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

NCT06331338 | Recruiting

• 1 other identifier: 202310085RIND
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Decision Cycle for Person-Centered Glycemic Management; Self-Care Behaviors; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diabetes Self-Care Behavior Scale

  Before the task and 3 months post intervention

Study Arms (2)

New health education:use [Decision Cycle for Person-Centered Glycemic Management ]

EXPERIMENTAL

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

Traditional diabetes self-management education

ACTIVE COMPARATOR

It is a educator-centered approach to care.

Other: Traditional diabetes self-management education

Interventions

Decision Cycle for Person-Centered Glycemic Management BEHAVIORAL

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

New health education:use [Decision Cycle for Person-Centered Glycemic Management ]

Traditional diabetes self-management education OTHER

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

Traditional diabetes self-management education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Hsinchu, 302, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kang-Chih Fan

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chia-Hui Tsai

CONTACT

886926124093; mtsai0322@gmail.com

Kang-Chih Fan

CONTACT

886972654308; ntuhendocrine@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: February 14, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)