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[试验性设备,未经美国FDA批准或认证] (INSIGHT)

2026年6月17日 更新者:Sue Brown

[美国食品药品监督管理局(FDA)未批准或未认证的设备试验]

This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.

研究概览

详细说明

The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).

The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.

研究类型

介入性

注册 (估计的)

20

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • Virginia
      • Charlottesville、Virginia、美国、22903
        • 招聘中
        • University of Virginia Center for Diabetes Technology
        • 副研究员:
          • Mark DeBoer, MD
        • 副研究员:
          • Samina Afreen, MD
        • 副研究员:
          • Marcela Moscoso-Vasquez, PhD
        • 接触:
        • 副研究员:
          • Driscoll Kimberly, PhD

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Participant Inclusion Criteria

  1. Age ≥18.0 years old at time of consent
  2. Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
  3. Having used an FDA approved AID system within the last 6 months (can be intermittent use).
  4. Currently using insulin for >6 months.
  5. Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
  6. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
  7. Participant not currently known to be pregnant or breastfeeding.
  8. If participant can become pregnant, they must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all participants of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  9. Willingness to wear a Dexcom CGM during each of the study phases.
  10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
  11. Willingness not to start any new non-insulin glucose-lowering agent during the trial.
  12. Willingness to participate in all study procedures including in person training.
  13. Access to internet at home and willingness to upload data during the study as needed.
  14. Investigator has confidence that the participant can successfully operate all study devices and can adhere to the protocol.
  15. Participant is proficient in reading and verbal communication in English.

Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.

  1. Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
  2. Current use of sulfonylurea medications.
  3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
  4. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
  5. Hemophilia or any other bleeding disorder.
  6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
  7. History of DKA event in the last 12 months.
  8. Currently on peritoneal or hemodialysis.
  9. Currently being treated for adrenal insufficiency.
  10. Currently being treated for a seizure disorder.
  11. Hypothyroidism or hyperthyroidism that is not adequately treated.
  12. Use of oral or injectable steroids at the time of enrollment.
  13. Known ongoing adhesive intolerance that is not well managed.
  14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
  15. Participation in another interventional trial at the time of enrollment.
  16. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group A: AID first followed by AIDANET+ACL then AIDANET+FCL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL)
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
有源比较器:Group B: AID first followed by AIDANET+FCL then AIDANET+ACL
Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL).
Usual Care
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time in range 70-140 mg/dL as computed by the study CGM
大体时间:8 weeks
Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
8 weeks
Time in range 70-140 mg/dL as computed by the study CGM
大体时间:8 weeks

Outcome is computed if:

  • >4032 values are recorded (availability condition, 2 weeks equivalent)
  • AND there is >70% values between the first recorded EGV of the analysis window and the last (density condition)
8 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Sue A Brown, MD、University of Virginia Center for Diabetes Technology

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月14日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年3月27日

首先提交符合 QC 标准的

2026年3月27日

首次发布 (实际的)

2026年4月2日

研究记录更新

最后更新发布 (实际的)

2026年6月22日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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