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

• 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
• 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
• 来源: https://reporter.nih.gov/project-details/8975051
• 关键词: Address; Adipose tissue; Adolescent; Adult; Area Under Curve; Artificial Pancreas; Back; Blindness; Blood; Blood Pressure; Body Composition; Child; Childhood; Clinical Research; Development; Effectiveness; Endocrinologist; Energy Intake; Energy Metabolism; Engineering; Enzymes; Event; Exercise; Failure; Fright; Glucagon; Glucose; Glycosylated hemoglobin A; Goals; Health; Heart Diseases; Heart Rate; Hormones; Hour; Hypoglycemia; Inpatients; Insulin; Insulin Infusion Systems; Insulin-Dependent Diabetes Mellitus; Interview; Kidney Failure; Lead; Lipids; Liver; Measures; Morphology; Multicenter Trials; Outcome; Outpatients; Patients; Performance; Physical activity; Pilot Projects; Population; Potassium; Pump; Quality of life; Questionnaires; Randomized; Recruitment Activity; Regulatory Affairs; Renal function; Research; Research Project Grants; Rest; Risk Reduction; Sample Size; Secure; Site; Sleep; Technology; Testing; Time; base; blood glucose regulation; compare effectiveness; design; eligible participant; expectation; glucose sensor; hypoglycemia unawareness; improved; multidisciplinary; open label; operation; pediatric patients; prevent; primary outcome; programs; public health relevance; randomized trial; secondary outcome; sensor; trial comparing

 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（通过应用程序证明）：在受控的注册中，许多研究证明了盛宴的AP poglycemia和降低的平均葡萄糖水平。小组正在比较传感器的泵治疗（SAP）和AP提供的胰岛素。 1将不久（包括50名儿科患者）在720天内进行测试。 与糖尿病相比，小儿和低血糖的患者在我们的研究中均增加了10％至23％的低血糖。到4倍额外的降血糖风险降低。 。生物统计学家和一些报告专业人士。

项目成果

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

Neuroessentialism in Discussions About the Impact of Closed-Loop Technologies on Agency and Identity.

关于闭环技术对代理和身份影响的讨论中的神经本质主义。

• DOI: 10.1080/21507740.2017.1320328
• 发表时间: 2017
• 期刊: AJOB neuroscience
• 作者: Racine,Eric;Quintal,Ariane;Sample,Matthew
• 通讯作者: Sample,Matthew

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.

• DOI: 10.1016/j.numecd.2020.10.006
• 发表时间: 2021-02-08
• 期刊: Nutrition, metabolism, and cardiovascular diseases : NMCD
• 作者: Taleb N;Quintal A;Rakheja R;Messier V;Legault L;Racine E;Rabasa-Lhoret R
• 通讯作者: Rabasa-Lhoret R

A Randomized Crossover Pilot Study Evaluating Glucose Control During Exercise Initiated 1 or 2 h After a Meal in Adults with Type 1 Diabetes Treated with an Automated Insulin Delivery System.

一项随机交叉试点研究，评估接受自动胰岛素输送系统治疗的 1 型糖尿病成人饭后 1 或 2 小时开始运动期间的血糖控制。

• DOI: 10.1089/dia.2022.0338
• 发表时间: 2023
• 期刊: Diabetes technology & therapeutics
• 影响因子: 5.4
• 作者: Myette-Côté,Étienne;Molveau,Joséphine;Wu,Zekai;Raffray,Marie;Devaux,Marie;Tagougui,Sémah;Rabasa-Lhoret,Rémi
• 通讯作者: Rabasa-Lhoret,Rémi

A qualitative study exploring the expectations of people living with type 1 diabetes regarding prospective use of a hybrid closed-loop system.

• DOI: 10.1111/dme.14309
• 发表时间: 2020-11
• 期刊: Diabetic medicine : a journal of the British Diabetic Association
• 作者: Quintal A;Messier V;Rabasa-Lhoret R;Racine E
• 通讯作者: Racine E