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Clinical study to evaluate the efficacy of diabetes self-care system using mobile application on diabetic control

A 12-week, randomized, open, parallel group clinical study to evaluate the efficacy of diabetes self-care system using mobile application on diabetic control in adult patients with type 2 diabetes mellitus in real clinical setting

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0007749
Enrollment
178
Registered
2022-09-29
Start date
2022-09-19
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : In both control group and intervention group, basic educational materials are provided, and standard treatment is performed in accordance with the guidelines of the Korean Diabetes Associatio

Sponsors

The Catholic University of Korea, St. Vincent's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All of the following criteria must be satisfied to participate in this clinical trial. 1) Subjects with type 2 diabetes who require self-monitoring of blood glucose 2) Men and women between the ages of 19 and 75 3) Baseline HbA1c = 7.5% 4) BMI = 18.5 kg/m2 5) Subjects who can use a smartphone 6) Subjects who have agreed to participate in this clinical trial and have given their written consent

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1) Subjects with an insulin pump 2) Subjects with chronic kidney disease with eGFR <30 ml/min 3) Subjects with New Your Heart Association (NYHA) classification III-IV 4) Subjects with a malignant tumor within the last 5 years and have not completed treatment 5) Organ transplant recipients or those who need to take long-term immunosuppressants 6) Subjects with difficulty in movement or activity due to spinal diseases (disc herniation, spinal stenosis), other joint diseases, and major surgery at the time of screening 7) Subjects who plan to undergo surgery that is considered to have restrictions on post-operative activities during the clinical trial period 8) Pregnant or lactating women 9) Subjects who are planning to become pregnant during the clinical trial period or who do not agree to use appropriate contraception 10) Subjects who participated other clinical trials within 90 days of screening (excluding observational studies) 11) Subjects who are judged to be inappropriate to participate in clinical trials at the time of the investigator's judgment

Design outcomes

Primary

MeasureTime frame
Changes in HbA1c level from baseline to week 12

Secondary

MeasureTime frame
Changes in fasting glucose level from baseline to week 12;Percentages of subjects who meet HbA1c <7.0% at week 12;Percentages of subjects who meet HbA1c <6.5% at week 12;Hypoglycemia-related hospital visits from baseline to week 12;Hyperglycemia-related hospital visits from baseline to week 12;Changes in lipidil profile (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol) from baseline to week 12;Changes in self-care management (physical activity, eating behavior, sleep pattern) from baseline to week 12

Countries

Korea, Republic of

Contacts

Public ContactKyuho Kim

The Catholic University of Korea, St. Vincent's Hospital

penguinkkhneo@gmail.com+82-31-881-8938

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026