Randomised controlled trials have shown that total diet replacement (TDR) can lead to remission of type 2 diabetes. In 2019, the English National Health Service (NHS) committed to establishing a TDR-based interventional programme delivered at scale within real-world environments; development followed of the NHS Type 2 Diabetes Path to Remission (T2DR) programme, a 12-month behavioural intervention to support weight loss involving an initial 3-month period of TDR. We assessed remission of type 2 diabetes for programme participants. In this national prospective service evaluation of programme implementation, people in England aged 18–65 years and diagnosed with type 2 diabetes in the last 6 years were referred to the programme between programme launch on Sept 1, 2020, and Dec 31, 2022. Programme data were linked to the National Diabetes Audit to ascertain HbA measurements and glucose-lowering medication prescriptions. The primary outcome was remission of type 2 diabetes at 1 year, defined as two HbA measurements of less than 48 mmol/mol recorded at least 3 months apart with no glucose-lowering medications prescribed from 3 months before the first HbA measurement, and the second HbA measurement recorded 11–15 months after the programme start date. Outcomes were assessed in two ways: for all participants who started TDR on the 12-month programme before January, 2022, for whom there were no missing data; and for all participants who started TDR on the 12-month programme before January, 2022, and had completed the programme (ie, had a valid weight recorded at month 12) by Dec 31, 2022, for whom there were no missing data. Between Sept 1, 2020, and Dec 31, 2022, 7540 people were referred to the programme; of those, 1740 started TDR before January, 2022, and therefore had a full 12-month opportunity to undertake the programme by the time of data extraction at the end of December, 2022. Of those who started TDR before January, 2022, 960 (55%) completed the programme (defined as having a weight recorded at 12 months). The mean weight loss for the 1710 participants who started the programme before January, 2022 and had no missing data was 8·3% (95% CI 7·9–8·6) or 9·4 kg (8·9–9·8), and the mean weight loss for the 945 participants who completed the programme and had no missing data was 9·3% (8·8–9·8) or 10·3 kg (9·7–10·9). For the subgroup of 710 (42%) of 1710 participants who started the programme before January, 2022, and also had two HbA measurements recorded, 190 (27%) had remission, with mean weight loss of 13·4% (12·3–14·5) or 14·8 kg (13·4–16·3). Of the 945 participants who completed the programme, 450 (48%) had two HbA measurements recorded; of these, 145 (32%) had remission, with mean weight loss of 14·4% (13·2–15·5) or 15·9 kg (14·3–17·4). Findings from the NHS T2DR programme show that remission of type 2 diabetes is possible outside of research settings, through at-scale service delivery. However, the rate of remission achieved is lower and the ascertainment of data is more limited with implementation in the real world than in randomised controlled trial settings. None.

中文翻译：

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NHS 2 型糖尿病缓解计划的早期发现：对现实世界实施情况的前瞻性评估


随机对照试验表明，完全饮食替代（TDR）可以缓解 2 型糖尿病。 2019 年，英国国家医疗服务体系 (NHS) 致力于建立基于 TDR 的干预计划，并在现实环境中大规模实施； NHS 2 型糖尿病缓解之路 (T2DR) 计划是一项为期 12 个月的行为干预措施，旨在支持减肥，其中包括最初 3 个月的 TDR 期。我们评估了项目参与者 2 型糖尿病的缓解情况。在这项针对计划实施的国家前瞻性服务评估中，在2020年9月1日计划启动至2022年12月31日期间，英格兰年龄18-65岁并在过去6年中被诊断患有2型糖尿病的人被转介至该计划。数据与国家糖尿病审计相关联，以确定 HbA1c 测量值和降糖药物处方。主要结局是 1 年时 2 型糖尿病缓解，定义为间隔至少 3 个月记录的两次 HbA1 测量值小于 48 mmol/mol，并且从第一次 HbA1 测量前 3 个月和第二次测量前 3 个月起未服用降糖药物。 HbA 测量值在计划开始日期后 11-15 个月内记录。结果以两种方式评估：对于所有在 2022 年 1 月之前开始为期 12 个月的 TDR 计划的参与者，他们没有缺失数据；以及所有在 2022 年 1 月之前开始为期 12 个月计划的 TDR 并在 2022 年 12 月 31 日之前完成该计划（即在第 12 个月记录了有效体重）的参与者，其中没有缺失数据。 2020年9月1日至2022年12月31日期间，已有7540人被转介参加该计划；其中，1740 人在 2022 年 1 月之前开始 TDR，因此在 2022 年 12 月底提取数据时有整整 12 个月的机会来开展该计划。在 2022 年 1 月之前开始 TDR 的人中，有 960 人（ 55%）完成了该计划（定义为在 12 个月时记录体重）。 2022 年 1 月之前开始该计划且无缺失数据的 1710 名参与者的平均体重减轻为 8·3% (95% CI 7·9–8·6) 或 9·4 公斤 (8·9–9· 8)，完成该计划且无缺失数据的 945 名参与者的平均体重减轻为 9·3% (8·8–9·8) 或 10·3 公斤 (9·7–10·9)。在 2022 年 1 月之前开始该计划的 1710 名参与者中，有 710 名参与者 (42%) 参与了该计划，并且还记录了两次 HbA1c 测量值，其中 190 名参与者 (27%) 的病情得到缓解，平均体重减轻了 13·4% (12·3 –14·5) 或 14·8 千克 (13·4–16·3)。在完成该计划的 945 名参与者中，450 名 (48%) 记录了两次 HbA1c 测量结果；其中，145 例 (32%) 得到缓解，平均体重减轻 14·4% (13·2–15·5) 或 15·9 kg (14·3–​​17·4)。 NHS T2DR 项目的研究结果表明，通过大规模服务提供，在研究环境之外缓解 2 型糖尿病是可能的。然而，与随机对照试验相比，在现实世界中实施时实现的缓解率较低，并且数据的确定更加有限。没有任何。