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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKangbuk Samsung Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects over the age of 19

Patients with type 2 diabetes

Fasting blood glucose ≥ 126 mg/dL or

HbA1c ≥ 6.5% or

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Freestyle Libre

    Device

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

Treatment groups

420 Participants
are divided into 1 treatment group
Group A: CGM armExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kangbuk Samsung Hospital

Lead sponsor

Samsung Electronics

Collaborator