Prospective Quality Improvement Project for High-Risk Diabetes Patients

June 24, 2024 updated by: Taipei Medical University WanFang Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106
        • Recruiting
        • Chih-Hsin,Lee
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: interactive group
diabetes, enhanced interactive education program through weekly phone call for 12 weeks
Behavioral: enhanced interactive education
The present study is a prospective randomized open-label study. Patients with diabetes mellitus who have HbA1c% more than 9% during the recent 1 year are enrolled. The intervention group receives, besides routine medical control of diabetes,enhanced interactive education program through weekly phone call for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
quality improvement project
Time Frame: 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.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune response to tuberculosis-specific antigen.
Time Frame: 12 weeks
In cases of latent tuberculosis infection, Quantiferon-Gold Plus is used to evaluate the immune response of CD8 T cell lymphocytes to tuberculosis-specific antigens before and after treatment.
12 weeks
Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes
Time Frame: 14 weeks
For high-risk diabetic patients receiving treatment for latent tuberculosis infection, use a continuous blood glucose monitor to compare the incidence of adverse events such as hyperglycemia or hypoglycemia five days before and five days after medication.
14 weeks
quality of life measures
Time Frame: 12 weeks
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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

May 26, 2023

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Estimated)

June 25, 2024

Study Record Updates

Last Update Posted (Estimated)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N202105025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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