Comparison of Clinical Decisions and Outcomes Employing a Treat to Target Design for Subjects With Type 2 Diabetes Randomized to Either SMBG or CGM
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Percentage Change in Hemoglobin A1c
研究概览
简要总结
The purpose of this study is to evaluate the use of SMBG and CGM for clinical decisions related to the management of type 2 diabetes. The secondary objective is to determine the benefit of using CGM for clinical diabetes management decision-making.
详细描述
This study involves the use of the following 2 glucose monitoring methods to measure your blood sugar (glucose) levels and help manage type 2 diabetes:
- Self Monitoring Blood Glucose (SMBG): blood glucose is measured 4-7 times each day using finger sticks and an blood glucose meter.
- Continuous Glucose Monitoring (CGM): blood glucose is measured continuously via the CGM device. This device has been approved for use by the U.S. Food and Drug Administration (FDA).
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 and ≤75 years of age (Upper range to assure dexterity for use of CGM)
- •Clinical diagnosis of type 2 diabetes
- •HbA1c ≥7.0%
- •Diabetes can be treated with any of the following therapies within one month prior to study enrollment: (1) medical nutrition therapy alone or with metformin; (2) sulfonylurea with or without metformin; (3) dipeptidyl peptidase 4 (DPP-4) inhibitor or Glucagon-like peptide-1 (GLP-1) agonist with or without metformin; or insulin with or without metformin.
排除标准
- •Treated with Thiazolidinediones (TZD)
- •Administered prednisone or cortisone medications in the previous 30 days
- •Currently pregnant or planning pregnancy during the study period
- •Presence of any severe medical or psychological condition or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- •HbA1c <7.0%
- •Unable to follow the study protocol
- •Unable to speak, read and write in English
研究组 & 干预措施
CGM Group
Wear an unblinded CGM for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use real time continuous glucose monitoring (rt CGM).
干预措施: CGM Group (Device)
SMBG Group
Use SMBG 4 to 7 times a day for 16 weeks. Subjects continued previously started medication regiments for their diabetes. Subjects in this arm were randomized to use structured self monitoring blood glucose (stSMBG) and periodic, blinded continuous glucose monitoring (CGM).
干预措施: SMBG Group (Device)
结局指标
主要结局
Percentage Change in Hemoglobin A1c
时间窗: 2 week baseline to 16 week final
次要结局
- Glucose Exposure (Area Under the Diurnal Median Curve)(16 weeks)
- Percent of Time in Hypoglycemia Range(16 weeks)
- Change From Baseline in CGM Glucose Variability(Baseline and 16 weeks)