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

Primary Purpose

Continuous Glucose Monitoring, Prediabetic State, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
RT-CGM
SMBG
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Continuous Glucose Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Jeong Mi KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SMBG with lifestyle intervention

RT-CGM with lifestyle intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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).
Weight (Kg) change
weight change (Kg) at baseline (week 0) and end of intervention (week 12)

Secondary Outcome Measures

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)

Full Information

First Posted
September 10, 2019
Last Updated
April 23, 2020
Sponsor
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04099550
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Continuous Glucose Monitoring, Prediabetic State, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMBG with lifestyle intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RT-CGM with lifestyle intervention
Arm Type
Experimental
Arm Description
All participants receive a 12-week lifestyle intervention (diet and exercise). The intervention group was monitored initial 1-week with a RT-CGM.
Intervention Type
Device
Intervention Name(s)
RT-CGM
Intervention Description
The group was monitored blood glucose initial 1-week with a RT-CGM.
Intervention Type
Other
Intervention Name(s)
SMBG
Intervention Description
The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
Primary Outcome Measure Information:
Title
HbA1C change
Description
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).
Time Frame
Outcomes were assessed at baseline (week 0) and end of intervention (week 12)
Title
Weight (Kg) change
Description
weight change (Kg) at baseline (week 0) and end of intervention (week 12)
Time Frame
baseline (week 0) and end of intervention (week 12)
Secondary Outcome Measure Information:
Title
lipid profile
Description
both groups were assessed fasting lipid profile (total cholesterol, triglyceride and HDL-cholesterol) at baseline (week 0) and end of intervention (week 12)
Time Frame
baseline (week 0) and end of intervention (week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JEONG MI KIM, M.D
Phone
82-10-9431-3733
Email
marse007@hanmail.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
JEONG MI KIM, M.D
Organizational Affiliation
Pusan National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jeong Mi Kim
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeong M Kim, MD
Phone
82-10-9431-3733
Email
marse007@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes

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