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NCT Number: NCT06331338

Effects of Using Decision Cycle for Person-Centered Glycemic Management in 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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Hospital

Hsinchu, 302, Taiwan

Location status: Recruiting

Location contact

Chia-Hui Tsai

CONTACT

[email protected]

886926124093

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with type 2 diabetes by a physician.
  • Age: 18 years or above.
  • Glycated hemoglobin (HbA1c ) test value: 7.5-9.0 %
  • No diabetic oral medications, insulin and glucagon-like peptide-1 were replaced in the outpatient when the case was admitted.
  • No pregnancy during the study period.
  • After the researcher explains the purpose of the research, the research subjects agree to join this researcher.
  • Those who are conscious and able to take care of themselves.
  • There is no diagnostic certificate from the American Psychiatric Association's Diagnostic Manual of Mental Disorders, Fourth Edition (DSM-IV)of all mental illnesses.
  • Those who can communicate in Mandarin and Taiwanese.

Exclusion criteria

  • Patients diagnosed with type 1 diabetes by a physician.
  • Age: Under 18 years old.
  • Glycated hemoglobin test value: less than 7.5 % and greater than 9.0 %
  • Those who replaced oral diabetes medications, insulin and glucagon-like peptide- 1 at the outpatient at the time of admission.
  • Pregnancy during the study period.
  • Those who are unable to take care of themselves and express themselves.

Treatment and study plan

Decision Cycle for Person-Centered Glycemic Management

Behavioral

It is defined as a purposefully designed holistic care intervention that improve self-management .

Traditional diabetes self-management education

Other

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

Primary outcomes

  1. glycemic control (HbA1c)

    Time frame: Before the task and 3 months post intervention

    The HbA1c level is a marker of the average blood glucose levels over a period of the last 2-3 months.

Secondary outcomes

  1. Diabetes Self-Care Behavior Scale

    Time frame: Before the task and 3 months post intervention

    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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Chia-Hui Tsai

CONTACT

[email protected]

886926124093

Kang-Chih Fan

CONTACT

[email protected]

886972654308

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 26, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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