The DR-EAM Type 2 Diabetes Study
Type 2 Diabetes
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 Diabetes, Low calorie diet, Total diet replacement, behaviour change
Eligibility Criteria
Inclusion Criteria: Minimum age of 18 years Maximum age of 65 years Male or female Minimum BMI of 27kg/m2 (adjusted to 25kg/m² in people of South Asian or Chinese origin) BMI <45kg/m2 T2DM diagnosed at any time HbA1c eligibility, most recent value, which must be within 12 months: HbA1c ≥ 43 mmol/mol if on diabetes medication HbA1c ≥ 48 mmol/mol if on diet alone HBA1c <108 mmol/mol If HbA1c 90-108 mmol/mol, the value must be within 3 months of referral On, 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 referral Ability to speak, read and receive care in English Access to and willing to use an iOS or Android smart phone for the duration of the intervention Exclusion Criteria: T2DM either diet-controlled alone, or on metformin alone Current insulin use Pregnant or breastfeeding or considering pregnancy during next 6 months Significant physical comorbidities: Active cancer Myocardial infarction or stroke within previous 6 months Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) Recent eGFR <30 mls/min/1.73 m2 Active live disease (except for NAFLD), or a history of hepatoma, or <6 months of onset of acute hepatitis Severe angina, cardiac arrythmia including atrial fibrillation or prolonged QT syndrome Active substance use disorder / eating disorder Porphyria Weight 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 disabilities Taking monoamine-oxidase inhibitor medication Taking warfarin Taking varenicline (smoking cessation medication) Retinopathy diagnosis or lack of retinal screening in the last year Active/investigation for gastric or duodenal ulcers People currently participating in another clinical trial
Sites / Locations
- Oviva UK ltd
Arms of the Study
Arm 1
Experimental
Single-arm
Single-arm real-world evaluation with a matched control group from comparable GP practices