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Clinical Trials/KCT0002554
KCT0002554
Completed
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 sites250 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Endocrine, nutritional and metabolic disease
Sponsor
The Catholic University of Korea, Seoul St. Mary's Hospital
Enrollment
250
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional Study
Sex
All

Investigators

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

Eligibility Criteria

Inclusion Criteria

  • 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%.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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