A Multicenter, Randomized, Open, Parallel Group Clinical Study to Evaluate the Efficacy of diabetes Management System Using Mobile application on diabetic control in adult patients with type2 Diabetes mellitus
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0004128
- Brief Summary
A system that combines technology and web-based coaching can help treat chronic conditions such as diabetes. However, the effectiveness of apps in mobile health (mHealth) interventions is inconclusive and unclear due to heterogeneous interventions and varying follow-up durations. In addition, randomized controlled trial data are limited, and long-term follow-up is lacking, especially for apps integrated into electronic medical records. So, we aimed to assess the effect of an electronic medical record–integrated mobile app for personalized diabetes self-care, focusing on the self-monitoring of blood glucose and lifestyle modifications, on glycemic control in patients with type 2 diabetes mellitus. In a 26-week, 3-arm, randomized, controlled, open-label, parallel group trial, patients with type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) level of =7.5% were recruited. The mHealth intervention consisted of self-monitoring of blood glucose with the automatic transfer of glucose, diet, and physical activity counseling data (iCareD system). Participants were randomly assigned to the following three groups: usual care (UC), mobile diabetes self-care (MC), and MC with personalized, bidirectional feedback from physicians (MPC). The primary outcome was the change in HbA1c levels at 26 weeks. In addition, diabetes-related self-efficacy, self-care activities, and satisfaction with the iCareD system were assessed after the intervention. A total of 269 participants were enrolled, and 234 patients (86.9%) remained in the study at 26 weeks. At 12 weeks after the intervention, the mean decline in HbA1c levels was significantly different among the 3 groups (UC vs MC vs MPC: -0.49% vs -0.86% vs -1.04%; P=.02). The HbA1c level decreased in all groups; however, it did not differ among groups after 26 weeks. In a subgroup analysis, HbA1c levels showed a statistically significant decrease after the intervention in the MPC group compared with the change in the UC or MC group, especially in patients aged <65 years (P=.02), patients with a diabetes duration of =10 years (P=.02), patients with a BMI of =25.0 kg/m2 (P=.004), patients with a C-peptide level of =0.6 ng/mL (P=.008), and satisfied with the iCareD system. The mHealth intervention for diabetes self-care showed short-term efficacy in glycemic control, and the effect decreased over time. The participants were comfortable with using the iCareD system and exhibited high adherence.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 269
To participate in this clinical trial, all of the following criteria must be met:
1) Type 2 diabetes patients who need to measure their own blood sugar and are trained in diabetes self-management
2) Men and women aged 19 years or older and under 75 years of age
3) HbA1c 7.5% or more at baseline
4) BMI 18.5 kg/m2 or higher
5) Those who can use a smartphone
6) Those who agree to participate in this clinical trial and who agree in writing to the consent
Any of the following subjects should be excluded from this clinical trial:
1) Patients on treatment with insulin pump
2) Patients with severe renal diseases: eGFR <30ml/min
3) Patients with heart failure corresponds to New Your Heart Association III-IV
4) Persons who have been diagnosed with malignant tumors within the last five years and have not been treated
5) Recipients of organ transplants or persons requiring long-term immunosuppression
6) Pregnant or breastfeeding
7) Those who plan to conceive during a clinical trial or who do not agree to appropriate contraception
8) Persons who participated in other clinical trials within 90 days of screening (excluding observational studies)
9) Persons are considered unfit to participate in a this clinical trial when judging by the investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in HbA1c over 26 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in HbA1c over 52 weeks;Change from baseline in fasting plasma glucose over 26, 52 weeks;Change from baseline in lifestyle (activity, eating records);Change from baseline in cardiovascular disease risk factors (body weight, blood pressure, lipid profile);Change from baseline in quality of life;Program satisfaction and compliance;An acummulated unexpected utilization rate by medical institutions due to the development of hypoglycemia or hyperglycemia;An effect on development of hypoglycemia and hyperglycemia;Change from baseline in Homeostasis Model Assessment (HOMA)-insulin resistance,Homeostasis Model Assessment -beta over 26, 52 weeks