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临床试验 NCT04230694 针对糖尿病，糖尿病，高血糖，Glucose, Low Blood目前进行中（不再招募）。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes 40
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临床试验NCT04230694是一项针对糖尿病，糖尿病，高血糖，Glucose, Low Blood的干预性研究试验，目前试验状态为进行中（不再招募）。试验始于2021年9月20日，计划招募40名患者。该研究由Baylor Research Institute主导，预计于2024年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2024年12月3日。
简要概括
Systematic continuous glucose monitoring (CGM) is commonly provided as a treatment option to patients with diabetes in ambulatory care settings yet is rarely provided during hospitalization. CGM of inpatients has the potential to be the care delivery innovation that is feasible, cost effective and can improve glucose control, especially by reducing hypoglycemic events. Studies of CGM use in the ICU setting have been ...显示更多
详细描述
AIM
1) Test the health impact of CGM of inpatients as defined by rates of hypo- and hyperglycemia and the derivative of time in appropriate glucose range. Forty (40) patients will be randomized 1:1 into one of two conditions. In the treatment condition, patients will receive a Dexcom Gen6 device and the clinical staff (i.e., nursing and medical staff assigned to the patient's care) will be trained to use readings f...
显示更多官方标题
Continuous Glucose Monitoring of Hospitalized Patients With Diabetes: A Pilot Study to Establish Evidence
疾病
糖尿病糖尿病高血糖Glucose, Low Blood出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- 018-601
NCT编号
实际开始日期
2021-09-20
最近更新发布
2024-12-03
预计完成日期
2024-12-31
计划入组人数
40
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
进行中（不再招募）
关键词
diabetes
主要目的
诊断
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照Control Group Control Group subjects will wear the CGM device during their hospitalization, up to 10 days, but glucose readings will NOT be continuously monitored. Control Group subjects will have their glucose management guided by routine standard of care finger sticks. The readings from the CGM device are recorded and reviewed retrospectively, but not used for glucose management during the hospital stay. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
实验性Treatment Group Treatment Group subjects will wear the CGM device during their hospitalization, up to 10 days, and glucose readings WILL be continuously monitored. Treatment Group subjects will have their glucose management guided by readings from the CGM device and standard of care finger sticks. | Dexcom Generation 6 CGM (Dexcom Gen6) device Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of Hypoglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of Hyperglycemia Events during hospitalization | Dexcom Gen6 readings | Up to 10 days |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Patients with Type 1 and Type 2 diabetes.
- Subjects 18 years of age or older with diabetes.
- Subjects willing to avoid using high dose acetaminophen (defined as greater than 4 gm per day)
- Subjects with expected hospital length-of-stay of 2 or more days beyond the time of enrollment.
- Subjects willing to wear CGM device.
- Female subjects who are pregnant or lactating at the time of enrollment into the study. Females with childbearing potential will be queried about the possibility of pregnancy and a serum pregnancy test will be performed.
- Subjects with greater than 4gm use of Tylenol/24 hr.
- Surgical patients or patients with pre-planned surgery or procedure in the next 48 hours.
- Subjects with acute illness admitted to the ICU or expected to require admission to the ICU.
- Patients who may potentially require IV insulin.
- Patients with skin lesions, severe psoriasis, burns, tattoos, scarring, redness, infection or edema at the application sites that could interfere with device placement or the accuracy of interstitial glucose measurements.
- Patient with a known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
- Patients who have had organ transplant.
- Patients with any severe medical conditions such as end-stage renal disease on dialysis, status post renal transplantation, end-stage liver disease with diffuse anasarca, heart failure on inotropic support, Ejection Fraction (EF) < 15 % or severe sepsis.
- Any condition for which, in the opinion of the investigators, it would not be in the best interest of the participant.
- Legally protected subjects (under judicial protection, guardianship, or supervision), persons deprived of their liberty, mental or language barriers rendering the subject unable to understand the nature, scope and possible consequences of the study.
- Subjects with active substance abuse.
- Subjects with infaust prognosis.
Baylor Research Institute没有联系数据。
1 位于 1 个国家/地区的研究中心
Texas
Baylor Scott & White Medical Center - Temple, Temple, Texas, 76508, United States