Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes

Study Overview
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Brief Summary
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In Korea, 5 million adults aged 30 years or older have diabetes. The development and expansion of Korea's economy and society, has led to dramatic chances in people's lifestyle and diet habits, and an increase in life expectancy. However, changes in lifestyle and diet habits related to the improvements of socioeconomic status may contribute to an increased diabetes burden in Korea. Therefore, it is important to prevent diabetes. The purpose of this study was to evaluate the effects of real time-continuous glucose measurement (RT-CGM) system compared to only lifestyle modification group on blood glucose, lipid profile and diabetes prevention in prediabetic adults with overweight or obesity.

Detailed Description
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Optimising patient adherence to prescribed lifestyle interventions to achieve improved blood glucose control remains a challenge. Combined use of real-time continuous glucose monitoring (RT-CGM) systems may promote improved glycaemic control. Thirty adult with overweight or obesity and pre-diabetes are randomised to using either RT-CGM or self monitoring of blood glucose (SMBG) for 1 week with lifestyle intervention. After 3 month, outcomes were glycemic control (HbA1c, fasting glucose), weight, and lipid profile assessed pre- and post-intervention.

Official Title
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Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes

Conditions
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Continuous Glucose Monitoring, Prediabetic State, Obesity

Intervention / Treatment
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* Device: RT-CGM
* Other: SMBG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ BMI 23 kg/m2 impaired fasting glucose (fasting glucose 100 to 125 mg/dL) or impaired glucose tolerance (2-h plasma glucose during oral glucose tolerance test (OGTT) 140 - 199 mg/dl) or HbA1c 5.7% to 6.4% Exclusion Criteria: type 1 diabetes or type 2 diabetes or undergoing treatment for diabetes clinical history including malignancy fast history of cardiovascular disease (e.g. myocardial infarction, stroke), surgery, and trauma which may affect blood glucose within last 6 months taking medication (e.g. glucocorticoid, antipsychotics, anticholinergic drug etc.) which affect blood glucose acute infection within last 1 month pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SMBG with lifestyle intervention<br>All participants receive a 12-week lifestyle intervention (diet and exercise). The control group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week. | Other: SMBG<br>* The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.<br>|
| Experimental: RT-CGM with lifestyle intervention<br>All participants receive a 12-week lifestyle intervention (diet and exercise). The intervention group was monitored initial 1-week with a RT-CGM. | Device: RT-CGM<br>* The group was monitored blood glucose initial 1-week with a RT-CGM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C change | All participants receive lifestyle intervention at week 0, week 4, and week 8. The intervention group was monitored initial 1 weeks with a RT-CGM and th control group continued self-monitoring blood glucose (SMBG) at least 2 times a day for 1 week. HbA1c at baseline (week 0) and end of intervention (week 12). | Outcomes were assessed at baseline (week 0) and end of intervention (week 12) | 
| Weight (Kg) change | weight change (Kg) at baseline (week 0) and end of intervention (week 12) | baseline (week 0) and end of intervention (week 12) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | both groups were assessed fasting lipid profile (total cholesterol, triglyceride and HDL-cholesterol) at baseline (week 0) and end of intervention (week 12) | baseline (week 0) and end of intervention (week 12) |