Precision Nutrition Counseling in Type 2 Diabetes Patients

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Behavioral: Diet education based on CGMS data; Behavioral: Conventional diet education

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: Sun Joon Moon, MD; Phone Number: 82-2-2072-1471; Email: ipleat.m@gmail.com
    • Contact: Young Min Cho, MD, PHD; Phone Number: 82-2-2072-1965; Email: ymchomd@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: ChunLab

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: February 2, 2020
• First Submitted That Met QC Criteria: February 9, 2020
• First Posted (Actual): February 12, 2020

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: continuous glucose monitor; diet education; Precision nutrition
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H-1911-059-1078

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No