Digital Diabetes Remission Trial (DIGEST)

Habitual Health

Status: Invitation-only

Conditions: Diabetes Mellitus, Type 2

Treatments: Combination Product: Digital therapeutic and intensive lifestyle programme; Other: Standard of care

Study type: Interventional

Funder types: Industry

Identifiers

NCT05647226

312269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Combination Product: Digital therapeutic and intensive lifestyle programme

Standard of care arm

Other group

Description:

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

Treatment:

Other: Standard of care