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

NCT06542627 | Recruiting DMC

• 1 other identifier: KBSMC 2023-05-010
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PreDiabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  HbA1c assessed by blood test after 2-week use of CGM and dietary education

  8weeks after intervention

Secondary Outcomes (5)

• Fasting blood glucose

  8weeks after intervention

• Lipid profiles

  8weeks after intervention

• Body weight

  8weeks after intervention

• Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)

  8weeks after intervention

• Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).

  8weeks after intervention

Study Arms (1)

CGM arm

EXPERIMENTAL

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

Device: Freestyle Libre

Interventions

Freestyle Libre DEVICE

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

CGM arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• Samsung Electronics: collaborator

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Park

  cydoctor68@gmail.com

  STUDY DIRECTOR

Central Study Contacts

Park

CONTACT

0220011550; cydoctor68@gmail.com

Ko

CONTACT

0220011550; sjaks999@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, MD. PhD

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 7, 2024
• Study Start: May 22, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)