Effects of Using Decision Cycle for Person-Centered Glycemic Management in Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Research on the Effectiveness of Using Decision Cycle for Person-Centered Glycemic Management on Self-Care Behaviors in Outpatients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331338
• Other study ID #: 202310085RIND
• Status: Recruiting
• Phase: N/A
• Start date: February 14, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: National Taiwan University Hospital
• Contact: Chia-Hui Tsai
• Phone: 886926124093
• Email: mtsai0322[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Decision cycle for person-centered glycemic management is a new diabetes decision making .It is defined as a purposefully designed holistic care intervention .The goal is to improve the self-care behavior of patients with type 2 diabetes, thereby improving glycated hemoglobin levels and delaying the occurrence of complications.

Description:

The "Decision Cycle for Person-Centered Glycemic management" jointly proposed by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) in 2018 , which develops treatment goals and plans based on the patient's personal preferences, values, and goals. Participants will be divided into two groups(treatment group 、control group).Treatment group will accept the "Decision Cycle for Person-Centered Glycemic Management " .It is a person-centered diabetes decision making. Control group will accept the traditional diabetes self-management education. It content focuses more on teaching relevant knowledge and some skills.It is a educator-centered approach. Baseline / pre-intervention test (after signing informed consent form) post-intervention test (after finishing intervention) Researchers will compare treatment group and control group to see if treatment group has better performance on self-care Behaviors and glycated hemoglobin levels .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes by a physician.

2. Age: 18 years or above.

3. Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %

4. No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.

5. No pregnancy during the study period.

6. After the researcher explains the purpose of the research, the research subjects agree to join this researcher.

7. Those who are conscious and able to take care of themselves.

8. There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.

9. Those who can communicate in Mandarin and Taiwanese.

Exclusion Criteria:

1. Patients diagnosed with type 1 diabetes by a physician.

2. Age: Under 18 years old.

3. Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %

4. Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.

5. Pregnancy during the study period.

6. Those who are unable to take care of themselves and express themselves.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Decision Cycle for Person-Centered Glycemic Management
It is defined as a purposefully designed holistic care intervention that improve self-management .

Other:
• Traditional diabetes self-management education
Traditional diabetes self-management education content focuses more on teaching relevant knowledge and some skills.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Hsinchu

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycemic control (HbA1c)	The HbA1c level is a marker of the average blood glucose levels over a period of the last 2-3 months.	Before the task and 3 months post intervention
Secondary	Diabetes Self-Care Behavior Scale	It is contains 20 likert-scaled (1-5) items, it assessed the frequency with which patients performed the diabetes self-care behaviors, including how often took diabetes medications, exercise, blood glucose monitor, diet . A higher score indicates greater self care behavior .	Before the task and 3 months post intervention