NCT04266171

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 2, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 12, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 12, 2020

Status Verified

January 1, 2020

Enrollment Period

2 years

First QC Date

February 2, 2020

Last Update Submit

February 9, 2020

Conditions

Type 2 Diabetes

Keywords

continuous glucose monitordiet educationPrecision nutrition

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c from baseline

    0 week, 12 weeks

Secondary Outcomes (11)

  • 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

  • +6 more secondary outcomes

Study Arms (2)

CGMS Diet Education

EXPERIMENTAL
Behavioral: Diet education based on CGMS data

Conventional Diet Education

ACTIVE COMPARATOR
Behavioral: Conventional diet education

Interventions

Diet education based on CGMS dataBEHAVIORAL

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.

CGMS Diet Education
Conventional diet educationBEHAVIORAL

Control group will receive conventional diabetes diet education without CGMS data.

Conventional Diet Education

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2020

First Posted

February 12, 2020

Study Start

January 16, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 12, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)