Digital Diabetes Remission Trial

NCT05647226 | Completed

• 1 other identifier: 312269
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• Weight loss of ≥15kg

  Number of participants that achieved ≥15kg

  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.

  6-months

Secondary Outcomes (8)

• Glycaemic Control

  3-months- 6-months

• Weight control

  3-months- 6-months

• Systolic blood pressure (SBP)

  3-months- 6-months

• Diastolic blood pressure (DBP)

  3-months- 6-months

• Medication use

  Baseline, 3-months and 6-months

Study Arms (2)

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.

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.

Other: Standard of care

Interventions

Digital therapeutic and intensive lifestyle programme COMBINATION_PRODUCT

Initial 12-week LED and behaviour education app.

Intervention arm

Standard of care OTHER

Standard of care.

Standard of care arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Habitual Health Ltd: lead
• Lindus Health: collaborator

Study Sites (1)

Lindus Health Ltd

London, London, SE1 3ER, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29221645 BACKGROUND

• 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.

  PMID: 30852132 BACKGROUND

Related Links

• Habitual Health Ltd (Sponsor)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Carol Le Roux, Professor

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the lifestyle programme, participants, clinicians and data collectors will not be able to be masked, however allocation will be concealed from the statistician in charge of performing the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicentre, open-label, parallel design, randomised controlled trial.

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 12, 2022
• Study Start: January 9, 2022
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)