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加强 T2D 远程医疗的试点研究

2026年11月3日 更新者:Margaret Zupa、University of Pittsburgh

加强对复杂 2 型糖尿病成人患者的远程医疗护理服务的试点研究

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is:

Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible?

Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes.

Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

研究概览

详细说明

This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.

Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.

The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.

研究类型

介入性

注册 (实际的)

43

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

    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • University of Pittsburgh

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

18年 至 80年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • adults 18 years or older
  • Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
  • HbA1c greater than or equal to 8% based on most recent value at time of recruitment
  • Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
  • Patient must use insulin
  • Patients must have >2 comorbid chronic health conditions
  • Be able to provide informed consent
  • Reside in Pennsylvania

Exclusion criteria:

  • Age over 80 based on date of birth in electronic medical record

  • Visit with an endocrinologist in the prior 1 years

  • Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition

    • Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
    • Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
    • ESRD N18.6
  • Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition

    • Type 1 diabetes: E10.X
    • Gestational diabetes: O24.X, E08.X
    • Other diabetes: E09.X, E13.2
  • Pregnant or planning to become pregnant in next 6 months

  • Currently enrolled in another diabetes management intervention study

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:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 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:Enhanced Telemedicine Care

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team.

Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up.

有源比较器:Usual Care

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.

Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis.

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
Recruitment percentage
大体时间:12 months

Percent of eligible patients approached who are enrolled

12 months
Loss to follow up
大体时间:6 months

Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys

6 months

次要结果测量

结果测量
措施说明
大体时间
Recruitment rate
大体时间:12 months

Number of patients recruited per month

12 months
Eligibility percentage
大体时间:12 months

Percent of patients approached who are eligible

12 months
Visit attendance
大体时间:6 months

Percent of scheduled visits completed per patient

6 months
Number of between-visit contacts
大体时间:6 months

Number of successful and attempted patient contacts by clinicians between visits per patient

6 months
Blood glucose data availability
大体时间:6 months

Number of telemedicine visits with blood glucose data available at visit per patient

6 months
Patient satisfaction with telemedicine diabetes care
大体时间:6 months

Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction

6 months
Diabetes Treatment Satisfaction Questionnaire-static version
大体时间:Baseline

Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems.

Baseline
Diabetes Treatment Satisfaction Questionnaire-change version
大体时间:6 months

Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now').

Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before.

6 months
T2D Diabetes Distress Core Scale
大体时间:Baseline and 6 months

Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress.

Baseline and 6 months
HbA1c change
大体时间:Baseline and 6 months

Change in glycemic control from baseline to 6 months

Baseline and 6 months
Prescription of guideline-based GLP-1 receptor agonist
大体时间:Baseline and 6 months

Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication

Baseline and 6 months
Prescription of guideline-based SGLT2 inhibitor
大体时间:Baseline and 6 months

Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication

Baseline and 6 months
Retinal examination
大体时间:6 months

Number of patients with documentation of retinal examination performed in last year in medical record

6 months
Urine protein testing
大体时间:6 months

Number of patients with documentation of urine protein testing performed in last year in medical record

6 months
Immunization-pneumococcal
大体时间:6 months

Number of patients with documentation of pneumococcal vaccination in medical record

6 months
Immunization-influenza
大体时间:6 months

Number of patients with documentation of influenza vaccination in medical record

6 months

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。

调查人员

  • 首席研究员:Margaret Zupa, MDMS、University of Pittsburgh

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)

2025年2月3日

初级完成 (估计的)

2027年1月30日

研究完成 (估计的)

2027年1月30日

研究注册日期

首次提交

2024年12月13日

首先提交符合 QC 标准的

2024年12月13日

首次发布 (实际的)

2024年12月18日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • STUDY24060062
  • K23DK135794 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.

IPD 共享时间框架

The data will become available no later than 12 months and ending 36 months after the primary trial results are published.

IPD 共享访问标准

No access will be granted until the requesting investigator vetting process is completed including an IRB-approved protocol and data use agreement with the University of Pittsburgh.The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

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

不

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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