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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFu Jen Catholic University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Gestational diabetes mellitus.

Currently taking steroid medications.

Having a severe infection requiring hospitalization within the past 6 months.

Unable to perform self-care independently.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Researcher-Designed Diabetes Self-Management Application

    Behavioral

    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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Basic self-management mobile application use.No intervention 0 interventions
Group B: Enhanced diabetes self-management mobile application use.Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.
2

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

1

HbA1c

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

Time frame
Baseline, 3 months, and 6 months
2

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
3

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
4

Total cholesterol

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

Time frame
Baseline, 3 months, and 6 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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