Effect of the Use of Continuous Glucose Monitoring Versus Standard Glycemic Control for Insulin Therapy Adjustment and Decision Making in Noncritical Patients with Type 2 Diabetes Hospitalized in Medical and Surgical Wards.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission.
研究概览
简要总结
Type 2 diabetes (T2D) is a common pathology in hospitalized patients and is associated with multiple comorbidities. Moreover, it is widely known that glycemic excursions increase hospital stay, infections, morbidity and mortality. Likewise, asymptomatic hypoglycemia and stress hyperglycemia in hospitalized patients is more frequent due to intercurrent pathology, medication, alteration of counter-regulatory hormones. Therefore, the use of continuous glucose monitoring (CGM) systems would be very useful as it allows early recognition of glycemic excursions and thus improve the management of insulin therapy. The primary objective is to demonstrate the increase in time in range (TIR) with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission. The investigators randomized, parallel group, 2-arm, 40 participants; 20 in each group, patients with diagnosis of T2D prior to admission.
详细描述
Over the past few decades advances in diabetes technology have revolutionized patient care and metabolic control. The use of CGM has demonstrated substantial benefits on glycemic control in ambulatory patients compared to standard capillary blood glucose (CG) monitoring. However, in hospitalized patients, limitations on its use persist due to the lack of standardization of the data provided by CGM.
The use of CG has been the mainstay for monitoring and adjusting the treatment of hospitalized patients with diabetes. In the management for inpatients this test is commonly performed 3 to 4 times a day. However, this provides significant limitations due to its intermittent nature and the associated time burden for hospital nursing and ancillary staff for its determination.
Several studies have demonstrated that CGM detects more hyperglycemia and hypoglycemia in critically ill and non-critically ill patients. These studies have provided important information on patterns of glycemic control, with emphasis on early detection of glycemic excursions. However, there is still a need for further research to determine the efficacy of their use in glycemic adjustment, reliability in the hospital setting, and standardized protocols for their implementation and decision-making.
HYPOTHESIS The use of CGM allows an increase in TIR and improves the detection of clinically significant hypoglycemia and hyperglycemia in patients with T2D hospitalized on basal-bolus insulin therapy versus standard CG.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years old
- •Admitted to medical or surgical wards with an expected hospitalization duration of more than 72 hours
- •Requiring basal-bolus insulin therapy during hospitalization.
排除标准
- •Pregnant women
- •Severe mental illnesses
- •Chronic use of high doses of ascorbic acid (equivalent to more than 500mg/day)
- •Patients hospitalized in Intensive Care Units
- •Severe cognitive impairment
- •Prior outpatient CGM use
- •Refusal of informed consent
- •Patients on prolonged absolute diets or receiving artificial nutrition
结局指标
主要结局
The primary objective is to demonstrate the increase in TIR with the use of CGM for insulin therapy adjustment in hospitalized patients with T2D during their admission.
时间窗: The days of sensor use during hospitalization (from 3 to 14 days).
-Time in range (TIR) reported at the end of sensor use: results will be expressed in percentages and levels greater than 70% will be considered good glycemic control.
次要结局
未报告次要终点
研究者
Olga Gonzalez Albarran
Principal Investigator, PhD, MD, Specialist in Endocrinology
Hospital General Universitario Gregorio Marañon
