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NCT Number: NCT07794384

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Self-management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Diabetes management self-efficacy

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

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

  2. Diabetes self-management obstacles

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

    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.

Secondary outcomes

  1. HbA1c

    Time frame: Baseline, 3 months, and 6 months

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

  2. Fasting plasma glucose

    Time frame: Baseline, 3months, and 6months

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

  3. Triglycerides

    Time frame: Baseline, 3months, and 6 months

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

  4. Total cholesterol

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

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

  5. LDL

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

    Serum low-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).

  6. HDL

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

    Serum high-density lipoprotein cholesterol will be measured using laboratory blood tests and reported in milligrams per deciliter (mg/dL).

Sponsors and collaborators

Lead sponsor

Fu Jen Catholic University Hospital

Other

Registry information

Official study title

Construction and Evaluation of a Self-management APP for Effectiveness in Self-Management, Self-Efficacy, and Metabolic Indicators of Patients With Type 2 Diabetes.

Acronym: Application

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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