The DR-EAM Type 2 Diabetes Study

The goal of this 12-month interventional study is to analyse the clinical outcome benefits, scalability and cost-effectiveness of a digital Low-Calorie digital Type 2 diabetes mellitus (T2DM) remission program compared to usual National Health System (NHS) care.

Inclusion Criteria:Minimum age of 18 yearsMaximum age of 65 yearsMale or femaleMinimum BMI of 27kg/m2 (adjusted to 25kg/m² in people of South Asian or Chinese origin)BMI <45kg/m2T2DM diagnosed at any timeHbA1c eligibility, most recent value, which must be within 12 months:HbA1c ≥ 43 mmol/mol if on diabetes medicationHbA1c ≥ 48 mmol/mol if on diet aloneHBA1c <108 mmol/molIf HbA1c 90-108 mmol/mol, the value must be within 3 months of referralOn, or about to start, a second-line diabetes-related medication (metformin is first-line)Access to blood glucose monitoring equipment if on a sulphonylurea prior to referralAbility to speak, read and receive care in EnglishAccess to and willing to use an iOS or Android smart phone for the duration of the interventionExclusion Criteria:T2DM either diet-controlled alone, or on metformin aloneCurrent insulin usePregnant or breastfeeding or considering pregnancy during next 6 monthsSignificant physical comorbidities:Active cancerMyocardial infarction or stroke within previous 6 monthsSevere heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)Recent eGFR <30 mls/min/1.73 m2Active live disease (except for NAFLD), or a history of hepatoma, or <6 months of onset of acute hepatitisSevere angina, cardiac arrythmia including atrial fibrillation or prolonged QT syndromeActive substance use disorder / eating disorderPorphyriaWeight loss >5% body weight within last 6 months or on current weight management programme or had/awaiting bariatric surgery (unless willing to come off waiting list)Health professional assessment that the person is unable to understand or meet the demands of the treatment programme and/or monitoring requirements, which may include -Learning disabilitiesTaking monoamine-oxidase inhibitor medicationTaking warfarinTaking varenicline (smoking cessation medication)Retinopathy diagnosis or lack of retinal screening in the last yearActive/investigation for gastric or duodenal ulcersPeople currently participating in another clinical trial