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

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ClinicalTrials.gov Identifier: NCT04932928
Recruitment Status : Recruiting
First Posted : June 21, 2021
Last Update Posted : June 21, 2021
Sponsor:
Collaborators:
Inje University
Kangbuk Samsung Hospital
Information provided by (Responsible Party):
Seoul National University Hospital

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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




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



Information from the National Library of Medicine

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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

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): NCT04932928


Contacts
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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
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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
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Principal Investigator: Young Min Cho, MD, PhD Seoul National University Hospital
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT04932928    
Other Study ID Numbers: H-2011-062-117
First Posted: June 21, 2021    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: March 2021
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: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases