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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Decision Cycle for Person-Centered Glycemic Management; Other: Traditional diabetes self-management education

Detailed 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 .

• Study Type: Interventional
• Enrollment (Estimated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Hui Tsai; Phone Number: 886926124093; Email: mtsai0322@gmail.com
• Study Contact Backup: Name: Kang-Chih Fan; Phone Number: 886972654308; Email: ntuhendocrine@gmail.com

Study Locations

• Taiwan
  • Hsinchu, Taiwan, 302
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Chia-Hui Tsai; Phone Number: 886926124093; Email: mtsai0322@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New health education:use [Decision Cycle for Person-Centered Glycemic Management ]; It is a person-centered approach to care. Treatment goals and plans should be cotreated with people with diabetes based on their individual preferences, values, and goals.	Behavioral: Decision Cycle for Person-Centered Glycemic Management; It is defined as a purposefully designed holistic care intervention that improve self-management .
Active Comparator: Traditional diabetes self-management education; It is a educator-centered approach to care.	Other: Traditional diabetes self-management education; Traditional diabetes self-management education content focuses more on teaching relevant knowledge and some skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Kang-Chih Fan, National Taiwan University

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Decision Cycle for Person-Centered Glycemic Management; Self-Care Behaviors
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 202310085RIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No