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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04099550
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
JEONG MI KIM, 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.


Condition or disease Intervention/treatment Phase
Continuous Glucose Monitoring Prediabetic State Obesity Device: RT-CGM Other: SMBG Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: participants were randomised to undertake a 12-week lifestyle intervention with either RT-CGM or SMBG
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Real-time Continuous Glucose Monitoring System in Overweight or Obese Adults With Prediabetes
Actual Study Start Date : December 6, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

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.




Primary Outcome Measures :
  1. 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).


  2. 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)


Secondary Outcome Measures :
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04099550


Contacts
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Contact: JEONG MI KIM, M.D 82-10-9431-3733 marse007@hanmail.net

Locations
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Korea, Republic of
Jeong Mi Kim Recruiting
Busan, Korea, Republic of, 49241
Contact: Jeong M Kim, MD    82-10-9431-3733    marse007@hanmail.net   
Sponsors and Collaborators
Pusan National University Hospital
Investigators
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Principal Investigator: JEONG MI KIM, M.D Pusan National University Hospital
Additional Information:
Publications:

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Responsible Party: JEONG MI KIM, Assistant Professor, Pusan National University Hospital
ClinicalTrials.gov Identifier: NCT04099550    
Other Study ID Numbers: PNUHEnMJMK1
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prediabetic State
Overweight
Body Weight
Signs and Symptoms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases