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出境医 / 临床实验 / Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients (PDF)

Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients (PDF)

Study Description
Brief Summary:

We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.

Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Lifestyle Risk Reduction Device: FreeStyle Libre Device: Blood glucose meter Not Applicable

Detailed Description:

Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study

This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.

It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.

Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Actual Study Start Date : March 23, 2021
Estimated Primary Completion Date : September 23, 2022
Estimated Study Completion Date : March 23, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: FreeStyle Libre (CGM) Group
Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification
 Device: FreeStyle Libre
Flash glucose monitoring + Education on lifestyle modification
Other Name: Education on lifestyle modification
Active Comparator: Self Monitoring of Blood Glucose (SMBG) Group
Device: Blood glucose meter Education on lifestyle modification
 Device: Blood glucose meter
Self monitoring of blood glucose + Education on lifestyle modification
Other Name: Education on lifestyle modification
Outcome Measures
Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3


Secondary Outcome Measures :
  1. Change in mean fasting glucose [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3

  2. Change in body weight [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3

  3. Change in blood pressure [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3

  4. Change in waist circumference [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3

  5. Change in lipid level [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in lipid level (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) from baseline to Month 3

  6. Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3


Other Outcome Measures:
  1. Change in CGM time in target range [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group

  2. Change in CGM time-hyperglycemic [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in time above target range, defined as >250 mg/dL from baseline to Month 3 in the CGM group

  3. Change in CGM time-hypoglycemic [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in time below target range, defined as <70 mg/dL (level 1) and < 54 (level 2) from baseline to Month 3 in the CGM group

  4. Change in CGM glucose variability [ Time Frame: Baseline to Month 3 ]
    Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 19-80
  • Diagnosed with type 2 diabetes mellitus (DM)
  • Uncontrolled type 2 DM: HbA1c 7.0-10.0%
  • Signed informed consent

Exclusion Criteria:

  • Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
  • Use of prandial insulin
  • Change in diabetes medication in the preceding 3 months
  • Pregnant/lactating women
  • Addiction to drugs and alcohol
  • Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
  • Severe liver disease
  • End-stage renal disease (i.e. on dialysis)
  • Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
  • Conditions that impact the stability of HbA1c measurement
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Hun Jee Choe, MD 82-2-2072-1965 hunjeechoe@snu.ac.kr
Contact: Young Min Cho, MD, PhD 82-2-2072-1965 ymchomd@snu.ac.kr

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Young Min Cho, MD, PHD    82-2-2072-1965    ymchomd@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Hospital
Inje University
Kangbuk Samsung Hospital
Investigators
Layout table for investigator information
Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
Tracking Information
First Submitted Date  ICMJE June 13, 2021
First Posted Date  ICMJE June 21, 2021
Last Update Posted Date June 21, 2021
Actual Study Start Date  ICMJE March 23, 2021
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2021) 		Change in HbA1c [ Time Frame: Baseline to Month 3 ]
Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2021)
  • Change in mean fasting glucose [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3
  • Change in body weight [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3
  • Change in blood pressure [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3
  • Change in waist circumference [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3
  • Change in lipid level [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in lipid level (total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) from baseline to Month 3
  • Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score [ Time Frame: Baseline to Month 3 ]
    Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 13, 2021)
  • Change in CGM time in target range [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group
  • Change in CGM time-hyperglycemic [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in time above target range, defined as >250 mg/dL from baseline to Month 3 in the CGM group
  • Change in CGM time-hypoglycemic [ Time Frame: Baseline to Month 3 ]
    Change in CGM time in time below target range, defined as <70 mg/dL (level 1) and < 54 (level 2) from baseline to Month 3 in the CGM group
  • Change in CGM glucose variability [ Time Frame: Baseline to Month 3 ]
    Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Official Title  ICMJE Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Brief Summary

We aim to provide medical nutritional therapy to patients with type 2 diabetes who are on oral hypoglycemic agents or on basal insulin only and monitor the glycemic response with flash glucose monitoring or self-monitoring of blood glucose.

Specifically, this is a randomized, open-label, controlled study where half of the study participants will have FreeStyle Libre device on for 12 weeks and compare the change in glycated hemoglobin (HbA1c) value with the patients in the control group.
Detailed Description

Subjects: 126 patients with type 2 diabetes mellitus Scheme: Multi-center, Randomized, open-label, controlled study

This study is referred to as the "Patient-Driven lifestyle modification using FreeStyle Libre in type 2 diabetes patients", also known as the PDF study.

It will assess potential benefits of using Continuous Glucose Monitoring (CGM) versus Self Monitoring of Blood Glucose (SMBG) when combined with personalized education on lifestyle modification in people with type 2 diabetes. Specifically, we will investigate patients who have an elevated HbA1c between 7.0 - 10.0% who are not using prandial insulin.

Potential participants will be screened from routine outpatient clinic visits, will be randomized to either the CGM or SMBG group in a 1:1 ratio. Participants from both groups will receive education on lifestyle modification and will be reminded every 4 weeks with structured phone visits. Study will be completed at the visit on 12 weeks of follow up with the same laboratory examinations (including HbA1c) and survey from the baseline.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Lifestyle Risk Reduction
Intervention  ICMJE
  • Device: FreeStyle Libre
    Flash glucose monitoring + Education on lifestyle modification
    Other Name: Education on lifestyle modification
  • Device: Blood glucose meter
    Self monitoring of blood glucose + Education on lifestyle modification
    Other Name: Education on lifestyle modification
Study Arms  ICMJE
  • Experimental: FreeStyle Libre (CGM) Group
    Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification
    Intervention: Device: FreeStyle Libre
  • Active Comparator: Self Monitoring of Blood Glucose (SMBG) Group
    Device: Blood glucose meter Education on lifestyle modification
    Intervention: Device: Blood glucose meter
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 13, 2021) 		126
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 23, 2023
Estimated Primary Completion Date September 23, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 19-80
  • Diagnosed with type 2 diabetes mellitus (DM)
  • Uncontrolled type 2 DM: HbA1c 7.0-10.0%
  • Signed informed consent

Exclusion Criteria:

  • Diagnosed with other types of diabetes mellitus (i.e. Type 1 DM)
  • Use of prandial insulin
  • Change in diabetes medication in the preceding 3 months
  • Pregnant/lactating women
  • Addiction to drugs and alcohol
  • Use of medications that result in drug-induced hyperglycemia (i.e. steroid)
  • Severe liver disease
  • End-stage renal disease (i.e. on dialysis)
  • Unable to wear CGM devices due to dermatologic side effects (i.e. severe burn, inflammation, active skin infection, severe skin reactions, hypertrichosis, etc.)
  • Conditions that impact the stability of HbA1c measurement
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hun Jee Choe, MD 82-2-2072-1965 hunjeechoe@snu.ac.kr
Contact: Young Min Cho, MD, PhD 82-2-2072-1965 ymchomd@snu.ac.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04932928
Other Study ID Numbers  ICMJE H-2011-062-117
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE
  • Inje University
  • Kangbuk Samsung Hospital
Investigators  ICMJE
Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
PRS Account Seoul National University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP