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Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes (MODIUS)

2026年8月27日 更新者：DreaMed Diabetes
A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

102

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。

学习地点

  • 美国
    • Maryland
      • Baltimore、Maryland、美国、21201
        • 尚未招聘
        • Baltimore VA Medical Center Univ of Maryland
        • 接触：
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Health System
        • 接触：
        • 首席研究员：
          • Davida Kruger
    • New York
      • Albany、New York、美国、12246
        • 招聘中
        • SUNY Upstate Medical Center
        • 接触：
        • 首席研究员：
          • Malek El Muayed, MD
    • North Carolina
      • Morehead City、North Carolina、美国、28557
    • Texas
      • Austin、Texas、美国、78731
        • 招聘中
        • Texas Diabetes & Endocrinology
        • 首席研究员：
          • Thomas Blevins, MD
        • 接触：
    • Utah
      • Sandy City、Utah、美国、84093
        • 招聘中
        • Diabetes & Endocrine Treatment Specialisits (DETS)
        • 首席研究员：
          • Timothy Graham, MD
        • 接触：

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

Inclusion Criteria:

  1. Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent

  2. Insulin therapy as follows:

    1. If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking

      1 basal insulin injection per day for at least 1 week prior to screening

    2. If T2D, either:

    i. not using insulin in the 3 months prior to screening, but require initiation of a basal-only insulin regimen based on investigator assessment ii. using only basal insulin for at least 3 months prior to screening and taking 1 basal insulin injection per day for at least 1 week prior to screening iii. using MDI for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either

    (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) mealsize-based dosing (small, normal, large); and taking 1 basal insulin injection per day for at least 1 week prior to screening

  3. Age at time of consent 18-80 years
  4. HbA1c >7.5% and <12% as measured by point-of-care device or local lab at the time of screening
  5. Using only injected insulin types that are specified in the MODI Instructions for Use materials
  6. Stable doses of non-insulin glucose lowering medications over the 4 weeks preceding screening as determined by Investigator and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  7. Stable doses of weight loss medications that may have a meaningful effect on glycemic control over the 4 weeks preceding screening and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  8. Weight between 80 - 440 lb at the time of screening
  9. Willing to use FSL 3 System according to manufacturer instructions and to avoid use of any other personal CGM system during the period of study participation
  10. Willing to document insulin delivery, meals, and daily activities in the Diary mobile app
  11. Has a smartphone compatible with study requirements: either iOS version 17.0 or higher, or Android version 10.0 or higher, and willing to install required apps and use them as instructed during the period of study participation, with internet connectivity for a data upload at least once per day.
  12. Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment
  13. Investigator has confidence that the participant has the cognitive ability necessary for study participation, can successfully operate all study devices, and can adhere to the protocol
  14. Has a sufficient understanding of written/spoken English for legally effective informed consent and successful use of the study mobile apps
  15. If woman of childbearing potential, is willing and able to have pregnancy testing

Exclusion Criteria:

  1. Use of an insulin pump within 3 months prior to informed consent
  2. Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening
  3. Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening
  4. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
  5. Current or known history of coronary artery disease that is not stable with medical management, 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
  6. Any planned surgery during the study which could be considered major in the judgment of the investigator
  7. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
  8. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening
  9. Blood disorder or dyscrasia within 3 months prior to screening which in the investigator's opinion could interfere with determination of HbA1c
  10. Any condition or intervention that may affect red blood cell turnover, in the 3 months prior to the study and during the study, such as blood transfusion or donation
  11. Has taken oral or injectable corticosteroids within 2 weeks prior to screening or plans to take oral or injectable corticosteroids during the study
  12. 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
  13. Is an employee of DreaMed Diabetes, is a study Investigator or a member of the Investigator's study team, or is immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
  14. Participation in another clinical study using an investigational drug or device in the 90 days prior to screening or intends to participate during the study period
  15. Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months postmenopausal)
  16. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact the CGM sensor

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：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MODI dose guidance, insulin titration application
设备：MODI Algorithm
All participants use MODI insulin titration algorithm. Includes Diary app used to view treatment plans shared by MODI and manually log events (insulin intake, meal, physical activity and others) by participants; also includes a bolus calculator.

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
CGM-measured percent time <54mg/dL
大体时间：13 weeks
Change in CGM-measured percent time <54 mg/dL from 2 weeks of baseline to 4 weeks prior to the dose guidance week 12 visit (non-inferiority with margin 0.5%)
13 weeks

次要结果测量

结果测量
措施说明
大体时间
HbA1c
大体时间：13 weeks
Change in HbA1c from baseline to dose guidance week 12 visit
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

DreaMed Diabetes

合作者

Jaeb Center for Health Research
Abbott Diabetes Care

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25日

初级完成 (估计的)

2027年1月1日

研究完成 (估计的)

2027年1月1日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年8月28日

上次提交的符合 QC 标准的更新

2026年8月27日

最后验证

2026年5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

  • CL-1644

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.

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