Metabolic and vascular outcomes after transition to the MiniMed 780G system in adults ≥65 years with type 1 diabetes: a randomised, single-centre study.

The aim of this randomised study was to evaluate the effectiveness and safety of the MiniMed 780G system in individuals with type 1 diabetes aged ≥65 years, with HbA1c<86 mmol/mol (10%), who were naive to this technology, with the primary endpoint based on glycaemic management (time in range).

这项随机研究的目的是评估MiniMed 780G系统在65岁及以上、HbA1c<86 mmol/mol (10%)且未接触过该技术的1型糖尿病患者中的有效性和安全性，主要终点基于血糖管理（范围内的时长）。

Vascular status and other glycaemic metrics were assessed as secondary outcomes.

血管状况和其他血糖指标被评估为次要结果。

Methods

This single-centre, open labelled (outcome assessors were not masked), randomised, controlled, parallel-group trial enrolled 34 participants who were randomly assigned in a 1:1 ratio using a computer-generated randomisation schedule to either advanced hybrid closed-loop (AHCL) therapy or control therapy (multiple daily injections or continuous subcutaneous insulin infusion) and followed for 12 months.

这项单中心、开放标签（结果评估者未被蒙蔽）、随机对照、平行组试验招募了34名参与者，这些参与者使用计算机生成的随机化计划以1:1的比例随机分配到高级混合闭环（AHCL）治疗组或对照治疗组（多次日注射或持续皮下胰岛素输注），并随访了12个月。

Results

Twenty-nine participants completed the study.

29名参与者完成了该研究。

Baseline characteristics, including glycaemic metrics, were comparable across groups (p>0.05).

基线特征，包括血糖指标，在各组之间是可比的（p>0.05）。

The AHCL group demonstrated a rapid and sustained improvement in glycaemic management, with time in range increasing from 57.4% at baseline to 79.7% at 12 months (p<0.001), accompanied by reductions in hyperglycaemia as reflected by time above range and time above range 2 (nominal p<0.001; p<0.001), and with no increase in hypoglycaemia across time below range and time below range 2 (nominal p=0.463; p=1).

AHCL组显示出快速且持续的血糖管理改善，基线时血糖控制在目标范围内的时间为57.4%，而在12个月时增加至79.7%（p<0.001），同时伴随着高血糖时间的减少，如超出目标范围的时间和超出目标范围2的时间减少（名义p<0.001; p<0.001），并且在低于目标范围的时间和低于目标范围2的时间内，低血糖的发生率没有增加（名义p=0.463; p=1）。

Adjusted between-group differences favoured AHCL for time in range (15.7% [95% CI 8.6, 22.6]) and HbA1c (-5 mmol/mol; [95% CI -9.7, -0.4 mmol/mol] [-0.46%; -0.89%, -0.04%]).

调整后的组间差异显示，AHCL组在血糖控制在目标范围内的时间（15.7% [95% 置信区间 8.6, 22.6]）和HbA1c水平（-5 mmol/mol; [95% 置信区间 -9.7, -0.4 mmol/mol] [-0.46%; -0.89%, -0.04%]）方面均优于对照组。

No serious adverse events or episodes of diabetic ketoacidosis or severe hypoglycaemia occurred.

未发生严重不良事件或糖尿病酮症酸中毒或严重低血糖发作。

Post-occlusive reactive hyperaemia showed a shortening of time to maximal flow in the AHCL group, indicating a favourable numerical trend towards improved microvascular function (nominal p>0.05).

在AHCL组中，阻断后反应性充血显示出达到最大血流时间的缩短，表明微血管功能改善的有利数值趋势（名义p>0.05）。

Retinal vascular status assessed using artificial intelligence remained stable throughout follow-up in both eyes (nominal p=0.710 and p=0.563, respectively).

使用人工智能评估的视网膜血管状况在整个随访期间在两眼中保持稳定（名义上的 p=0.710 和 p=0.563，分别）。

conclusions/interpretation

The MiniMed 780G system appears effective for glycaemic management and safe for use in older adults with long-standing type 1 diabetes and a high burden of comorbidities.

MiniMed 780G系统对于血糖管理似乎有效，并且对于有长期1型糖尿病和高共病负担的老年成人使用是安全的。

A non-statistically significant numerical tendency (p>0.05) in the improvement of vascular function that requires further confirmation was also observed.

还观察到血管功能改善的非统计学显著的数值趋势（p>0.05），这需要进一步确认。

trial_registration

ClinicalTrials.gov NCT06207838.

ClinicalTrials.gov NCT06207838。