A Randomized Controlled Trial Comparing Dexcom Continuous Glucose Monitoring to Point of Care Glucose Testing for the Management of Hospital and Post-Discharge Subjects With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
This study aims to compare inpatient glycemic control by measuring the percentage of time in the range of 70-180 mg/dl and the frequency of hypoglycemia between Dexcom G7 Continuous Glucose Monitoring (CGM) and Point of Care (POC) Blood Glucose Testing in poorly controlled subjects with Type 1 Diabetes Mellitus.
The main question it aims to answer is:
-Whether there is a difference between POC testing (standard of care) and Real-time CGM in glycemic control and hypoglycemic events during hospitalization:
详细描述
The CDC reports that 1.6 million U.S. adults (5.7%) have type 1 diabetes (T1D), with hospitalization rates three times higher than the general population, primarily due to diabetes-related complications such as ketoacidosis and cardiovascular disease. A study at Emory University found that hospitalized T1D patients are younger, experience longer stays and more admissions, and face worse glycemic control and higher rates of hypoglycemia compared to type 2 diabetes (T2D) patients.
Point-of-care (POC) capillary glucose testing is the standard for monitoring hospitalized diabetes patients, but continuous glucose monitoring (CGM) offers more detailed glycemic profiles. Research, including trials using Dexcom CGM systems, has demonstrated CGM's superior ability to detect hypo- and hyperglycemia, reduce hypoglycemic events, and improve insulin therapy adjustments in T2D patients. However, no randomized controlled studies have evaluated the best glucose monitoring system for hospitalized T1D patients.
The proposed study aims to compare POC testing with Dexcom G7 CGM for guiding insulin therapy in hospitalized T1D patients. Researchers hypothesize that CGM will better prevent hypoglycemia and improve glycemic management during hospital stays, addressing a critical gap in evidence regarding glucose control's impact on T1D hospital outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Known history of T1D treated with insulin therapy (human regular or rapid-acting analogs or ultra-rapid analogs [lispro, aspart, glulisine, fast-acting insulin aspart, insulin lispro]), intermediate-acting (NPH and premixed formulations) or long-acting basal (glargine, detemir, degludec) formulations.
- •Admission diagnosis of T1D with poorly controlled diabetes (blood glucose > 180 mg/dl, HbA1c > 7%), including diabetic ketoacidosis (DKA) and hyperglycemic hyperosmolar state (HHS).
- •Expected length of hospital stay > three days at the time of randomization
排除标准
- •Patients admitted to the ICU
- •Subjects using CGM technology before admission
- •Subjects with type 2 diabetes
- •Treatment with systemic immunosuppressive agents
- •Cystic fibrosis
- •Prisoners
- •Patients expected to require MRI procedures during hospitalization.
- •Female subjects who are pregnant or breastfeeding at enrollment into the study.
- •Subjects not willing to wear a CGM device
- •Subjects with clinically relevant hepatic disease (diagnosed liver cirrhosis and portal hypertension) and end-stage kidney disease (eGFR< 30 ml/min), or terminal illness.
- •Subjects with a history of cognitive impairment, dementia, or mental condition rendering the subject unable to understand the nature and consequences of the study
研究组 & 干预措施
Standard of Care
Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) with intravenous or subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Glucose monitoring by POC testing will be performed before meals and at bedtime. Results will be uploaded to the electronic medical record (EMR) system. The research team, together with the Primary care (PCP) team, will adjust daily insulin orders based on POC readings (standard of care). In addition, subjects will wear a 'blinded' CGM (no results will be visualized by patients, nursing staff, medicine, or research teams) during hospitalization for up to 10 days.
干预措施: Capillary Blood glucose Testing (POC) (Diagnostic Test)
Dexcom CGM
Severe hyperglycemia will be managed by primary care professionals (Hospitalist Service) intravenously with subcutaneous insulin therapy. Subjects will be invited to participate in the study after the resolution of severe hyperglycemia (BG < 400 mg/dl). Subjects will wear a real-time Dexcom G7 CGM for up to 10 days. Insulin therapy will be titrated based on daily CGM reports, including mean glucose, glycemic excursions, hypoglycemia, and severe hyperglycemia > 180 and >250 mg/dl values. Participants will wear a Dexcom rtCGM for up to 10 days during hospitalization.
干预措施: Dexcom G7 rtCGM (Device)
结局指标
主要结局
Glycemic control
时间窗: Through study completion (Day 10 or the length of admission)
The total difference in blood sugar levels between the POC testing (standard of care) group and the rtCGM group throughout the hospitalization
Clinically significant hypoglycemia <54 mg/dl
时间窗: Through study completion (Day 10 or the length of admission)
The difference between blood sugar levels in POC testing (standard of care) group and rtCGM group during hospitalization
次要结局
- Hypoglycemic events(Through study completion (Day 10 or the length of admission))
- Hyperglycemic events(Through study completion (Day 10 or the length of admission))
- Nocturnal hypoglycemia(Through study completion (Day 10 or the length of admission))
- Prolonged hypoglycemia(Through study completion (Day 10 or the length of admission))
- Time above range(Through study completion (Day 10 or the length of admission))
- Time below range(Through study completion (Day 10 or the length of admission))
- Glycemic Variability [% Coefficient of Variation (%CV)(Through study completion (Day 10 or the length of admission))
- Hospital Complications(Through study completion (Day 10 or the length of admission))
- Recurrent hypoglycemia(Through study completion (Day 10 or the length of admission))
- Recurrent hyperglycemia(Through study completion (Day 10 or the length of admission))
研究者
Guillermo Umpierrez
Professor
Emory University