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Recruiting NCT06331338

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

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Decision Cycle for Person-Centered Glycemic Management, Traditional diabetes self-management education.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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

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 .

Interventions

  • 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.

Primary outcome measures

  • glycemic control (HbA1c) [Time frame: Before the task and 3 months post intervention]
Secondary outcome measures (1)
  • Diabetes Self-Care Behavior Scale [Time frame: Before the task and 3 months post intervention]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital — Hsinchu

Identifiers

NCT: NCT06331338 · 202310085RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗