INSULIN ASPART (NOVOLOG) AND LISPRO (HUMALOG) IN INSULIN PUMPS

胰岛素泵中的门冬胰岛素 (NOVOLOG) 和赖脯胰岛素 (HUMALOG)

• 批准号: 7376332
• 负责人: VIVIAN A FONSECA
• 金额: $ 0.99万
• 依托单位: TULANE UNIVERSITY OF LOUISIANA
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-12-01 至 2006-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376332
• 关键词: INSULIN; ASPART; NOVOLOG; LISPRO; HUMALOG

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Insulin pump therapy is now well established as being part of the management strategy for diabetes-especially type 1. However, despite increased efficacy in clinical trial over multiple daily injections, overall glycemic control in patients on pumps has been disappointing compared to injections, overall glycemic controls in patients on pumps has been disappointing compared to injections. One of the reasons for this is that patients do not adhere to advice about changing their pump needles and lines every 48 hours resulting in 1-2 days of suboptimal control. The recommended duration of "needle use" in pump treatment is 48 hours. This recommendation is based on observation of loss of glycemic control after this time period, which is presumed to be due to line/needle obstruction. However, it is possible that the loss of glycemic control may related to instability of insulin in the pump/line due to the associated temperature change, interaction with line materials, etc. This will be an active control, crossover study to: 1. Compare glycemic control between Humalog and Novolog 24 to 100 hours after a pump infusion line change in patients with diabetes treated with pump using a continous glucose monitoring system (CGMS) and daily measurement of serum Glycomark. 2. Compare the post-prandial glycemic excursion in plasma glucose following a standardized breakfast 48, 72, and 96 hours after a line/infusion change. 3. Store blood for future measurement of possible consequences of loss of control by comparing the post-prandial changes in coagulation, inflammation, protein glycation and oxidative stress following a standardized breakfast 48, 72, and 96 hours after a line/insulin change.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。胰岛素泵治疗现在已被公认为糖尿病特别是1型糖尿病管理策略的一部分。然而，尽管临床试验中每日多次注射的疗效增加，但与注射相比，使用泵的患者的总体血糖控制令人失望，使用泵的患者的总体血糖控制令人失望。其中一个原因是患者没有遵守每48小时更换一次泵针和管路的建议，导致1-2天的控制不佳。在泵治疗中，建议的“针头使用”持续时间为48小时。该建议是基于在此时间段后观察到的血糖控制丧失，推测是由于管路/针头阻塞所致。然而，血糖控制丧失可能与胰岛素泵/管路中胰岛素的不稳定性有关，这是由于相关的温度变化、与管路材料的相互作用等。这将是一项活性对照、交叉研究，目的是：1.使用连续血糖监测系统（CGMS）和每日测量血清Glycomark，比较接受胰岛素泵治疗的糖尿病患者在更换胰岛素泵输注管路后24至100小时Humalone和Novolog之间的血糖控制。2.比较管路/输注变更后48、72和96小时标准化早餐后的餐后血糖波动。3.储存血液，以备将来通过比较餐后凝血、炎症、蛋白质糖化和氧化应激的变化来测量失控的可能后果，这些变化是在标准化早餐后48、72和96小时进行的。