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

Not Applicable

Recruiting

• Conditions: Lifestyle Risk Reduction; Diabetes Mellitus, Type 2
• Interventions: Device: FreeStyle Libre; Device: Blood glucose meter

• Registration Number: NCT04932928
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2021-03
• Study Start: 2021-03-23
• Study First Submitted: 2021-06-13
• Study First Submitted QC: 2021-06-13
• Last Update Submitted: 2021-06-13
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21
• Primary Completion: 2022-09-23
• Study Completion: 2023-03-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FreeStyle Libre (CGM) Group	FreeStyle Libre	Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification
Self Monitoring of Blood Glucose (SMBG) Group	Blood glucose meter	Device: Blood glucose meter Education on lifestyle modification

Primary Outcome Measures

Name	Time	Method
Change in HbA1c	Baseline to Month 3	Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of