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RecruitingNCT06542627Updated Aug 7, 2024

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

An interventional study of Freestyle Libre in PreDiabetes and Diabetes Mellitus, Type 2, sponsored by Kangbuk Samsung Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Kangbuk Samsung Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study 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.

02

Conditions studied

03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
420 participants (estimated)

Study arms

  • Experimental
    CGM arm

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

    Device: Freestyle Libre

Interventions

  • DeviceFreestyle Libre

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

05

What researchers measure

Primary outcomes

  1. HbA1c

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

    Time frame: 8weeks after intervention

Secondary outcomes

  1. Fasting blood glucose

    Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education

    Time frame: 8weeks after intervention

  2. Lipid profiles

    Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education

    Time frame: 8weeks after intervention

  3. Body weight

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

    Time frame: 8weeks after intervention

  4. 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.)

    Time frame: 8weeks after intervention

  5. 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.)

    Time frame: 8weeks after intervention

06

Study locations

1 of 1 sites recruiting
  • Kangbuk Samsung Hospital
    Seoul, 03181, Korea, Republic of
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06542627
Lead sponsor
Kangbuk Samsung Hospital
Collaborators
Samsung Electronics
Responsible party
Cheol-Young Park (Professor, MD. PhD, Kangbuk Samsung Hospital) — Principal investigator
First posted
Aug 7, 2024
Start date
May 22, 2023
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Aug 7, 2024

Study contacts

Park
Contact
cydoctor68@gmail.com
0220011550
Ko
Contact
sjaks999@gmail.com
0220011550
Park
study director · cydoctor68@gmail.com

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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