Digital Diabetes Remission Trial (DIGEST)
Diabetes Mellitus, Type 2
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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).
Sites / Locations
- Lindus Health Ltd
Arms of the Study
Arm 1
Arm 2
Experimental
Other
Intervention arm
Standard of care 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.
All participants in the control arm will receive standard care provided by the National Health Service.