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Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and sensor-augmented pump therapy in outpatient settings

双激素人工胰腺、单激素人工胰腺和传感器增强泵疗法在门诊环境中的比较

基本信息

批准号：
8975051
负责人：
Remi Rabasa-Lhoret
金额：
$ 250.94万
依托单位：
CLINICAL RESEARCH INSTITUTE OF MONTREAL
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2021-08-31
项目状态：
已结题

项目摘要

DESCRIPTION (provided by applicant): In controlled inpatient settings, many studies have demonstrated the feasibility of the automated AP to prevent hypoglycemia and decrease mean glucose levels. The recent development of a portable automated AP has facilitated the transition from controlled research-center studies to larger outpatient studies. Most of the research groups are comparing sensor-augmented pump therapy (SAP) and the AP delivering insulin only. We have implemented a comprehensive AP research program addressing key issues of glucose control systematically using randomized controlled design. We have developed two configurations of the AP, one that infuses insulin and one that infuses insulin and glucagon. Since 2011, we have completed 6 studies, 2 are ongoing and 1 will start shortly (170 patients including 50 pediatric patients representing over 720 days of testing). These studies address glucose control during the entire day (up to 60 consecutive hours) and overnight, in specific situations such as simplified postprandial control and exercise, as well as in specific populations such as pediatrics and patients with hypoglycemia unawareness. Research projects are conducted at the clinical research center and in outpatient settings. Overall, in our studies, AP increases time spent in target range by 10% to 23% while at the same time reduces time in hypoglycemia by 4 to 8-fold. As compared to single-hormone AP, dual-hormone AP does not appear to improve time in target but is associated in most studies with a further 2 to 4-fold additional hypoglycemic risk reduction. The objective of this proposal is to compare the effectiveness of single-hormone (insulin) AP, dual-hormone (insulin and glucagon) AP and SAP with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adults and children with type 1 diabetes. An open-label, multicenter, randomized design will be used. This trial will be preceded by a pilot study of 2 weeks to verify the engineering robustness of the automated AP. This will also allow us to confirm power calculations for the 15-week study. To successfully conduct this trial, we have gathered a multidisciplinary team of pediatric and adult endocrinologists, engineers, biostatistician, and regulatory-affairs professionals. We have also secured a network of sites for multicentre trials. To the best of our knowledge, this study will be the largest (n=100) randomized trial comparing single-hormone AP, dual-hormone AP and SAP with low-glucose suspend.

描述（由申请人提供）：在受控住院环境中，许多研究已经证明了自动AP预防低血糖和降低平均血糖水平的可行性。便携式自动AP的最新发展促进了从对照研究中心研究到更大的门诊研究的过渡。大多数研究小组正在比较传感器增强泵治疗（SAP）和AP仅输送胰岛素。我们已经实施了一项全面的AP研究计划，采用随机对照设计系统地解决血糖控制的关键问题。我们已经开发了两种配置的AP，一种是输注胰岛素，另一种是输注胰岛素和胰高血糖素。自2011年以来，我们已经完成了6项研究，2项正在进行中，1项即将开始（170例患者，包括50例儿科患者，代表超过720天的测试）。这些研究涉及全天（最多连续60小时）和夜间的血糖控制，在特定情况下，如简化的餐后控制和运动，以及特定人群例如儿科和低血糖无意识的患者。研究项目在临床研究中心和门诊进行。总体而言，在我们的研究中，AP使目标范围内的时间增加10%至23%，同时使低血糖时间减少4至8倍。与单激素AP相比，双激素AP似乎并没有改善达标时间，但在大多数研究中与进一步降低2至4倍的低血糖风险相关。本研究的目的是比较单激素（胰岛素）AP、双激素（胰岛素和胰高血糖素）AP和低血糖暂停SAP在门诊1型糖尿病成人和儿童中调节昼夜血糖水平的有效性，为期15周。将采用开放标签、多中心、随机设计。该试验之前将进行为期2周的试点研究，以验证自动AP的工程稳健性。这也将使我们能够确认15周研究的把握度计算。为了成功进行这项试验，我们聚集了一个由儿科和成人内分泌学家、工程师、生物统计学家和法规事务专业人员组成的多学科团队。我们还建立了一个多中心试验中心网络。据我们所知，这项研究将是比较单激素AP、双激素AP和SAP与低糖暂停的最大（n=100）随机试验。

项目成果

期刊论文数量（9）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Low-Dose Empagliflozin as Adjunct to Hybrid Closed-Loop Insulin Therapy in Adults With Suboptimally Controlled Type 1 Diabetes: A Randomized Crossover Controlled Trial.

低剂量恩格列净辅助混合闭环胰岛素治疗成人 1 型糖尿病控制不佳：一项随机交叉对照试验。

DOI：
10.2337/dc22-0490
发表时间：
2023
期刊：
Diabetes care
影响因子：
16.2
作者：
Pasqua,Melissa-Rosina;Jafar,Adnan;Kobayati,Alessandra;Tsoukas,MichaelA;Haidar,Ahmad
通讯作者：
Haidar,Ahmad

Perceptions and expectations of adults with type 1 diabetes for the use of artificial pancreas systems with and without glucagon addition: Results of an online survey.