Patient-Driven Lifestyle Modification Using FreeStyle Libre in Type 2 Diabetes Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19-80
- •Diagnosed with type 2 diabetes mellitus (DM)
- •Uncontrolled type 2 DM: HbA1c 7.0-10.0%
- •Signed informed consent
排除标准
- •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
结局指标
主要结局
Change in HbA1c
时间窗: Baseline to Month 3
Between group differences (CGM and SMBG) for the change in HbA1c from baseline to Month 3
次要结局
- Change in lipid level(Baseline to Month 3)
- Change in body weight(Baseline to Month 3)
- Change in mean fasting glucose(Baseline to Month 3)
- Change in blood pressure(Baseline to Month 3)
- Change in waist circumference(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)