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NCT Number: NCT06542627

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

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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Freestyle Libre

Device

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

Primary outcomes

  1. HbA1c

    Time frame: 8weeks after intervention

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

Secondary outcomes

  1. Fasting blood glucose

    Time frame: 8weeks after intervention

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

  2. Lipid profiles

    Time frame: 8weeks after intervention

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

  3. Body weight

    Time frame: 8weeks after intervention

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

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

    Time frame: 8weeks after intervention

    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.)

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

    Time frame: 8weeks after intervention

    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.)

Study contacts

Contact information is provided by the study sponsor or research team.

Ko

CONTACT

[email protected]

0220011550

Park

CONTACT

[email protected]

0220011550

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 7, 2024
Registry last updated
Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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