LtdIndustry (pharma, biotech, devices)
- Collaborators
- Lindus Health
- Study start
- 9 Jan 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.
Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A multicentre, open-label, parallel design, randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Combination Product: Digital therapeutic and intensive lifestyle programmeIntervention participants will be given an initial 12-week low energy-diet (LED) and will have continual use of an intensive behaviour education programme delivered through an app. |
| Standard of care arm | Other | Other: Standard of careAll participants in the control arm will receive standard care provided by the National Health Service. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital therapeutic and intensive lifestyle programmeInitial 12-week LED and behaviour education app. | Combination product | Intervention arm |
| Standard of careStandard of care. | Other | Standard of care arm |
Primary outcome
Weight loss of ≥15kg
Time frame: 6-months
Number of participants that achieved ≥15kg
HbA1C <6.5% (48mmol/mol)
Time frame: 6-months
Number of participants who have achieved HbA1C <6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
8 secondary outcomes
Glycaemic Control
Time frame: 3-months- 6-months
Weight control
Time frame: 3-months- 6-months
Systolic blood pressure (SBP)
Time frame: 3-months- 6-months
Diastolic blood pressure (DBP)
Time frame: 3-months- 6-months
Medication use
Time frame: Baseline, 3-months and 6-months
Weight loss ≥10kg
Time frame: 6-months
Safety of Intervention
Time frame: Baseline- 6-months
HbA1C <6.5% (48mmol/mol)
Time frame: 12-months (6-months after completing the trial).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Background: PubMed 29221645Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.
- Background: PubMed 30852132Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.
- Habitual Health Ltd (Sponsor)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Data will be entered into a validated Electronic Data Capture (EDC) platform. Direct access to the EDC platform will be granted to authorised representatives from the Sponsor, Lindus Health and the regulatory authorities to allow trial-related monitoring, audits and inspections.
Related trials for Diabetes Mellitus, Type 2
Not yet recruiting
Efficacy, Safety, and Treatment Satisfaction of Once-Weekly Tirzepatide in Obese Type 2 Diabetic Patients
Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Active, not recruiting
Helping Adults With Type 2 Diabetes Use Their Health Data for Healthy Diabetes Self-Management
Type 2 Diabetes Mellitus (T2DM)
Not yet recruiting
Care COMPASS Study
Diabetes Mellitus ( Type 1 and Type 2), Hypertension
Enrolling by invitationObservational study
Personalizing A1c Using Hematologic Indices and CGM for Accurate Diabetes Diagnosis
Type 2 Diabetes
RecruitingObservational study
Investigating the Link Between Advanced Glycation End Products (AGEs) and Muscle Wasting in Sarcobesity
Sarcopenia, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Le Roux, Professor principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital therapeutic and intensive lifestyle programme in people with Diabetes Mellitus, Type 2, run by Habitual Health Ltd at 1 site in United Kingdom.
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 5 inclusion and 19 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 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Weight loss of ≥15kg (time frame: 6-months). The study lists 2 primary outcomes in all. 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 NCT05647226, which also lists 2 linked publications.
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 17 Sep 2025.