Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FreeStyle Libre, Blood glucose meter.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Type 2, Lifestyle Risk Reduction. Basic parameters: 19 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device FreeStyle Libre
Flash glucose monitoring + Education on lifestyle modification - Device Blood glucose meter
Self monitoring of blood glucose + Education on lifestyle modification
Primary outcome measures
- Change in HbA1c [Time frame: Baseline to Month 3]
Secondary outcome measures (6)
- Change in mean fasting glucose [Time frame: Baseline to Month 3]
- Change in body weight [Time frame: Baseline to Month 3]
- Change in blood pressure [Time frame: Baseline to Month 3]
- Change in waist circumference [Time frame: Baseline to Month 3]
- Change in lipid level [Time frame: Baseline to Month 3]
- Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score [Time frame: Baseline to Month 3]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
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. PMID 35984640
Identifiers
NCT: NCT04932928 · H-2011-062-117