Actively Recruiting
Led by Seoul National University Hospital · Updated on 2021-06-21
126
Participants Needed
1
Research Sites
25 weeks
Total Duration
S
Seoul National University Hospital
Lead Sponsor
I
Inje University
Collaborating Sponsor
Researchers are evaluating the effects of medical nutritional therapy combined with glucose monitoring methods in patients with type 2 diabetes who are on oral hypoglycemic agents or basal insulin only. This randomized, open-label, controlled study focuses on individuals with type 2 diabetes who have an HbA1c between 7.0% and 10.0%, aiming to compare the impact of continuous glucose monitoring versus self-monitoring of blood glucose on glycemic control. The study involves 126 participants randomized equally into two groups. One group will use the FreeStyle Libre continuous glucose monitoring device for 12 weeks alongside education on lifestyle modification. The other group will use a traditional blood glucose meter combined with similar lifestyle education. Both groups will receive structured phone reminders every 4 weeks to support adherence. After 12 weeks, participants will return for final laboratory tests and surveys. Participants will attend baseline and 12-week follow-up visits including laboratory examinations such as HbA1c measurement and surveys on diabetes self-care activities. Researchers will monitor changes in HbA1c, fasting glucose, body weight, blood pressure, waist circumference, lipid levels, and self-care behaviors. The study aims to assess how different glucose monitoring methods influence diabetes management over the 3-month period.
CONDITIONS
Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 12 weeks
Participants use either the FreeStyle Libre continuous glucose monitoring device or a blood glucose meter along with personalized education on lifestyle modification. Structured phone visits occur every 4 weeks to provide reminders and support.
1 baseline visit and monthly phone visits every 4 weeks
Duration - At 12 weeks after treatment start
Participants complete the study with a final visit including laboratory examinations and surveys to assess changes from baseline.
1 final visit (in-person)
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea, 110-744
Actively Recruiting
H
Hun Jee Choe, MD
Y
Young Min Cho, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Hun Jee Choe, Eun-Jung Rhee, Jong Chul Won...
https://pubmed.ncbi.nlm.nih.gov/35984640