REDEFINING LONG TERM GLYCEMIC CONTROL

点击翻译按钮获取中文摘要

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.