Type 2 diabetes mellitus Nutritional, Metabolic, Endocrine Type 2 diabetes mellitus
Conditions
Interventions
Diabetes-800 is a digital, remote behaviour change intervention, which provides personal 1 to 1 support and expert advice delivered either over the phone or via the Oviva App. . The programme is 12 mo
they will consume four meal replacement products per day and no food or calorie-containing drinks. In the food reintroduction phase, participants will move back onto food consumption, but will increa
Sponsors
University of Westminster
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Minimum age of 18 years 2. Maximum age of 65 years 3. Male or female 4. Minimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin) BMI <45kg/m² 5. T2DM diagnosed at any time 6. HbA1c eligibility, most recent value, which must be within 12 months: 6.1. HbA1c = 43 mmol/mol if on oral diabetes medication or GLP-1 6.2. HBA1c <108 mmol/mol - If HbA1c 90-108 mmol/mol, the value must be within 3 months of referral 7. On, or about to start, a second-line diabetes-related oral medication or GLP-1 (metformin is first-line) 8. Access to blood glucose monitoring equipment if on a sulphonylurea prior to referral 9. Ability to speak, read and receive care in English 10. Access to and willing to use an iOS or Android smartphone for the duration of the intervention
Exclusion criteria
Exclusion criteria: 1. T2DM either diet-controlled alone, or on metformin alone 2. Current insulin use 3. Pregnant or breastfeeding or considering pregnancy during next 6 months 4. Significant physical comorbidities: 4.1. Active cancer 4.2. Myocardial infarction or stroke within previous 6 months 4.3. Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA) 4.4. Recent eGFR 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) 8. 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 9. Taking monoamine-oxidase inhibitor medication 10. Taking warfarin 11. Taking varenicline (smoking cessation medication) 12. Unstable retinopathy or lack of retinal screening in the last year 13. Active/investigation for gastric or duodenal ulcers 14. People currently participating in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at baseline and 24 months: 1. Weight (measured by BodyTrace weight scale) 2. HbA1c (by venous sample collected at GP practice) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight (measured by BodyTrace weight scale) and HbA1c (by venous sample collected at GP practice) at baseline and 12 months 2. Blood pressure (measured at GP practice) at baseline, 12 and 24 months 3. Cholesterol (measured at GP practice) at baseline, 12 and 24 months 4. Physical activity (measured using a Fitbit) at baseline, 12 and 24 months 5. Quality of life (measured by EQ-5D) at baseline, 12 and 24 months 6. Participant experience surveys at baseline, 12 and 24 months 7. Diabetes medications (type and dose) at baseline, 12 and 24 months 8. Blood pressure medications (type and dose) at baseline, 12 and 24 months 9. We will also assess the participant experience by using the NHS Friends & Family Test by standardised survey, and ask participants why they agreed or declined to take part in the initial assessment and discussion of the programme 10. The study will also involve an economic evaluation of the Diabetes-800 programme compared to the matched control group accessing usual care. The impact of Diabetes-800 on NHS costs will be estimated, and extrapolated over a 5-year time period, relative to usual care. Biomedical variables and prescribing data for the intervention group during the 2-year study period will be analysed, and compared with equivalent data from a control dataset of non-participating patients with type 2 diabetes in South London. This control dataset will be used to represent usual care Trajectories for prescribing and for biomedical variables such as HbA1c, weight, blood pressure and cholesterol for years 3-5 will be estimated for the intervention group and for usual care based on evidence from the clinical literature | — |
Countries
England, United Kingdom
Outcome results
None listed