Clinical trial NCT04099550: Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes
Official title: Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Continuous Glucose Monitoring
Prediabetic State
Obesity
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1C change
timeFrame: Outcomes were assessed at baseline (week 0) and end of intervention (week 12)
measure: Weight (Kg) change
timeFrame: baseline (week 0) and end of intervention (week 12)
Secondary outcomes:
measure: lipid profile
timeFrame: baseline (week 0) and end of intervention (week 12)
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Jeong Mi Kim
Study officials:
affiliation: Pusan National University Hospital
name: JEONG MI KIM, M.D
role: PRINCIPAL_INVESTIGATOR
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