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

K

Kangbuk Samsung Hospital

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2
PreDiabetes

Treatments

Device: Freestyle Libre

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06542627
KBSMC 2023-05-010

Details and patient eligibility

About

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.

Enrollment

420 estimated patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

420 participants in 1 patient group

CGM arm
Experimental group
Description:
Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
Treatment:
Device: Freestyle Libre

Trial contacts and locations

1

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Central trial contact

Park; Ko

Data sourced from clinicaltrials.gov

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