The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference −2.57 mmol/mol; 95% CI −4.5, −0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (−0.55 mmol/mol; 95% CI −2.46, 1.35; p = 0.57), or INT vs CON arms (−2.14 mmol/mol; 95% CI −4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON −4.76 mmol/mol; 95% CI −7.75, −1.78 mmol/mol) than in older participants (−0.46 mmol/mol; 95% CI −2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (−6.01 mmol/mol; 95% CI −9.56, −2.46 age < 65 years old and −0.22 mmol/mol; 95% CI −2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (−7.0 mmol/mol; 95% CI −11.5, −2.5; p = 0.003). The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. ISRCTN34805606 . Retrospectively registered 14.4.16

中文翻译：

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诺福克糖尿病预防生活方式干预 (NDPS) 对筛查检测的 2 型糖尿病患者血糖控制的影响：一项随机对照试验

该试验的目的是测试诺福克糖尿病预防研究 (NDPS) 的生活方式干预是否可以改善新诊断的筛查检测出的 2 型糖尿病患者的血糖控制，最近显示该干预措施可以降低高危人群 2 型糖尿病的发病率糖尿病。我们使用空腹血糖和糖化血红蛋白 (HbA1c) 筛查了 12,778 名 2 型糖尿病高风险参与者。筛查检测出的 2 型糖尿病患者被随机分配到一项平行、三臂、对照试验中，随访时间长达 46 个月，对照组 (CON) 是一项基于小组的生活方式干预，包括 6 个核心项目和最多15 次维持课程 (INT)，或相同的干预措施，并接受受过培训以共同实施生活方式干预的 2 型糖尿病志愿者的额外支持 (INT-DPM)。预先指定的主要终点是 12 个月时各组之间的平均 HbA1c 比较。我们对 432 名参与者（CON 149；INT 142；INT-DPM 141）进行随机分组，平均 (SD) 年龄为 63.5 (10.0) 岁，体重指数 (BMI) 为 32.4 (6.4) kg/m2，HbA1c 为 52.5（ 10.2) 毫摩尔/摩尔。与 INT-DPM 组相比，12 个月时平均 HbA1c 的主要结局（CON 48.5 (9.1) mmol/mol、INT 46.5 (8.1) mmol/mol 和 INT-DPM 45.6 (6.0) mmol/mol）显着较低与 CON 的差异（调整后的差异 -2.57 mmol/mol；95% CI -4.5, -0.6；p = 0.007），但 INT-DPM 和 INT 组之间没有显着差异（-0.55 mmol/mol；95% CI -2.46, 1.35） ；p = 0.57），或 INT 与 CON 臂（−2.14 mmol/mol；95% CI -4.33, 0.05；p = 0.07）。亚组分析显示，干预措施对年龄 < 65 岁的参与者（平均 HbA1c 与 CON 的差异 -4.76 mmol/mol；95% CI -7.75，-1.78 mmol/mol）的影响大于老年参与者（-0.46 mmol/mol） ；95% CI -2.67, 1.75；交互作用 p = 0.02）。这种效应在 INT-DPM 组中最为显着（-6.01 mmol/mol；95% CI -9.56, -2.46 年龄 < 65 岁和 -0.22 mmol/mol；95% CI -2.7, 2.25；年龄 > 65 岁）旧；p = 0.007）。与 CON 相比，口服降糖药物的使用与平均 HbA1c 显着降低相关，但仅限于 INT-DPM 组（-7.0 mmol/mol；95% CI -11.5，-2.5；p = 0.003）。在经过培训的 2 型糖尿病同伴导师的支持下，NDPS 生活方式干预在 12 个月后显着改善了筛查检测出的 2 型糖尿病患者的血糖控制，特别是那些接受口服降糖药的患者和 65 岁以下的患者。然而，效果并不显着，并且无法持续 24 个月。ISRCTN34805606。追溯注册 14.4.16