Digital behaviour change and type 2 diabetes remissio

Not Applicable

Completed

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

• Registration Number: ISRCTN71342421
• Lead Sponsor: niversity of Westminster

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-01
• Study Completion: 2023-04-30
• Last Update Posted: 22 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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

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 <30 mls/min/1.73 m²
4.5. Active live disease (except for NAFLD), or a history of hepatoma, or <6 months of onset of acute hepatitis
4.6. Severe angina, cardiac arrhythmia including atrial fibrillation or prolonged QT syndrome
5. Active substance use disorder/eating disorder
6. Porphyria
7. 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)
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Measured at baseline and 24 months:<br>1. Weight (measured by BodyTrace weight scale)<br>2. HbA1c (by venous sample collected at GP practice)