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

NCT ID: NCT06331338

Last Updated: 2025-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-14

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Decision Cycle for Person-Centered Glycemic Management

Intervention Type BEHAVIORAL

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

Traditional diabetes self-management education

It is a educator-centered approach to care.

Group Type ACTIVE_COMPARATOR

Traditional diabetes self-management education

Intervention Type OTHER

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

Interventions

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Decision Cycle for Person-Centered Glycemic Management

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

Intervention Type BEHAVIORAL

Traditional diabetes self-management education

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kang-Chih Fan

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University

Locations

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National Taiwan University Hospital

Hsinchu, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chia-Hui Tsai

Role: CONTACT

886926124093

Kang-Chih Fan

Role: CONTACT

886972654308

Facility Contacts

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Chia-Hui Tsai

Role: primary

886926124093

Other Identifiers

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202310085RIND

Identifier Type: -

Identifier Source: org_study_id

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