测试版
试验雷达 AI
一个试验符合筛选条件
卡片视图
返回搜索

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring 800

招募中
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT06668935是一项针对糖尿病的观察研究试验，目前试验状态为招募中。试验始于2024年10月24日，计划招募800名患者。该研究由雅培主导，预计于2027年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年1月15日。
简要概括
This study is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) will help prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1/GIP) agonists.
详细描述
Subjects with type 2 diabetes who are newly beginning GLP-1 or GLP-1/GIP drug therapy will be randomized to use either FSL3 or their existing Standard of Care to manage their diabetes. Up to 800 subjects will be enrolled across the United States with 200 evaluable subjects in each group (intervention and control) for a total of 400 evaluable subjects. Subjects will be on the study approximately 210 days. Subjects wil...显示更多
官方标题

Prolongation of GLP-1 Adherence When Using Continuous Glucose Monitoring

疾病
糖尿病
其他研究标识符
  • ADC-US-RES-24254
NCT编号
NCT06668935
实际开始日期
2024-10-24
最近更新发布
2025-01-15
预计完成日期
2027-01
计划入组人数
800
研究类型
观察研究
试验状态
招募中
试验组/干预措施
参与者组/试验组干预措施/治疗方法
Randomization to FSL 3 or Standard of Care
Subjects with type 2 diabetes who are newly beginning GLP-1 or dual GLP-1/GIP drug therapy will be randomized to use either the FSL3 or their existing Standard of Care (SOC) to manage their diabetes.
To utilize the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) to help prolong the length of time people with diabetes maintain adherence to GLP-1 and dual GIP/GLP-1 agonists
All subjects will then begin use of their prescribed GLP-1 or combination GIP/GLP-1 medication in accordance with the HCP's instructions. Subjects will be titrated to their maximum tolerable dose per the medication's approved titration schedule and according to their HCP's standard of care between Visits 2 and 3.
主要终点
结果指标度量标准描述时间框架
To assess the length of time subjects in each group remain on a GLP-1 or GLP-1/GIP combination drug
The primary outcome is to see if the FreeStyle Libre 3 Continuous Glucose Monitoring System (FSL3) helps prolong the length of time people with diabetes maintain adherence to glucagon-like peptide 1 (GLP-1) and dual gastric inhibitory polypeptide/glucagon-like peptide 1 (GIP/GLP-1) agonists.
210 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
  1. Subject must be at least 18 years of age.
  2. Subject must be able to read and understand English.
  3. Subject must have a type 2 diabetes diagnosis.
  4. In the investigator's opinion, subject must meet the criteria for beginning use of GLP-1 or GIP/GLP-1 medications for management of their diabetes.
  5. Subject is beginning use of GLP-1 / GIP/GLP-1 medication for management of their diabetes.
  6. Subject must be willing to allow venous samples to be obtained to test HbA1c.
  7. Subject must be willing to either continue using their existing standard of care device or must be willing to use the FreeStyle Libre 3 Continuous Glucose Monitoring System to manage their diabetes throughout the duration of the study.
  8. In the investigator's opinion, the subject must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
  9. Subject must be available to participate in all study visits.
  10. Subject must be willing and able to provide written signed and dated informed consent.

  1. Subject is a member of the Study Staff.
  2. Subject has a diagnosis of type 1 or gestational diabetes.
  3. Subject is currently using or has previously used GLP-1 or GIP/GLP-1 drugs for any reason.
  4. Subject is currently using a Continuous Glucose Monitor (CGM) as their standard of care device to manage their diabetes.
  5. Subject has known allergy to medical grade adhesive, isopropyl alcohol and/or ethyl alcohol used to disinfect skin.
  6. Subject is taking any type of rapid-acting insulin, including Neutral Protamine Hagedorn (NPH) and premix insulin.
  7. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
  8. Subject currently is participating in another clinical trial.
  9. Subject is unsuitable for participation due to any other cause as determined by the Investigator
Abbott Diabetes Care logo雅培188 个活跃的临床试验可供探索
研究中心联系人
联系人: Mohamed Mohamed Nada, PhD, 5107495416, [email protected]
联系人: Shridhara Karinka, PhD, 510 7495416, [email protected]
2 位于 1 个国家/地区的研究中心

Florida

East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States
Rebecca Goldfaden, Pharm D, 联系人, 904-854-1354, [email protected]
Wasim Deeb, MD, 主要研究者
招募中
Excellence Medical and Research, Miami Gardens, Florida, 33169, United States
Alexander Martinez, OD, 联系人, 786-320-5229, [email protected]
Miguel Trujillo, DNP, 主要研究者
招募中