REDEFINING LONG TERM GLYCEMIC CONTROL

重新定义长期血糖控制

• 批准号: 7604680
• 负责人: CHRISTOPHER D. SAUDEK
• 金额: $ 1.11万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-12-01 至 2007-09-16
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604680
• 关键词: Blood; Blood Glucose; Blood Glucose Self-Monitoring; Blood Tests; Caring; Catheters; Child; Complications of Diabetes Mellitus; Computer Retrieval of Information on Scientific Projects Database; Contusions; Daily; Development; Devices; Diabetes Mellitus; Drops; Familiarity; Funding; Future; Glycosylated hemoglobin A; Grant; Health Benefit; Hemorrhage; Infection; Inflammation; Institution; Insulin; Measures; Methods; Monitor; Needles; Pain; Painless; Participant; Patient currently pregnant; Patients; Qualifying; Reporting; Research; Research Personnel; Resources; Risk; Site; Source; Syncope; System; Techniques; Testing; Time; Training; United States National Institutes of Health; Week; Woman; birth control; day; glucose monitor; glycemic control; non-diabetic; sensor; sugar; type I and type II diabetes; volunteer

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. In patients with diabetes, the Hemoglobin A1c blood test value can help predict future development of diabetes complications. A1c has become an important part of diabetes care. This study is being done to find out how the Hemoglobin A1c test value relates to average blood glucose (sugar) over a four month period. How A1c reflects average blood sugar levels will be tested in people with type 1 and type 2 diabetes, and in healthy, non-diabetic volunteers. Volunteers without diabetes are being asked to take part because we also want people with normal, instead of high, blood sugar levels. The average blood sugar values will be estimated over a 16 week period, using several approaches including self monitoring of blood glucose (SMBG) and continuous glucose monitoring system (CGMS), and compared with the A1c, which will be tested monthly. Patients will wear the CGMS device on 4 occasions each seperated by 4 weeks. In addition, patients will monitor their blood gluocse using SMBG 7 times per day, 3 days per week for 16 weeks. The blood glucose values will be compared to the HbA1c values measures every 4 weeks. To qualify for this study, you have to be between 18 and 70 years old, and, if you have diabetes, have a fairly stable level of control, with A1c not varying more than 1% over the last 6 months. About 60 people are expected to take part in this study. There is a risk of pain and/or discomfort felt when the CGMS sensor needle is inserted. This is like injecting yourself with insulin, a momentary prick. Once the sensor is in place it is usually painless, although there may be some discomfort as you use it for two days. Local inflammation at the site of insertion is uncommon. Infection is extremely rare and usually resolves spontaneously when the catheter is replaced. Taking blood may cause pain, bleeding or bruising where the needle is placed. In rare cases, it may result in fainting. There is a small risk of infection. The total amount of blood that will be taken in 4 months time is less than 20 tablespoons. In addition to the needle insertion for the CGMS, the study requires frequent self-monitoring of your blood sugar with fingerstick testing (8 times daily on the two days whe you are using the CGMS, and 7 times daily three times per week when continuous monitoring is not being done). Most people with diabetes find this to be painless or slightly uncomfortable. Fingerstick testing may be more difficult for participants who do not have diabetes, due to lack of familiarity with the technique. To minimize the discomfort, you will use very sharp, small lancets (prickers) with a tiny drop of blood applied to the strip and you will receive careful training at the start of the study. If you are a woman capable of having children, are pregnant, or plan to become pregnant during the course of this study, and if you are not willing to use effective birth control methods, you will not be eligible for the study. There are no definite, direct health benefits to yo if you join this study. If you want to review and discuss the results of your blood sugar testing at the end of the study (or earlier if dangerous results are found), this will be done. If you do not have diabetes, you are not likely to have any benefits from the study. The study may help people with diabetes by fidning out how closely the A1c test reflects average blood sugar. This could clarify the meaning of this test and could cause a change in how A1c results are reported worldwide.

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 在糖尿病患者中，血红蛋白A1 c血液检测值可以帮助预测糖尿病并发症的未来发展。A1 C已成为糖尿病护理的重要组成部分。这项研究正在做，以找出如何血红蛋白A1 c测试值与平均血糖（糖）在四个月的时间。A1 c如何反映平均血糖水平将在1型和2型糖尿病患者以及健康的非糖尿病志愿者中进行测试。没有糖尿病的志愿者被要求参加，因为我们也希望人们有正常的，而不是高血糖水平。将使用几种方法（包括自我血糖监测（SMBG）和动态血糖监测系统（CGMS））估计16周内的平均血糖值，并与A1 c进行比较，A1 c将每月进行一次检测。患者将佩戴CGMS器械4次，每次间隔4周。此外，患者将使用SMBG监测血糖，每天7次，每周3天，持续16周。每4周一次将血糖值与HbA 1c值进行比较。要符合这项研究的资格，您必须在18至70岁之间，并且如果您患有糖尿病，则必须具有相当稳定的控制水平，在过去6个月内A1 c的变化不超过1%。预计约有60人参加这项研究。当插入CGMS传感器针时，存在疼痛和/或不适的风险。这就像给自己注射胰岛素一样，只是一瞬间的刺痛。一旦传感器到位，它通常是无痛的，虽然可能会有一些不适，因为你使用它两天。插入部位的局部炎症并不常见。感染极为罕见，通常在更换导管后自行消退。抽血可能会导致疼痛、出血或针头所在部位的瘀伤。在极少数情况下，它可能会导致昏厥。感染的风险很小。在4个月的时间内，将采取的血液总量不到20汤匙。除了CGMS的针头插入外，本研究还需要通过手指针刺测试频繁自我监测您的血糖（在您使用CGMS的两天内每天8次，在未进行连续监测的情况下每周3次，每天7次）。大多数糖尿病患者发现这是无痛或轻微不舒服。手指针刺测试对于没有糖尿病的参与者来说可能更困难，因为缺乏对该技术的熟悉。为了尽量减少不适，您将使用非常锋利的小刺血针（刺血针），在试纸上滴入一滴血，并且您将在研究开始时接受仔细的培训。如果您是有生育能力的女性，已怀孕或计划在本研究期间怀孕，并且如果您不愿意使用有效的避孕方法，则您将不符合本研究的资格。如果您参加本研究，对您的健康没有明确的直接益处。如果您想在研究结束时（或如果发现危险结果，则更早）审查和讨论您的血糖检测结果，将完成这项工作。如果您没有糖尿病，您不太可能从研究中获益。这项研究可以帮助糖尿病患者找出A1 c测试与平均血糖的关系。这可能会澄清这项测试的意义，并可能导致全球A1 c结果报告方式的变化。