In a recent study published in The Lancet Diabetes & Endocrinology, researchers assessed insulin-independent diabetes remission by total dietary replacement (TDR) in England.
Study: Early findings from the NHS Type 2 Diabetes Path to Remission Programme: a prospective evaluation of real-world implementation. Image Credit: Kmpzzz/Shutterstock.com
Background
The growing diabetes incidence rates prompted the National Health Service (NHS) of England to launch the Type 2 Diabetes Path to Remission (T2DR) initiative. The approach follows a micronutrient-rich but low-energy diet and has demonstrated considerable weight loss and long-term diabetic remission. However, the efficacy of these therapies in real-world contexts is unknown.
The T2DR program seeks to help people lose weight, maintain it, and reduce their need for glucose-lowering medications. The regimen included 20 sessions: eight for the TDR phase, four for food reintroduction, and eight for weight maintenance. The TDR phase lasted 12 weeks and centered on calorie intake and coaching. The food reintroduction phase lasted 4-6 weeks and focused on eating well and creating objectives. The third step, weight maintenance, helps individuals achieve their goals by providing monthly coaching sessions focusing on behavior modification and promoting physical activity.
About the study
The present study used prospective and national-level data to investigate whether the English NHS T2DR program was effective in diabetes type 2 remission.
The researchers analyzed data from English individuals aged between 18 and 65 years who received diabetes type 2 diagnosis in the previous six years and referrals for the T2DR program by general practitioners between September 2020 and December 2022. Participants had BMI values of at least 27 kg per square meter if white and adjusted to 25 kg per square meter or higher for other ethnicities.
The researchers used program data in linkage with the National Diabetes Audit (NDA) records to ascertain glycated hemoglobin (HbA1c) values and oral hypoglycemic drug prescriptions. The most recent HbA1c record in the previous year of eligible individuals was 43 to 87 mmol/mol for those on glucose-lowering medications and 48 to 87 mmol/mol otherwise.
The primary study outcome was diabetes type 2 remission at one year, based on two HbA1c records under 48 mmol per mol taken three or more months apart without glucose-lowering drugs from three months before recording the initial HbA1c and measurement after 11 to 15 months. Secondary outcomes included the numerical and percent change in body weight and the number of participants attaining a weight loss of at least 10% and 15% in one year.
The researchers evaluated the outcomes for participants who began the TDR-based program before 2022 and completed the program (i.e., had their body weight documented at one year) by December 2022. They used multivariate regressions for analysis, including study covariates such as demographic variables (age, gender, socioeconomic status, and ethnicity), clinical variables (diabetes duration, baseline BMI, and HbA1c), and program delivery method and provider. They performed sensitivity analyses evaluating different timings for the subsequent HbA1c measurement (months 12 to 13, months 12 to 14, months 12 to 15, months 11 to 13, and three weeks before to three weeks after one year).
Results
Between September 2020 and December 2022, 7,540 individuals received T2DR program referrals, among whom the mean age was 50 years; 3240 (43%) were male, 4820 (64%) were white, and 1,740 initiated total dietary replacement before 2022 with a one-year opportunity to complete the program. Among individuals initiating TDR before 2022, 55% (n=960) completed the program. Out of 7,540 referred individuals, 34% were not taking glucose-lowering medications, 50% were taking one, and 16% were taking two or more, the most common one being metformin.
The mean reduction in weight among 1,710 participants starting the program before 2022 was 9.40 kg or 8.3%, and that for 945 participants completing the program was 10 kg or 9.3%. Among participants starting the program before 2022 and having two or more HbA1c records, 27% (n=190) had diabetes remission, with a mean reduction in weight of 15kg or 13%. Of 945 participants completing the program, 48% (n=450) provided two HbA1c records; of these, 32% (n=145) had diabetes remission, with a mean reduction of weight of 16 kg or 14%.
Of 945 individuals completing the program, 395 (42%) lost at least 10% of their baseline weight, and 190 (20%) lost at least 15% of their initial weight. Of those who had remission, 110 (76%) of participants lost at least 10% of their baseline weight, and 65 (45%) lost at least 15% of their initial weight. Sensitivity analyses yielded similar results.
Conclusion
Based on the study findings, 27% of NHS T2DR program participants achieved remission, showing that remission is attainable beyond research settings with at-scale delivery. However, remission rates are lower, and data collection is more constrained in real-world applications than in randomized controlled trial scenarios. These findings contribute to more informed policy judgments on the TDR approach's operational efficacy and influence on population health.
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