Effects of a Researcher-Designed Diabetes Self-Management App on Self-Management Obstacles, Self-Efficacy, and Physiological Indicators in Type 2 Diabetes

N/ANot Yet RecruitingNCT07794384

Fu Jen Catholic University Hospital80 enrolled

Overview

This study aims to evaluate the effectiveness of a self-developed diabetes self-management mobile application on disease self-management outcomes among individuals with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)Self-management

Interventions

Researcher-Designed Diabetes Self-Management ApplicationBEHAVIORAL

Participants in the intervention group will receive routine diabetes care and use the enhanced diabetes self-management mobile application. In addition to the basic self-management recording functions, the intervention group will receive video-based health education and multidisciplinary team care through the application. The multidisciplinary team may include healthcare professionals such as physicians, nurses, dietitians, and pharmacists, who provide diabetes-related guidance to support daily self-management, self-efficacy, and metabolic control.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed with type 2 diabetes for more than 6 months and Hemoglobin A1c (HbA1c) \> 7.5%. * Having diabetes self-management obstacles. * Aged 18 years or older. * Conscious and able to communicate. * Having a smartphone with internet access. * Willing to participate in the study and provide written informed consent. Exclusion Criteria: * Gestational diabetes mellitus. * Currently taking steroid medications. * Having a severe infection requiring hospitalization within the past 6 months. * Unable to perform self-care independently. * Having participated in or currently participating in an educational program of a similar nature.

Outcomes

Primary Outcomes

Diabetes management self-efficacy

1. The Chinese version of the Diabetes Management Self-Efficacy Scale(C-DMSES) includes 20 items across four subscales: 1. Nutrition: 9 items 2. Physical activity and weight control: 4 items 3. Medication treatment: 3 items 4. Blood glucose and foot care: 4 items 2. Scores range from 0 to 10. 3. The scale has good reliability, with an overall Cronbach's α of .93. 4. Subscale Cronbach's α values range from .77 to .93. 5. The scale also has good test-retest reliability, with Pearson's r = .86, p \< .01.

Time frame: Baseline, 3 months, and 6 months.

Diabetes self-management obstacles

Diabetes self-management obstacles will be measured using the Chinese Version of the Diabetes Obstacles Questionnaire-Short Form (CDOQ-S). Each item is rated on a 5-point Likert scale, ranging from 1 to 5. The items are negatively scored, and higher scores indicate greater obstacles in diabetes self-management.

Time frame: Baseline, 3 months, and 6 months.

Secondary Outcomes

HbA1c

Glycated hemoglobin (HbA1c) will be measured using laboratory blood tests and reported as a percentage (%)

Time frame: Baseline, 3 months, and 6 months

Fasting plasma glucose

Fasting plasma glucose will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).

Time frame: Baseline, 3months, and 6months

Triglycerides

Serum triglyceride levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).

Time frame: Baseline, 3months, and 6 months

Total cholesterol

Serum total cholesterol levels will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).

Data from ClinicalTrials.gov

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