Clinical trial NCT06472609: Prospective Quality Improvement Project for High-Risk Diabetes Patients
Official title: Prospective Quality Improvement Project for High-Risk Diabetes Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Latent Tuberculosis Infection
Continuous Glucose Monitoring
Quality of Life
Keywords: Diabetes Mellitus
Quality of Life
Latent Tuberculosis Infection
Continuous Glucose Monitoring
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Diabetic patients have had poor blood glucose control in the past year, and have a record of glycated hemoglobin (HbA1C%) greater than 9%.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: quality improvement project
timeFrame: 12 weeks
Secondary outcomes:
measure: Immune response to tuberculosis-specific antigen.
timeFrame: 12 weeks
measure: Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes
timeFrame: 14 weeks
measure: quality of life measures
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Chih-Hsin,Lee
Study officials:
References: