Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort Study

NCT ID: NCT06542627

Last Updated: 2024-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

420 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-22

Study Completion Date

2025-12-31

Brief Summary

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This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.

Detailed Description

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Conditions

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PreDiabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CGM arm

Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.

Group Type EXPERIMENTAL

Freestyle Libre

Intervention Type DEVICE

Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.

Interventions

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Freestyle Libre

Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects over the age of 19
* Patients with type 2 diabetes

* Fasting blood glucose ≥ 126 mg/dL or
* HbA1c ≥ 6.5% or
* Type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle Modifications
* Patients with prediabetes

* Fasting blood glucose 100-125 mg/dL
* HbA1c 5.7-6.4%
* Willing to participate in the study

Exclusion Criteria

* Subjects less than 19 years old
* Patients with type 1 diabetes
* Pregnant at the time of screening or planning to become pregnant during the study
* Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
* Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
* Severe liver disease (e.g., cancer, liver cirrhosis, hepatitis B, hepatitis C)
* Diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections
* Planning to be admitted to a hospital within 2 months
* Unable to participate in the mobile intervention study as determined by the investigator
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Samsung Electronics

INDUSTRY

Sponsor Role collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheol-Young Park

Professor, MD. PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Park

Role: STUDY_DIRECTOR

[email protected]

Locations

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Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Park

Role: CONTACT

0220011550

Ko

Role: CONTACT

0220011550

Facility Contacts

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Cheol-Young Park, MD, PhD

Role: primary

+82220011550

Jihee Ko, MD

Role: backup

+82220011550

Other Identifiers

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KBSMC 2023-05-010

Identifier Type: -

Identifier Source: org_study_id

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