Digital Diabetes Remission Trial

NCT ID: NCT05647226

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-09
• Study Completion Date: 2024-07-30

Brief 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 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention arm

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.

Group Type: EXPERIMENTAL

Digital therapeutic and intensive lifestyle programme

Intervention Type: COMBINATION_PRODUCT

Initial 12-week LED and behaviour education app.

Standard of care arm

All participants in the control arm will receive standard care provided by the National Health Service.

Group Type: OTHER

Standard of care

Intervention Type: OTHER

Standard of care.

Interventions

Digital therapeutic and intensive lifestyle programme

Initial 12-week LED and behaviour education app.

Intervention Type: COMBINATION_PRODUCT

Standard of care

Standard of care.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lindus Health

INDUSTRY

Sponsor Role: collaborator

Habitual Health Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carol Le Roux, Professor

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

Lindus Health Ltd

London, London, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 29221645 (View on PubMed)

Lean 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.

Reference Type: BACKGROUND

PMID: 30852132 (View on PubMed)

Related Links

https://www.tryhabitual.com/

Habitual Health Ltd (Sponsor)

Other Identifiers

312269

Identifier Type: -

Identifier Source: org_study_id