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

April 23, 2020 updated by: JEONG MI KIM, Pusan National University Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SMBG with lifestyle intervention
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
The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
Experimental: RT-CGM with lifestyle intervention
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
The group was monitored blood glucose initial 1-week with a RT-CGM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C change
Time Frame: 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).
Outcomes were assessed at baseline (week 0) and end of intervention (week 12)
Weight (Kg) change
Time Frame: baseline (week 0) and end of intervention (week 12)
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
Time Frame: 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)
baseline (week 0) and end of intervention (week 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: JEONG MI KIM, M.D, Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 6, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 20, 2019

First Posted (Actual)

September 23, 2019

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNUHEnMJMK1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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