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临床试验/KCT0002554
KCT0002554已完成未知

Evaluation of complex chronic disease monitoring & management system on the glucose control and patients’ satisfaction in the type 2 diabetes with primary clinic outpatient care

The Catholic University of Korea, Seoul St. Mary's Hospital0 个研究点目标入组 250 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
入组人数
250

研究概览

简要总结

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.

研究设计

研究类型
Interventional Study

入排标准

年龄范围
18(Year) 至 o Limit(—)
性别
All

入选标准

  • 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%.

排除标准

  • 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.

研究者

发起方
The Catholic University of Korea, Seoul St. Mary&#39;s Hospital

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