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NHS 2 型糖尿病缓解计划的早期发现:真实世界实施情况的前瞻性评估。

Early findings from the NHS Type 2 Diabetes Path to Remission Programme: a prospective evaluation of real-world implementation.

机构信息

Prevention and Long Term Conditions Programme, Medical Directorate, NHS England, London, UK; Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK; Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.

Prevention and Long Term Conditions Programme, Medical Directorate, NHS England, London, UK.

出版信息

Lancet Diabetes Endocrinol. 2024 Sep;12(9):653-663. doi: 10.1016/S2213-8587(24)00194-3. Epub 2024 Aug 5.

Abstract

BACKGROUND

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.

METHODS

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.

FINDINGS

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).

INTERPRETATION

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.

FUNDING

None.

摘要

背景

随机对照试验表明,全饮食替代(TDR)可以导致 2 型糖尿病缓解。2019 年,英国国家卫生服务体系(NHS)承诺在真实环境中大规模建立基于 TDR 的干预项目;随后开发了 NHS 2 型糖尿病缓解途径(T2DR)计划,这是一项为期 12 个月的行为干预措施,旨在支持减肥,包括最初 3 个月的 TDR。我们评估了该项目参与者的 2 型糖尿病缓解情况。

方法

这是一项针对项目实施的全国前瞻性服务评估,在 2020 年 9 月 1 日项目启动至 2022 年 12 月 31 日期间,年龄在 18-65 岁之间、在过去 6 年内被诊断出患有 2 型糖尿病的英格兰人被转介至该项目。将项目数据与国家糖尿病审计联系起来,以确定 HbA 测量值和降低血糖药物的处方。主要结局是在 1 年内缓解 2 型糖尿病,定义为两次 HbA 测量值均低于 48mmol/mol,且至少相隔 3 个月,在第一次 HbA 测量前 3 个月内未开处方任何降低血糖的药物,且第二次 HbA 测量记录在项目启动日期后的 11-15 个月。结果通过两种方式进行评估:对于所有在 2022 年 1 月之前开始为期 12 个月的 TDR 方案的参与者,他们没有缺失数据;对于所有在 2022 年 1 月之前开始为期 12 个月的 TDR 方案且在 2022 年 12 月 31 日之前完成该方案(即,在 12 个月时记录了有效的体重)的参与者,他们没有缺失数据。

结果

在 2020 年 9 月 1 日至 2022 年 12 月 31 日期间,共有 7540 人被转介至该项目;其中,1740 人在 2022 年 1 月之前开始 TDR,因此在 2022 年 12 月 31 日数据提取时,他们有整整 12 个月的时间来完成该项目。在 2022 年 1 月之前开始 TDR 的参与者中,有 960 人(55%)完成了该项目(定义为在 12 个月时记录了体重)。在没有缺失数据的 1710 名参与者中,开始该项目且体重无缺失数据的 1710 名参与者的平均体重减轻了 8.3%(95%CI 7.9-8.6)或 9.4kg(8.9-9.8),在没有缺失数据且完成该项目的 945 名参与者中,平均体重减轻了 9.3%(8.8-9.8)或 10.3kg(9.7-10.9)。在开始该项目且没有缺失数据的 1710 名参与者中,有 710 名参与者(42%)在 2022 年 1 月之前开始,并且还进行了两次 HbA 测量,其中 190 名参与者(27%)达到了缓解,平均体重减轻了 13.4%(12.3-14.5)或 14.8kg(13.4-16.3)。在完成该项目的 945 名参与者中,有 450 名参与者(48%)进行了两次 HbA 测量;其中,145 名参与者(32%)达到了缓解,平均体重减轻了 14.4%(13.2-15.5)或 15.9kg(14.3-17.4)。

解释

来自 NHS T2DR 项目的结果表明,通过大规模服务提供,在研究环境之外也有可能缓解 2 型糖尿病。然而,与随机对照试验环境相比,在现实世界中的实施结果的缓解率较低,数据的确定也更为有限。

资金

无。

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