Continuous Glucose Monitoring, Obesity, Prediabetic State
Conditions
Brief summary
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
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.
Interventions
Sponsors
Pusan National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1C change | Outcomes were assessed at baseline (week 0) and end of intervention (week 12) | 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). |
| Weight (Kg) change | baseline (week 0) and end of intervention (week 12) | weight change (Kg) at baseline (week 0) and end of intervention (week 12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | baseline (week 0) and end of intervention (week 12) | both groups were assessed fasting lipid profile (total cholesterol, triglyceride and HDL-cholesterol) at baseline (week 0) and end of intervention (week 12) |
Countries
South Korea
Contacts
Primary ContactJEONG MI KIM, M.D
Outcome results
None listed