Diabetes MellitusNCT06472609
Prospective Quality Improvement Project for High-Risk Diabetes Patients
A study testing enhanced interactive education in people with Diabetes Mellitus and Latent Tuberculosis Infection, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Latent Tuberculosis Infection, Continuous Glucose Monitoring
- What is being tested?
- enhanced interactive education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Jul 2021to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diabetic patients had a record of glycated hemoglobin (HbA1C%) greater than 9% in the past year.
Who cannot join
- Be younger than 20 years old.
- Unconsciousness or severe dementia, unable to conduct quality of life questionnaire assessment.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Latent Tuberculosis Infection, Continuous Glucose Monitoring, Quality of Life
- Being tested
- enhanced interactive education
- Keywords
- Diabetes Mellitus, Quality of Life, Latent Tuberculosis Infection, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
enhanced interactive educationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| interactive group | Experimental | diabetes, enhanced interactive education program through weekly phone call for 12 weeks Receives: Behavioral: enhanced interactive education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
Immune response to tuberculosis-specific antigen.
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.
Measured: 12 weeks
Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes
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.
Measured: 14 weeks
quality of life measures
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start29 Jul 2021
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Why it stopped: Close-out meeting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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%.
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472609
- Sponsor's protocol ID
- N202105025
- Status last verified
- Jul 2025
- First submitted
- 26 May 2023
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Quality Improvement Project for High-Risk Diabetes Patients
- ClinicalTrials.gov ID
- NCT06472609
- Acronym / sponsor ID
- N202105025
- Conditions
- Diabetes Mellitus, Latent Tuberculosis Infection, Continuous Glucose Monitoring, Quality of Life
- Keywords
- Diabetes Mellitus, Quality of Life, Latent Tuberculosis Infection, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Close-out meeting
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 29 Jul 2021 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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%.
| Arm | Type | Receives |
|---|---|---|
| interactive group | Experimental | Behavioral: enhanced interactive educationdiabetes, enhanced interactive education program through weekly phone call for 12 weeks |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diabetic patients had a record of glycated hemoglobin (HbA1C%) greater than 9% in the past year.
Key exclusion criteria (2 listed)
- Be younger than 20 years old.
- Unconsciousness or severe dementia, unable to conduct quality of life questionnaire assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| enhanced interactive educationThe 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. | Behavioural | interactive group |
Primary outcome
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.
3 secondary outcomes
Immune response to tuberculosis-specific antigen.
Time frame: 12 weeks
Number of episodes of hyperglycemia or hypoglycemia in people with high-risk diabetes
Time frame: 14 weeks
quality of life measures
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Close-out meeting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing enhanced interactive education in people with Diabetes Mellitus and Latent Tuberculosis Infection, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Close-out meeting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality improvement project (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.