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Not yet recruitingNCT07794384ApplicationUpdated Aug 31, 2026

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

An interventional study of Researcher-Designed Diabetes Self-Management Application in Type 2 Diabetes Mellitus (T2DM) and Self-management, sponsored by Fu Jen Catholic University Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Fu Jen Catholic University Hospital · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Type 2 Diabetes Mellitus (T2DM)
  • Self-management

Keywords

  • Diabetes self-management
  • Diabetes Obstacles
  • Self-efficacy
  • Metabolic indicators
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    Basic self-management mobile application use.

    Participants in the control group will receive routine diabetes care and use the basic functions of the diabetes self-management mobile application. The basic app functions include self-recording of blood glucose, medication, diet, physical activity, and related health information. Participants in this group will not receive additional video-based health education or multidisciplinary team care through the application.

  • Experimental
    Enhanced diabetes self-management mobile application use.

    Participants in the intervention group will receive routine diabetes care and access to an enhanced diabetes self-management mobile application, which includes basic self-management recording functions, video-based health education, and multidisciplinary team care to support diabetes self-management.

    Behavioral: Researcher-Designed Diabetes Self-Management Application

Interventions

  • BehavioralResearcher-Designed Diabetes Self-Management Application

    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.

05

What researchers measure

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.

  5. LDL

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

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

  6. HDL

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

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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT07794384
Lead sponsor
Fu Jen Catholic University Hospital
Responsible party
SZU-YI WANG (Principal Investigator, Fu Jen Catholic University Hospital) — Principal investigator
First posted
Aug 31, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Aug 31, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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