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

Not Applicable

• Conditions: Continuous Glucose Monitoring; Obesity; Prediabetic State
• Interventions: Other: SMBG; Device: RT-CGM

• Registration Number: NCT04099550
• Lead Sponsor: Pusan National University Hospital

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.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-23
• Study Start: 2019-12-06
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-23
• Last Update Posted: 2020-04-24
• Primary Completion: 2020-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMBG with lifestyle intervention	SMBG	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.
RT-CGM with lifestyle intervention	RT-CGM	All participants receive a 12-week lifestyle intervention (diet and exercise). The intervention group was monitored initial 1-week with a RT-CGM.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Jeong Mi Kim; 🇰🇷 Busan, Korea, Republic of