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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Lifestyle Risk Reduction
• Intervention / Treatment: Device: FreeStyle Libre; Device: Blood glucose meter

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: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Young Min Cho, MD, PHD; Phone Number: 82-2-2072-1965; Email: ymchomd@snu.ac.kr
• Study Contact Backup: Name: Hun Jee Choe, MD; Phone Number: 82-2-2072-1965; Email: hunjeechoe@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Recruiting
    • Seoul National University Hospital
    • Contact: Young Min Cho, MD, PHD; Phone Number: 82-2-2072-1965; Email: ymchomd@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Education on lifestyle modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c	Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3	Baseline to Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mean fasting glucose	Between group differences (CGM and SMBG) for the change in fasting glucose from baseline to Month 3	Baseline to Month 3
Change in body weight	Between group differences (CGM and SMBG) for the change in body weight from baseline to Month 3	Baseline to Month 3
Change in blood pressure	Between group differences (CGM and SMBG) for the change in blood pressure from baseline to Month 3	Baseline to Month 3
Change in waist circumference	Between group differences (CGM and SMBG) for the change in waist circumference from baseline to Month 3	Baseline to Month 3
Change in lipid level	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	Baseline to Month 3
Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score	Between group differences (CGM and SMBG) for the change in survey score from baseline to Month 3	Baseline to Month 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CGM time in target range	Change in CGM time in target range 70-180 mg/dL from baseline to Month 3 in the CGM group	Baseline to Month 3
Change in CGM time-hyperglycemic	Change in CGM time in time above target range, defined as >250 mg/dL from baseline to Month 3 in the CGM group	Baseline to Month 3
Change in CGM time-hypoglycemic	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	Baseline to Month 3
Change in CGM glucose variability	Change in CGM glucose variability measured by the coefficient of variation from baseline to Month 3 in the CGM group	Baseline to Month 3

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Inje University; Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• Choe HJ, Rhee EJ, Won JC, Park KS, Lee WY, Cho YM. Effects of Patient-Driven Lifestyle Modification Using Intermittently Scanned Continuous Glucose Monitoring in Patients With Type 2 Diabetes: Results From the Randomized Open-label PDF Study. Diabetes Care. 2022 Oct 1;45(10):2224-2230. doi: 10.2337/dc22-0764.

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Anticipated): September 23, 2022
• Study Completion (Anticipated): March 23, 2023

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 13, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 13, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: H-2011-062-117

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: Yes
• product manufactured in and exported from the U.S.: No