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In a recent study published in Lancet Diabetes and Endocrinologyresearchers evaluated remission of non-insulin-dependent diabetes with total meal replacement (TDR) in the UK.
In response to the rising prevalence of diabetes, the UK National Health Service (NHS) launched the Type 2 Diabetes Road to Remission (T2DR) initiative. This approach, which follows a micronutrient-rich but low-energy diet, has been shown to result in significant weight loss and long-term diabetes remission. However, the effectiveness of these treatments in real-world situations is unknown.
The T2DR program aims to help people lose weight, keep it off, and reduce the need for hypoglycemic drugs. The regimen included 20 sessions, of which 8 sessions were the TDR phase, 4 sessions were food reinstatement, and 8 sessions were weight maintenance. The TDR phase lasted 12 weeks and focused on calorie intake and coaching. The food reintroduction phase lasted 4-6 weeks and focused on eating well and setting goals. The third step, Weight Maintenance, helps individuals achieve their goals by providing monthly coaching sessions focused on behavioral modification and increasing physical activity.
This study used prospective and national-level data to investigate whether the UK NHS T2DR program is effective in remitting type 2 diabetes.
Researchers looked at data from British people aged 18 to 65 who had been diagnosed with type 2 diabetes in the past six years and were referred to a T2DR program by their GP between September 2020 and December 2022. was analyzed. Each participant had a BMI of at least 27 kg. It is adjusted to 25 kg per square meter for white people and 25 kg per square meter for other ethnicities.
Researchers used program data in conjunction with National Diabetes Audit (NDA) records to confirm glycated hemoglobin (HbA1c) levels and oral hypoglycemic medication prescriptions. Subjects' most recent HbA1c records in the previous year ranged from 43 to 87 mmol/mol for those taking hypoglycemic drugs and from 48 to 87 mmol/mol for others.
The main study findings were two HbA1c records of less than 48 mmol per mol taken at least 3 months apart without administration of hypoglycemic drugs for 3 months before the first HbA1c record; Based on measurements after 15 months, there was remission of type 2 diabetes after 1 year. Secondary outcomes include numbers and percentage changes in weight and the number of participants achieving at least 10% and 15% weight loss over 1 year.
Researchers evaluated outcomes for participants who started a TDR-based program before 2022 and completed the program by December 2022 (i.e., recorded their weight at one year) did. Multivariate regression including study covariates such as demographic variables was used for analysis. (age, gender, socio-economic status, ethnicity), clinical variables (diabetes duration, baseline BMI, HbA1c), program delivery method and provider. They evaluated different timings of subsequent HbA1c measurements (12–13 months, 12–14 months, 12–15 months, 11–13 months, and 3 weeks before to 3 weeks after 1 year). We performed a sensitivity analysis to
From September 2020 to December 2022, 7,540 people were referred to the T2DR program, with an average age of 50 years. 3,240 (43%) were male, 4,820 (64%) were white, and 1,740 started on a complete alternative diet by 2022, given a one-year opportunity to complete the program. Among individuals who started TDR before 2022, 55% (n=960) completed the program. Of the 7,540 people referred, 34% were not taking any hypoglycemic drugs, 50% were taking one and 16% were taking two or more, the most common being metformin.
By 2022, the average weight loss for the 1,710 participants who started the program was 9.40 kg (8.3%), and the average weight loss for the 945 participants who completed the program was 10 kg (9.3%). Among participants who started the program before 2022 and had two or more HbA1c records, 27% (n=190) showed diabetes remission, with an average weight loss of 15 kg or 13%. Of the 945 participants who completed the program, 48% (n=450) provided two HbA1c records. Of these, 32% (n=145) had diabetes remission, with an average weight loss of 16 kg or 14%.
Of the 945 people who completed the program, 395 (42%) lost at least 10% of their baseline weight and 190 (20%) lost at least 15% of their starting weight. Among participants in remission, 110 (76%) participants lost at least 10% of their baseline weight and 65 (45%) lost at least 15% of their initial weight. Sensitivity analyzes yielded similar results.
Based on the study results, 27% of NHS T2DR program participants achieved remission, demonstrating that remission is achievable with large-scale implementation beyond research settings. However, in real-world applications, remission rates are lower and data collection is more limited than in randomized controlled trial scenarios. These findings will contribute to more informed policy decisions about the operational effectiveness of TDR approaches and their impact on population health.