Digital Diabetes Remission Trial (DIGEST)

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Combination product: Digital therapeutic and intensive lifestyle programme; Other: 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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • London, London, United Kingdom, SE1 3ER
      • Lindus Health Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Combination product: Digital therapeutic and intensive lifestyle programme; Initial 12-week LED and behaviour education app.
Other: Standard of care arm; All participants in the control arm will receive standard care provided by the National Health Service.	Other: Standard of care; Standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycaemic Control	Changes in HbA1C from baseline to mid and endpoints.	3-months- 6-months
Weight control	Changes in weight from baseline to mid and endpoints.	3-months- 6-months
Systolic blood pressure (SBP)	Changes in SBP from baseline to mid and endpoints.	3-months- 6-months
Diastolic blood pressure (DBP)	Changes in DBP from baseline to mid and endpoints.	3-months- 6-months
Medication use	Medication use reported by the participant.	Baseline, 3-months and 6-months
Weight loss ≥10kg	Number of participants that achieved ≥10kg	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	Baseline- 6-months
HbA1C <6.5% (48mmol/mol)	Number of participants with an HbA1C <6.5% (48mmol/mol) after a 6-month follow up	12-months (6-months after completing the trial).

Collaborators and Investigators

• Sponsor: Habitual Health Ltd
• Collaborators: Lindus Health
• Investigators: Principal Investigator: Carol Le Roux, Professor, Principal Investigator

Publications and helpful links

General 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.
• 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.

Helpful Links

• Habitual Health Ltd (Sponsor)

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2022
• Primary Completion (Actual): July 30, 2024
• Study Completion (Actual): July 30, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: December 9, 2022
• First Posted (Actual): December 12, 2022

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 312269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No