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临床试验/NCT06472609
NCT06472609终止不适用

Prospective Quality Improvement Project for High-Risk Diabetes Patients

Taipei Medical University WanFang Hospital1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2021年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
149
试验地点
1
主要终点
quality improvement project

研究概览

简要总结

Diabetes is the most important comorbidity of tuberculosis patients in Taiwan, and 1/4 of tuberculosis patients also It is a diabetic patient, and the treatment of latent tuberculosis infection is currently an important policy of the Taiwan Disease Control Agency One, because babies are prone to encounter difficulties in the early stages, because of the spread of Australian patients in the community, The Department of Disease Control encourages patients with diabetes to receive screening and treatment for latent tuberculosis infection.

详细描述

Diabetes mellitus is the most prevalent comorbiditiy for patients with active tuberculosis in Taiwan. More than one fourth of the patients with incident tuberculosis has diabetes mellitus. The latent tuberculosis infection treatment is recommended by the Centers of Disease Control (CDC) of Taiwan to halt the transmission of tuberculosis in the community. Considering a relatively long delay in diagnosis of tuberculosis in clinical practice, eliminate the dormant tuberculosis germs a the stage of latent infection is the most cost-effective strategy to avoid tuberculosis transmission. The population with diabetes mellitus and inadequate blood sugar control are at increased risk of latent tuberculosis infection and activation and are encouraged to undergo latent tuberculosis screening and treatment. However, the anti-tuberculosis agents could have significant drug-drug interaction with the drugs used for diabetes mellitus control. The extent of its impact on blood sugar is still unclear. We aim to investigate the fluctuation of blood sugar during latent tuberculosis treatment with continuous subcutaneous sugar monitoring device to evaluate the possible associated risk of hyperglycemia or hypoglycemia to enhance treatment safety. Inadequate blood sugar control is the root for immune dysfunction and render the patients vulnerable to infectious diseases. Hence, improvement in the blood sugar control not only leads to a better immune function to avoid tuberculosis infection but also reduce the risk of progression for cardiovascular and renal disorder. The present study proposed a protocol of 12-week aggressive blood sugar control and education program using phone call to improve the blood sugar control and life quality. Furthermore, to evaluate the efficacy of anti-tuberculosis treatment for latent tuberculosis, we propose to evaluate the mycobacteria-specific antigen immune response by using the interferon-gamma releasing assay before and after anti-tuberculosis treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Diabetic patients had a record of glycated hemoglobin (HbA1C%) greater than 9% in the past year.

排除标准

  • •Be younger than 20 years old.
  • •Unconsciousness or severe dementia, unable to conduct quality of life questionnaire assessment.

研究组 & 干预措施

interactive group

Experimental

diabetes, enhanced interactive education program through weekly phone call for 12 weeks

干预措施: enhanced interactive education (Behavioral)

结局指标

主要结局

quality improvement project

时间窗: 12 weeks

After the admitted patients were involved in the quality improvement project, the glycated blood demand in the 12 weeks was tracked as the target index for purposeful control and research, and the final value was compared. The quality of life of the case was evaluated by using the Diabetes-Related Distress Questionnaire (DRDQ) as an evaluation index to compare the differences before and after the intervention of the interdisciplinary care team.

次要结局

  • Immune response to tuberculosis-specific antigen.(12 weeks)
  • Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes(14 weeks)
  • quality of life measures(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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