Effect of a smartphone-based glucose monitoring system in multiple private clinic settings
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0002554
- Lead Sponsor
- The Catholic University of Korea, Seoul St. Mary's Hospital
- Brief Summary
At the three-month follow-up, the participants in the intervention group showed increased reduction in HbA1c (-0.63 ± 0.82 vs. -0.27 ± 0.71 %, p < 0.0001) and fasting plasma glucose (-18.86 ± 63.35 vs. -2.33 ± 53.67 mg/dL, p = 0.0125) levels compared to those in the control group. At 3 months of baseline, the HbA1c 7% reach rate was 6.67% (10 patients) in the intervention group and 6.19% (6 patients) in the control group and there was no statistically significant difference between the two groups (p-value = 0.8807). The HbA1c 6.5% reach rate was 32.67% (49 patients) in the test group and 23.71% (23 patients) in the control group. There was no statistically significant difference between the two groups (p-value = 0.1304). A significantly increased reduction in diastolic blood pressure (BP), a tendency for reduced systolic BP, and elevated high-density lipoprotein cholesterol level were also observed in the intervention group. In the subgroup analysis, the effect on glycemic control was more significant among patients with good compliance to self-monitoring blood glucose, younger age (under 60 years), and poor baseline control (HbA1c = 8%). In addition, increased treatment satisfaction and medication adherence were observed in the intervention group. 18 patients (12.00%) in the test group and 8 patients (8.25%) in the control group showed 26 cases of adverse events. All adverse events were not causally related to the test device. Cerebral infarction-related deaths occurred in one (1) subject in the control group with significant adverse events, but the causal relationship with the testing device was not clearly related and there were no drug-related actions taken.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 250
The eligible participants were over 18 years of age and had type 2 diabetes for more than one year. Their baseline glycated hemoglobin (HbA1c) levels were between 7.0 and 10.0%.
Participants with any significant medical diseases were excluded. Those with creatinine levels higher than 1.5 or 1.4 mg/dL for men or women, respectively, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels more than 2.5 times the upper normal limit, were also excluded. We excluded participants who had not been taking stable diabetes medications for the three months before enrollment. Insulin pump users were not included in this study. Participants of other clinical trials or plans were also excluded.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c
- Secondary Outcome Measures
Name Time Method fasting glucose ;systolic blood pressure ;diastolic blood pressure ;body weight;waist circumference;Total cholesterol;Triglyceride;HDL-cholesterol;LDL-cholesterol;MMS: Modified Morisky Scale;PACIC: Patient Assessment of Chronic Illness Care;DTSQs and DTSQc, Diabetes Treatment Satisfaction Questionnaire s tatus and change version;Satisfaction after smartphone-based monitoring service ;adverse events