Management of Inpatient Hyperglycemia by Continuous Glucose Monitoring in Insulin-treated Patients With Diabetes: Dexcom G6 Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 6
- 主要终点
- Mean Daily Blood Glucose (BG) Concentration While Hospitalized
研究概览
简要总结
The study will assess if Continuous Glucose Monitoring (CGM) represents a better tool to guide healthcare providers in adjusting insulin therapy, by providing a more complete 24-hour assessment of glucose values compared to Point of Care (POC) testing, during hospitalization and after hospital discharge in general medicine and surgery patients with Type 2 Diabetes (T2D) and Type 1 Diabetes (T1D).
详细描述
Diabetes is reported in 20-34% of hospitalized adult patients in general medicine and surgery units and there is a large body of literature showing a strong association between diabetes and increased hospital mortality and morbidity. Clinical guidelines have recommended the use of basal bolus insulin regimens as the preferred management approach of non-intensive care unit (ICU) patients with diabetes, as it has been shown to be effective in improving glycemic control and reducing hospital complications. However, hypoglycemia is a common adverse event of insulin therapy, with incidence rates ranging between 12% and 35% in randomized studies in non-ICU settings. The development of hypoglycemia, like hyperglycemia, has been associated with higher rates of hospital complications, higher health care resource utilization, and hospital mortality.
Bedside point-of-care (POC) capillary glucose monitoring is the standard of care to assess glycemic control in the hospital. Diabetes guidelines recommend bedside capillary POC testing before meals and at bedtime to assess glycemic control and to adjust insulin therapy in the hospital. In contrast to POC testing, continuous glucose monitoring (CGM) measures interstitial glucose every 5-15 minutes, thus providing a more complete glycemic profile during 24-hours compared to standard POC glucose testing. The study will assess if CGM represents a better tool to guide healthcare providers in adjusting insulin therapy by providing a more complete 24-hour assessment of glucose values compared to POC testing, during hospitalization and after hospital discharge in general medicine and surgery patients with T2D and T1D.
Participants will be randomized to have the standard of care POC testing plus wear a sham CGM or to wear a real-time Dexcom G6 CGM, which provide BG readings every 5 minutes for up to 10 days during hospitalization. At the point of hospital discharge, participants with poorly controlled diabetes will be invited to participate in an open label outpatient study where they will wear a Dexcom G6 CGM or sham device for 10 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Males and females ≥ 18 years admitted to a general medicine or surgical services.
- •History of T1D or T2D receiving insulin therapy during hospital admission.
- •Subjects must have a randomization BG <400 mg/dL without laboratory evidence of diabetic ketoacidosis (bicarbonate < 18 milliequivalents per litre (mEq/L), potential of hydrogen (pH) < 7.30, or positive serum or urinary ketones).
- •Patients with expected hospital length-of-stay of 2 or more day
排除标准
- •Patients with acute illness admitted to the ICU or expected to require admission to the ICU.
- •Patients expected to require MRI procedures during hospitalization.
- •Patients with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension), corticosteroid therapy, end-stage renal disease (dialysis), or anasarca (massive peripheral edema).
- •Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- •Female subjects who are pregnant or breast-feeding at time of enrollment into the study.
- •Coronavirus Disease 2019 (COVID-19) infection
结局指标
主要结局
Mean Daily Blood Glucose (BG) Concentration While Hospitalized
时间窗: During hospitalization (up to 10 days)
A random (non-fasting) blood glucose measurement of 140 mg/dL or less is considered normal, while a measurement of 200 mg/dL or more indicates diabetes.
Percent of Time With BG Between 70-180 mg/dL While Hospitalized
时间窗: During hospitalization (up to 10 days)
Glycemic control is measured by the percent of time with BG in the range of 70-180 mg/dL.
Number of Clinically Significant Hypoglycemia Events While Hospitalized
时间窗: During hospitalization (up to 10 days)
The mean number of clinically significant hypoglycemia events, defined as BG \<54 mg/dl (3.0mmol/L), per participant is presented here.
次要结局
- Number of Hypoglycemia Events While Hospitalized(During hospitalization (up to 10 days))
- Percent of Time With Hyperglycemia While Hospitalized(During hospitalization (up to 10 days))
- Differences in BG by CGM Devices Placed in the Abdomen and Upper Extremity While Hospitalized(During hospitalization (up to 10 days))
- Number of Clinically Significant Hypoglycemia Events After Discharge(After hospital discharge (up to 10 days))
- Number of Hypoglycemia Events After Discharge(After hospital discharge (up to 10 days))
- Number of Nocturnal Hypoglycemia Events While Hospitalized(During hospitalization (up to 10 days))
- Percent of Time With BG Between 70-180 mg/dL After Discharge(After hospital discharge (up to 10 days))
- Percent of Time With Hypoglycemia While Hospitalized(During hospitalization (up to 10 days))
- Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) While Hospitalized(During hospitalization (up to 10 days))
- Number of Sensor Changes During Hospitalization(During hospitalization (up to 10 days))
- Mean Daily BG Concentration After Discharge(After hospital discharge (up to 10 days))
- Count of Participants With Hypoglycemia After Discharge(After hospital discharge (up to 10 days))
- Percent of Time With Hyperglycemia After Discharge(After hospital discharge (up to 10 days))
- Glycemic Variability Calculated by Mean Amplitude of Glycemic Excursions (MAGE) After Discharge(After hospital discharge (up to 10 days))
研究者
Guillermo Umpierrez
Professor
Emory University