Clinical study to evaluate the efficacy of diabetes self-care system using mobile application on diabetic control
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007749
- Brief Summary
HbA1c levels were more markedly decreased in the MMS group (8.4%±0.7% to 8.0%±1.1%) than in the control group (8.5%±0.8% to 8.4%±0.8%), resulting in a significant between-group difference (P=0.027). No differences were observed in changes in fasting glucose levels, lipid profiles, and the number of participants who experienced hypoglycemia, or in changes in lifestyle behavior between groups. However, the self-monitoring of blood glucose frequency was significantly increased in the MMS group compared to the control group (P=0.003). In addition, sleep duration was increased in the MMS group, but was not changed in the control group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 110
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in HbA1c level from baseline to week 12
- Secondary Outcome Measures
Name Time Method 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