Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy

量化糖尿病神经病变中人工胰腺相关的变化

• 批准号: MR/W030071/1
• 负责人: Shazli Azmi
• 金额: $ 26.53万
• 依托单位: University of Manchester
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2023
• 资助国家: 英国
• 起止时间: 2023 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=MR%2FW030071%2F1
• 关键词: Quantifying; Artificial; Pancreas; related; Changes

A complication of diabetes mellitus is damage to nerves called neuropathy which can lead to foot ulcers, infections and amputations. Patients with neuropathy may also experience pain, which can be difficult to control and the medications are limited by side effects. Neuropathy also affect the nerve supplying the heart and lungs (cardiac autonomic neuropathy (CAN)) which can be associated with premature death. Despite this there are no approved treatments to reverse the progression of neuropathy and management is focused on controlling blood glucose and other metabolic factors to prevent neuropathy and its symptoms from getting worse.Patients with type 1 diabetes are prescribed multiple daily injections (MDI) of insulin to manage their glucose control. However, insulin pump therapy and, more recently, automated insulin delivery (AID) or the Artificial Pancreas can be used as the insulin delivery method for patients with type 1 diabetes mellitus. Manchester Diabetes, Endocrinology and Metabolism Centre is the first adult diabetes centre in Europe to pioneer and use a commercially-approved artificial pancreas in clinical practice. Insulin pump therapy and the automatic pancreas have the advantage of being able to provide insulin at variabledoses, which is closer to the natural process occurring within an individual without diabetes. Both are currently considered to be the most physiological method of insulin delivery and have been shown to improve glycaemic control, quality of life (QOL) and reduce the risk of hypoglycaemia (low blood glucose level). We have previously shown in a small group of people that use of an insulin pump therapy may improve symptoms of painful neuropathy via a more stable glucose profile. The peaks and drops in insulin may make neuropathy worse.In the observational study we aim to investigate the use of the artificial pancreas and insulin pump therapy in their effect on neuropathy. We will use a variety of assessments and symptom questionnaires to assess structural and functional neuropathy status. We hypothesise that those patients receiving the newer technologies will demonstrate an improvement in symptoms and nerve regeneration. I will analyse data from a randomised control trial comparing the artificial pancreas to a sensor-augmented closed loop system. The purpose of this is to evaluate the impact of these on cardiac autonomic neuropathy where I believe that the artificial pancreas will be able to offer a better delivery of glucose and thus have a positive impact on CAN.This finding would have a significant impact for patients by providing evidence that patients with neuropathy would benefit from these devices. As these are devices that are already available on the NHS to patients satisfying specific criteria this study aims to show benefit in a wider cohort of patients which can be implemented immediately in clinical practice.

糖尿病的并发症是神经损伤，称为神经病变，可导致足部溃疡、感染和截肢。神经病变患者也可能会感到疼痛，这种疼痛很难控制，而且药物也受到副作用的限制。神经病变还会影响供应心脏和肺部的神经（心脏自主神经病变（CAN）），这可能与过早死亡有关。尽管如此，目前还没有批准的治疗方法可以逆转神经病变的进展，治疗的重点是控制血糖和其他代谢因素，以防止神经病变及其症状恶化。1 型糖尿病患者需要每日多次注射 (MDI) 胰岛素来管理他们的血糖控制。然而，胰岛素泵疗法以及最近的自动胰岛素输送 (AID) 或人工胰腺可用作 1 型糖尿病患者的胰岛素输送方法。曼彻斯特糖尿病、内分泌和代谢中心是欧洲第一个在临床实践中率先并使用商业批准的人工胰腺的成人糖尿病中心。胰岛素泵疗法和自动胰腺的优点是能够提供可变剂量的胰岛素，这更接近非糖尿病个体体内发生的自然过程。两者目前都被认为是最符合生理学的胰岛素输送方法，并已被证明可以改善血糖控制、生活质量 (QOL) 并降低低血糖（低血糖水平）的风险。我们之前在一小群人中证明，使用胰岛素泵疗法可以通过更稳定的血糖状况来改善疼痛性神经病的症状。胰岛素的峰值和下降可能会使神经病变恶化。在观察性研究中，我们的目的是研究人工胰腺和胰岛素泵疗法的使用对神经病变的影响。我们将使用各种评估和症状问卷来评估结构和功能性神经病状态。我们假设那些接受新技术的患者将表现出症状和神经再生的改善。我将分析一项随机对照试验的数据，该试验将人工胰腺与传感器增强闭环系统进行比较。这样做的目的是评估这些对心脏自主神经病变的影响，我相信人工胰腺将能够更好地输送葡萄糖，从而对 CAN 产生积极影响。这一发现将对患者产生重大影响通过提供证据证明神经病患者将从这些设备中受益。由于 NHS 已经向满足特定标准的患者提供了这些设备，因此本研究旨在向更广泛的患者群体展示其益处，并可立即在临床实践中实施。