A remotely delivered behavioural support programme can help people with type 2 diabetes follow a low-carbohydrate, low-energy diet

Not Applicable

• Conditions: Type 2 diabetes; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11702341
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-19
• Last Update Posted: 18 June 2024
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Participant is willing and able to give informed consent for participation in the study
2. Male or Female, aged 18 – 65 years old
3. BMI equal to or over 27kg/m² (where individuals are from White ethnic groups) or equal to or over 25kg/m2 (where individuals are from Black, Asian and other ethnic groups)
4. Diagnosed with type 2 diabetes
5. Must have good IT skills (they can use a computer/smartphone)
6. Must complete baseline assessments

Exclusion Criteria

1. Currently diagnosed with type 2 diabetes but who are in remission using the NHS diabetes remission criteria, or who are recorded as not on diabetes medication and whose HbA1c levels on enrolment are <48mmol/mol at baseline
2. Currently using insulin injections
3. GLP1-agonists or SGLT2 inhibitors started in the six months before study enrolment
4. Diagnosed with a known eating disorder for whom the programme could be unsafe or require extensive monitoring to ensure safety
5. People who are pregnant or planning pregnancy
6. People who are breastfeeding
7. Diagnosed with a myocardial infarction or stroke in the past three months, or uncontrolled cardiac conduction abnormalities e.g. long QT syndrome.
8. Currently diagnosed with maculopathy or proliferative retinopathy
9. People with HbA1c =87mmol/mol
10. People with significant life-limiting illnesses that mean that remission is unlikely to improve health (severe cardiac failure, palliatively treated cancer, dementia), or other current severe illness
11. Planned major surgery that means that following a weight loss programme would not be possible.
12. People taking part in other research that would compromise either their participation in eDIAMOND or the other research study/ies that they are participating in.
13. Taking part in or planning to take part in the NHS Pathway to Remission programme.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in weight measured by weighing participants at the 20-week follow-up appointment and comparing this to the measurement taken at baseline