Digital Diabetes Remission Trial (DIGEST)
Research type
Research Study
Full title
Digital diabetes remission trial (DIGEST), an open-label, prospective, parallel design, randomised study comparing Habitual Programme (diet replacement and digital therapeutic) against standard usual care in achieving remission in type 2 diabetes mellitus (T2D).
IRAS ID
312269
Contact name
Carel le Roux
Contact email
Sponsor organisation
Habitual Health Ltd.
ISRCTN Number
ISRCTN73786674
Duration of Study in the UK
1 years, 3 months, 28 days
Research summary
Diabetes increases rates of mortality and morbidity as well as quality of life and presents a major and increasing economic burden currently accounting for 10% of total healthcare expenditure in the UK and 12.5% in the USA. Type 2 Diabetes (T2D) was previously considered a permanent and progressive chronic disease, until more recent evidence demonstrated that remission of type 2 diabetes is possible. DiRECT and DIADEM-I have shown that modest weight loss of approximately 5-10% using diet and lifestyle approaches, can improve all areas of diabetes control including glycaemia, blood pressure, lipids, quality of life and fewer comorbidity complications.
The National Diabetes audit 2019-2020 shows that although 88% of people diagnosed with T2D and other diabetes were offered structured education, there was only 16% attendance. The DIGEST study will examine the effectiveness of a remotely delivered TDR and digital therapeutic intervention to achieve T2D remission, which may be more cost effective to deliver with greater accessibility for patients, and therefore subsequently lead to substantial long-term health gains and cost savings.
The Habitual Remission Programme, consists of 3 months of diet replacements, followed-up by a further 3 months of diet reintroduction, combined with a digital behaviour change/tracking/support programme and App. The main aim of this study is to assess whether diet replacement and a digital therapeutic (Habitual Remission Programme) is more likely to lead to weight loss and remission, compared to standard usual care in adults with T2D diagnosed within the last 6 years, where remission is defined as HbA1c of less than 6.5% (<48 mmol/mol) after at least 2 months off all glucose-lowering medication, measured at 6 months.
REC name
London - London Bridge Research Ethics Committee
REC reference
22/LO/0664
Date of REC Opinion
2 Nov 2022
REC opinion
Further Information Favourable Opinion