此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System (STRIVE 2)

2026年7月31日 更新者：Insulet Corporation

Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia

This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Following a 2-week standard therapy phase for baseline data collection, participants will be randomly assigned to the order in which they receive Omnipod 6 or Omnipod 5.

After completion of the first 13-week period, participants will cross-over to the opposite system for an additional 13 weeks. An optional 4-week extension will be offered to all participants to assess the response of the Omnipod 6 System with restricted boluses

研究类型

介入性

注册 (估计的)

200

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

  • 美国
    • California
      • Los Angeles、California、美国、90022
        • 招聘中
        • University of Southern California
        • 接触：
        • 首席研究员：
          • Anne Peters
      • Santa Barbara、California、美国、93105
        • 招聘中
        • Sansum Diabetes Research Institute
        • 首席研究员：
          • Kristin Castorino
        • 接触：
    • Colorado
      • Aurora、Colorado、美国、80045
        • 招聘中
        • University of Colorado
        • 首席研究员：
          • Gregory Forlenza
        • 接触：
    • Connecticut
      • New Haven、Connecticut、美国、06511
        • 招聘中
        • Yale
        • 接触：
        • 首席研究员：
          • Amy Steffen
    • Georgia
      • Atlanta、Georgia、美国、30308
        • 招聘中
        • Emory University
        • 接触：
          • Sabeena Usman
        • 首席研究员：
          • Georgia Davis
    • Illinois
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Northwestern University
        • 首席研究员：
          • Grazia Aleppo
        • 接触：
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • 招聘中
        • Indiana University
        • 首席研究员：
          • Viral Shah
        • 接触：
    • Massachusetts
      • Boston、Massachusetts、美国、02215
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Health Systems
        • 首席研究员：
          • Davida Kruger
        • 接触：
    • Minnesota
      • Minneapolis、Minnesota、美国、55416
        • 招聘中
        • Health Partners
        • 接触：
        • 首席研究员：
          • Amy Criego
    • Texas
      • Houston、Texas、美国、77030
        • 招聘中
        • Baylor College of Medicine
        • 接触：
        • 首席研究员：
          • Daniel DeSalvo

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

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age at time of consent 14-75 years (inclusive)
  • Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment
  • Basal/Bolus insulin delivery via multiple daily doses or insulin pump with or without automation
  • HbA1c ≥ 7.5%
  • Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user
  • Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user
  • Currently using a continuous glucose monitor
  • Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.
  • Participant agrees to provide their own insulin for the duration of the study
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and/or caregiver can safely operate all study devices and can adhere to the protocol
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Willing to wear the system continuously throughout the study
  • Willing and able to sign the Informed Consent Form (ICF) or has a parent/guardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged < 18 years per local regulatory requirements
  • Able to read and understand English and operate the study device in English
  • If of childbearing potential, willing and able to have pregnancy testing

Exclusion Criteria:

  • Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk
  • Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
  • Any planned surgery during the study which could be considered major in the judgment of the investigator
  • History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and/or physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.
  • History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure
  • Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement
  • Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c
  • Use of hydroxyurea
  • Plans to receive blood transfusion over the course of the study
  • Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study
  • Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.
  • Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening
  • Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).
  • Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period
  • Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
  • Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned

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：Omnipod 5 System
设备：Omnipod 5 System
The Omnipod 5 System with the study CGM
实验性的：Omnipod 6 System
设备：Omnipod 6 System
The Omnipod 6 System with the study CGM

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 70-180 mg/dL
大体时间：13 weeks
Change in CGM percent time 70-180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <54 mg/dL
大体时间：13 weeks
Change in CGM percent time <54 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time <70 mg/dL
大体时间：13 weeks
Change in CGM percent time <70 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >180 mg/dL
大体时间：13 weeks
Change in CGM percent time >180 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time in Range 70-140 mg/dL
大体时间：13 weeks
Change in CGM percent time 70-140 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
HbA1c
大体时间：13 weeks
Change in HbA1c (%) between Omnipod 6 and Omnipod 5
13 weeks
Mean sensor glucose
大体时间：13 weeks
Change in mean CGM glucose mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks
Time >250 mg/dL
大体时间：13 weeks
Change in CGM percent time >250 mg/dL compared between Omnipod 6 and Omnipod 5
13 weeks

次要结果测量

结果测量
措施说明
大体时间
Total boluses per day
大体时间：13 weeks
Total blues per day will be compared between Omnipod 6 and Omnipod 5
13 weeks
Total daily insulin per kg and total insulin delivered via automation
大体时间：13 weeks
Total daily insulin per kg and total insulin delivered via automation will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage of time in automated mode
大体时间：13 weeks
Percentage of time in automated mode will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with HbA1c <7.0% and <7.5%
大体时间：13 weeks
Percentage with HbA1c <7.0% and <7.5% will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 70% time in range
大体时间：13 weeks
Percentage with >= 70% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Percentage with >= 50% time in range
大体时间：13 weeks
Percentage with >= 50% time in range will be compared between Omnipod 6 and Omnipod 5
13 weeks
Diabetes treatment satisfaction
大体时间：13 weeks
Patient Reported Outcome with treatment period comparison and baseline to Omnipod 6
13 weeks
System Usability
大体时间：13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
System Opinion
大体时间：13 weeks
Patient Reported Outcome Survey evaluated at the end of each 13-week period
13 weeks
Health Related Quality of Life (HR-QOL)
大体时间：13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Hypoglycemia confidence
大体时间：13 weeks
Patient Reported Outcome Survey with treatment period comparison and baseline to Omnipod 6
13 weeks
Missed Meal - Peak glucose
大体时间：13 weeks
Peak glucose 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - AUC
大体时间：13 weeks
AUC 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Time in Range
大体时间：13 weeks
Time in Range 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 180 mg/dL
大体时间：13 weeks
Percentage of Time > 180 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time > 250 mg/dL
大体时间：13 weeks
Percentage of Time > 250 mg/dL 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <54 mg/dL
大体时间：13 weeks
Percentage of Time <54 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Missed Meal - Percentage of Time <70 mg/dL
大体时间：13 weeks
Percentage of Time <70 mg/dL (NI margin of 0.5%) 4-hours post-prandial compared between Omnipod 6 and Omnipod 5
13 weeks
Number of severe hypoglycemic events
大体时间：13 weeks
13 weeks
Number of DKA or HHS events
大体时间：13 weeks
13 weeks
Other related serious adverse events
大体时间：13 weeks
13 weeks
Unanticipated adverse device effects
大体时间：13 weeks
13 weeks
Reportable device-related adverse events
大体时间：13 weeks
13 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

Insulet Corporation

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13日

初级完成 (估计的)

2027年2月22日

研究完成 (估计的)

2027年3月24日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年8月3日

上次提交的符合 QC 标准的更新

2026年7月31日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STRIVE 2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

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.

订阅