Clinical trial NCT04932928: Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Official title: Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lifestyle Risk Reduction
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Inje University
name: Kangbuk Samsung Hospital
First posted: 2021-06-21
Enrollment: 126
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c
timeFrame: Baseline to Month 3
Secondary outcomes:
measure: Change in mean fasting glucose
timeFrame: Baseline to Month 3
measure: Change in body weight
timeFrame: Baseline to Month 3
measure: Change in blood pressure
timeFrame: Baseline to Month 3
measure: Change in waist circumference
timeFrame: Baseline to Month 3
measure: Change in lipid level
timeFrame: Baseline to Month 3
measure: Change in the Korean Version of Revised Summary of Diabetes Self-Care Activities Questionnaire (SDSCA-K) survey score
timeFrame: Baseline to Month 3
Other outcomes:
measure: Change in CGM time in target range
timeFrame: Baseline to Month 3
measure: Change in CGM time-hyperglycemic
timeFrame: Baseline to Month 3
measure: Change in CGM time-hypoglycemic
timeFrame: Baseline to Month 3
measure: Change in CGM glucose variability
timeFrame: Baseline to Month 3
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.