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

Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; PreDiabetes
• Intervention / Treatment: Device: Freestyle Libre

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Park; Phone Number: 0220011550; Email: cydoctor68@gmail.com
• Study Contact Backup: Name: Ko; Phone Number: 0220011550; Email: sjaks999@gmail.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
    • Contact: Cheol-Young Park, MD, PhD; Phone Number: +82220011550; Email: cydoctor68@gmail.com
    • Contact: Jihee Ko, MD; Phone Number: +82220011550; Email: sjaks999@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM arm; Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.	Device: Freestyle Libre; Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	HbA1c assessed by blood test after 2-week use of CGM and dietary education	8weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting blood glucose	Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education	8weeks after intervention
Lipid profiles	Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education	8weeks after intervention
Body weight	Body weight assessed by blood test after 2-week use of CGM and dietary education	8weeks after intervention
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)	Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of three parts.; total satisfaction (minimum 0, maximum 36, higher scores mean a better outcome.); perceived hyperglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.); perceived hypoglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)	8weeks after intervention
Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).	Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of five parts.; diet (values: minimum 0, maximum 28, higher scores mean a better outcome.); exercise (minimum 0, maximum 14, higher scores mean a better outcome.); blood sugar check-up (values: minimum 0, maximum 14, higher scores mean a better outcome.); foot care (minimum 0, maximum 14, higher scores mean a better outcome.); smoking (minimum 0, maximum 1, higher scores mean a worse outcome.)	8weeks after intervention

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: Samsung Electronics
• Investigators: Study Director: Park, cydoctor68@gmail.com

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 1, 2024
• First Submitted That Met QC Criteria: August 6, 2024
• First Posted (Actual): August 7, 2024

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: August 6, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: KBSMC 2023-05-010

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