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A randomised controlled trial of a low-carbohydrate digitally-supported weight loss programme for type 2 diabetes

Abstract:
We evaluated the effectiveness of a low-carbohydrate digitally-supported weight loss programme for glycaemic control for people with type 2 diabetes (T2D) compared with usual primary care in a 12 month RCT. We individually randomised 115 people with T2D and BMI ≥27kg/m2 recruited from 19 general practices in England, to receive either a 12-week low-carbohydrate programme with digital support, or usual care. There was no between-group difference in HbA1c change from baseline to 3 or 12 months (primary outcome; estimated mean difference (95% CI) -0.7mmol/mol (-5.0 to 3.6), and -1.5 (-5.7 to 2.8), p=0.80). Greater mean weight loss in the intervention group at 3 months (2.6kg (0.6 to 4.6)), was not sustained by 12 months (-0.4kg (-2.3 to 1.6)). While this digitallydelivered intervention was acceptable to patients, there was no evidence of a meaningful impact of the intervention on glycaemia or other cardiovascular risk factors beyond that achieved with usual care. This trial was prospectively registered at clinicaltrials.gov, NCT04916314, in June 2021.
Publication status:
Published
Peer review status:
Peer reviewed

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Publisher copy:
10.1038/s41746-025-02116-w

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Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-9913-6041
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-9258-4060
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-1036-6626
More by this author
Institution:
University of Oxford
Division:
MSD
Department:
Primary Care Health Sciences
Role:
Author
ORCID:
0000-0002-1802-4217


Publisher:
Springer Nature
Journal:
npj Digital Medicine More from this journal
Volume:
8
Issue:
1
Article number:
739
Publication date:
2025-12-02
Acceptance date:
2025-10-26
DOI:
EISSN:
2398-6352
ISSN:
2398-6352


Language:
English
Pubs id:
2325835
Local pid:
pubs:2325835
Deposit date:
2025-11-13
ARK identifier:

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