Precision Nutrition Counseling in Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Development of Precision Nutrition Counseling in Type 2 Diabetes Patients: Using Continuous Glucose Monitoring System

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Diet education based on CGMS data
* Behavioral: Conventional diet education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes patients (Fasting blood glucose ≥ 126 mg/dl or HbA1c ≥ 6.5% or Subjects who were previously diagnosed with type 2 diabetes and who have been treated with lifestyle modification only, oral anti-diabetic drugs or basal insulin) HbA1c 6.5% 10% Body weight change less than 5% in 3 month Subjects who agreed to the study protocol Exclusion Criteria: Type 1 diabetes patients Subjects using insulin other than basal insulin Subjects who have newly started or have changed anti diabetic drugs within 3 months Subjects who have been received diabetes diet education within 6 months Females who are pregnant or doing breast feeding Subjects with alcohol addiction or drug abuse Subjects who are using drugs that can influence blood glucose levels (e.g. steroid) Subjects who are currently using acetaminophen or who should use acetaminophen during CGMS attach period Subjects who have skin problems on CGMS sensor insertion site (e.g. burn, excessive body hair, inflammation, rash, tattoo) Subjects who have newly started, changed, or stoped probiotics or prebiotics within 2 weeks Subjects who have used antibiotics (oral or intravenous) within 2 weeks In addition, if it falls under the exclusion criteria according to researchers discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGMS Diet Education<br> | Behavioral: Diet education based on CGMS data<br>* 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.<br>|
| Active Comparator: Conventional Diet Education<br> | Behavioral: Conventional diet education<br>* Control group will receive conventional diabetes diet education without CGMS data.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | 0 week, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet education, continuous glucose monitor, Precision nutrition