Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ChunLab | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of this study is to evaluate the effect of precision nutrition education using continuous glucose monitoring system (CGMS) in longterm glycemic control in patients with type 2 diabetes mellitus. Glucose levels in subjects who received diet education using CGMS will be compared to those in subjects who received conventional diet education.
Fifty subjects with type 2 diabetes will be recruited. Every subject will be randomized in two groups, which are CGMS education group and conventional education group. The study will be conducted for 12 weeks for each participants. Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. Primary outcome is change of HbA1c from baseline for 12 weeks, and secondary outcomes are changes of fasting blood glucose level, body weight, waist circumference, blood lipid level, homeostatic model assessment of insulin resistance (HOMA-IR) , c-peptide, microbiome, 7-point self monitoring of blood glucose (SMBG), and compliance/satisfaction questionnaire from baseline for 12 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGMS Diet Education | Experimental |
| |
| Conventional Diet Education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet education based on CGMS data | Behavioral | Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline | 0 week, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fasting blood glucose level from baseline | 0 week, 12 weeks | |
| Change in body weight from baseline | 0 week, 12 weeks | |
| Change in waist circumference from baseline |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Conventional diet education | Behavioral | Control group will receive conventional diabetes diet education without CGMS data. |
|
| 0 week, 12 weeks |
| Change in blood Triglyceride level from baseline | 0 week, 12 weeks |
| Change in blood High-density lipoprotein level from baseline | 0 week, 12 weeks |
| Change in blood Low-density lipoprotein level from baseline | 0 week, 12 weeks |
| Change in HOMA-IR from baseline | 0 week, 12 weeks |
| Change in c-peptide from baseline | 0 week, 12 weeks |
| Change in microbiome profile from baseline | Change in the diversity index of the gut microbiota, change in the compositions of the gut microbiota | 0 week, 12 weeks |
| Change in 7-point SMBG from baseline | 0 week, 12 weeks |
| Compliance/Satisfaction Questionnaire | Change in dietary habits, self-efficacy of diet management , and satisfaction with the education | 0 week, 12 weeks |
| D004700 | Endocrine System Diseases |