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

Seoul National University

Status: Enrolling

Conditions: Lifestyle Risk Reduction; Diabetes Mellitus, Type 2

Treatments: Device: Blood glucose meter; Device: FreeStyle Libre

Study type: Interventional

Funder types: Other

Identifiers

NCT04932928

H-2011-062-117

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 estimated patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

FreeStyle Libre (CGM) Group

Experimental group

Description:

Device: FreeStyle Libre (ver 1.0) Education on lifestyle modification

Treatment:

Device: FreeStyle Libre

Self Monitoring of Blood Glucose (SMBG) Group

Active Comparator group

Description:

Device: Blood glucose meter Education on lifestyle modification

Treatment:

Device: Blood glucose meter