In-hospital Diabetes Management by a Diabetes Team and Continuous Glucose Monitoring or Point of Care Glucose Testing (DIATEC): a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 4
- 主要终点
- Time in range
研究概览
简要总结
This trial investigates the effects of continuous glucose monitoring (CGM) and an in-hospital diabetes team on in-hospital glycemic and clinical outcomes in patients with type 2 diabetes compared to standard glucose point-of-care (POC) testing and an in-hospital diabetes team.
详细描述
In Denmark and worldwide, 15-20 % of hospitalised patients have diabetes mellitus. For most patients, diabetes is not the primary cause of admission. The patients are therefore under the care of non-diabetes specialists. Consequently, diabetes management can be inadequate resulting in hypoglycemia, hyperglycemia, and increased glycemic variability, which might increase patient mortality, morbidity, and length of hospital stay. Despite these challenges, a recent review concludes that in-hospital diabetes management is under-researched. Therefore, new in-hospital diabetes management strategies are greatly needed.
Continuous glucose monitoring (CGM) might accommodate this need by providing 288 glucose readings per day compared to usual glucose point-of-care (POC) testing from finger-prick blood 3-5 times per day during admission. CGM glucose levels can be transmitted from the patient's room to a monitoring screen at the nursing stations. This setup is called telemetric CGM. Outstanding results on glycemic and clinical outcomes in an out-hospital setting exist, however, In-hospital CGM has been associated only with a clinically insignificant reduction of mean daily glucose levels and a small increased detection rate of hypoglycemia of glucose levels <3 mmol/L (<54 mg/dL) compared to POC. Reasons for this might be that an in-hospital diabetes team (i.e., educated diabetes nurses with CGM competencies) is imperative in achieving optimal use of telemetric CGM.
This trial investigates if telemetric CGM and an in-hospital diabetes team improve patients' in-hospital glycemic and clinical outcomes compared to POC glucose testing and an in-hospital diabetes team
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A documented history of T2DM prior to inclusion
- •Age ≥ 18 years old
- •Willingness and ability to comply with the clinical investigation plan
- •Ability to communicate in Danish with the trial personnel
- •An expected length of hospital stay for at least two days after enrolment
- •If subject with childbearing potential (subject < 50 years old); willing to have a urine pregnancy test performed and/or to use a highly effective method of contraception (i.e., birth control implant, intrauterine device, birth control shot, or sterilisation).
排除标准
- •Patients on out-hospital basal insulin with duration of action > 24 hours (Toujeo or Tresiba)
- •Treated with hydroxyurea/hydroxycarbamid
- •Nutritional therapy (continuous enteral or parenteral feeding)
- •Clinically relevant pancreatic disease
- •Systemic glucocorticoid treatment with prednisone equivalent dose >5 mg/day
- •Expected to require admission to the intensive-care unit
- •Anasarca (severe and general edema)
- •Estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m2
- •Known hypersensitivity to the band-aid of the CGM Dexcom G6 sensor.
研究组 & 干预措施
POC-arm
Subjects are monitored by point-of-care (POC) glucose testing. Diabetes management is done by usual ward nurses and guided by an in-hospital diabetes team. A blinded CGM is mounted in the POC-arm for outcome analysis.
干预措施: FreeStyle Precision Pro Glucometer for glucose POC testing (Device)
CGM-arm
CGM-arm subjects are monitored by CGM viewed by the in-hospital diabetes team in addition to POC glucose testing performed by usual ward nurses. Diabetes management is done by usual ward nurses by POC glucose testing and guided by an in-hospital diabetes team with acces to CGM data.
干预措施: Dexcom G6 Continuous Glucose Monitoring System (Dexcom Inc., San Diego, USA) (Device)
结局指标
主要结局
Time in range
时间窗: During hospitalization (up to 30 days)
Time in range (TIR) is defined as the percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.
次要结局
- Time below range (TBR) <3.0 (<54 mg/dL)(During hospitalization (up to 30 days))
- Hypoglycemia < 3.9 mmol/L (< 70 mg/dL)(During hospitalization (up to 30 days))
- Time in range per day 3.9-10.0 mmol/L (70-180 mg/dL)(During hospitalization (up to 30 days))
- Standard deviation (SD) of all CGM glucose levels(During hospitalization (up to 30 days))
- Mean glucose levels(During hospitalization (up to 30 days))
- Time above range (TAR) >10.0 mmol/L (>180 mg/dL)(During hospitalization (up to 30 days))
- Coefficient of variation (CV)(During hospitalization (up to 30 days))
- Time above range (TAR) >13.9 mmol/L (>250 mg/dL)(During hospitalization (up to 30 days))
- Time below range (TBR) <3.9 mmol/L (<70 mg/dL)(During hospitalization (up to 30 days))
- Hypoglycemia (level 1) 3.0-3.8 mmol/L (54-69 mg/dL)(During hospitalization (up to 30 days))
- Hypoglycemia (level 2) < 3.0 mmol/L (<54 mg/dL)(During hospitalization (up to 30 days))
- Recurrent hypoglycemic events(During hospitalization (up to 30 days))
研究者
Peter Kristensen
Medical Doctor, PhD, Clinical Associate Professor
Nordsjaellands Hospital