Prospective Quality Improvement Project for High-Risk Diabetes Patients

NCT06472609 | Terminated

• 1 other identifier: N202105025
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Latent Tuberculosis Infection; Continuous Glucose Monitoring; Quality of Life

Keywords

Diabetes Mellitus; Quality of Life; Latent Tuberculosis Infection; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

• quality improvement project

  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 Outcomes (3)

• 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

Study Arms (1)

interactive group

EXPERIMENTAL

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

Behavioral: enhanced interactive education

Interventions

enhanced interactive education BEHAVIORAL

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.

interactive group

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

Chih-Hsin,Lee

Taipei, Taiwan, 106, Taiwan

Location

MeSH Terms

Conditions

Diabetes Mellitus; Latent Tuberculosis

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Diabetic patients have had poor blood glucose control in the past year, and have a record of glycated hemoglobin (HbA1C%) greater than 9%.

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 25, 2024
• Study Start: July 29, 2021
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 22, 2025

Record last verified: 2025-07

Locations

TW (1)