The Transform Type 2 Diabetes Study

Launched by OVIVA UK LTD · Dec 5, 2022

Keywords

ClinConnect Summary

To date, there is little evidence focusing on preferences, motivating factors, and engagement in adults with type 2 diabetes when following dietary interventions to improve glycaemic control, nor on patient responses to remote group and one-to-one programs. In particular, this evidence is not available in populations with high levels of deprivation and that are culturally and ethnically diverse in which diabetes is most prevalent.

The 120 participants will be recruited from GP practices in the Southwark area. Practices will be split into two comparable groups based on the demographic and c...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Registered with one of the Nexus Group GP Practices
• • Willing to give consent for participation including collection of clinical outcomes
• • Diagnosis of type 2 diabetes
• • Minimum age of 18 years
• • Maximum age of 70 years
• • Minimum BMI of 27kg/m² (adjusted to 25kg/m² in people of South Asian or Chinese origin)
• • Upper weight limit of 180kg (due to upper weight limit of BodyTrace scales)
• * HbA1c eligibility:
• • If on diabetes medication, HbA1c ≥ 43 mmol/mol
• • If on diet alone, HbA1c ≥ 48 mmol/mol
• • HbA1c \<108mml/mol
• • Ability to speak, read and receive care in English
• • Access to internet and email address
• Exclusion Criteria:
• • Currently taking insulin
• • Pregnant or planning to be pregnant in the next 6 months
• • Current breastfeeding
• * Significant physical comorbidities:
• • Active cancer, receiving treatment
• • Myocardial infarction or stroke in last 6 months
• • Severe heart failure defined as equivalent to the New York heart Association grade 3 or 4 (NYHA)
• • eGFR \<30 mls/min/1.73m2
• • Active liver disease (except non-alcoholic fatty liver disease (NAFLD),Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndrome
• • Active substance use disorder
• • Active eating disorder
• • Porphyria
• • On current weight management programme / had or 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 programme and/or monitoring requirements
• • Taking monoamine-oxidase inhibitor medication
• • Taking warfarin
• • Taking varenicline (smoking cessation medication)
• • Have attended for monitoring and diabetes review when this was last offered, including retinal screening, and commit to continue attending reviews, even if remission is achieved
• • Active/investigation for gastric or duodenal ulcers

Trial Officials