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

Study Overview
=================
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.

Official Title
-----------------
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients

Conditions
-----------------
Diabetes Mellitus, Type 2, Lifestyle Risk Reduction

Intervention / Treatment
-----------------
* Device: FreeStyle Libre
* Device: Blood glucose meter


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FreeStyle Libre (CGM) Group<br>Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification | Device: FreeStyle Libre<br>* Flash glucose monitoring + Education on lifestyle modification<br>* Other names: Education on lifestyle modification;|
| Active Comparator: Self Monitoring of Blood Glucose (SMBG) Group<br>Device: Blood glucose meter Education on lifestyle modification | Device: Blood glucose meter<br>* Self monitoring of blood glucose + Education on lifestyle modification<br>* 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 |