Blutzucker-Nachtprofile Mit Wecker Und Selbstmessungen gegenüber Fremdmessungen Durch Spezialisiertes Pflegepersonal: Eine Analyse Mittels Kontinuierlichem Glukose-Monitoring (Glucoday®)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Glucose (continuous glucose monitoring)
研究概览
简要总结
Study hypothesis: Waking up in response to an alarm clock may evoke a stress reaction that leads to rising glucose concentrations.
The purpose of this study was to prove this hypothesis with continuous glucose monitoring over three nights.
Night (a) with an alarm clock set at 2 h intervals for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations, and
Night (c) with the patients left undisturbed.
详细描述
To provide nocturnal glucose control in patients with type 1 diabetes is a therapeutic challenge. Nocturnal glucose profiles are an important tool to secure adequate glycemic control during the night. Often, patients are asked to perform self-monitoring with the help of an alarm clock. Such a recommendation depends on the accuracy of glucose concentrations determined this way. We hypothesized that alarm clocks may trigger a stressful arousal that might be accompanied by rises in glucose concentrations, consecutively leading to nocturnal glucose profiles that are not representative for undisturbed conditions.
We want to prove this hypothesis with 30 patients over three nights.
Night (a) with an alarm clock set at 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m) for glucose self monitoring,
Night (b) with a nurse performing blood glucose determinations at the 2 h intervals (midnight, 2 a.m., 4a.m. and 6:45 a.m), and
Night (c) with the patients left undisturbed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Type 1 Diabetic patients (diagnosed longer than 2 years)
- •HBA1c 5,0 - 9,5 %
- •Age 18-75 years
- •Hospitalized patients
- •Male or female, if female exclusion of pregnancy or secure contraception
- •Body-Mass-Index 19-40 kg/m²
- •Patient is elucidated
- •Patients agreement
排除标准
- •Type 2-Diabetic patients or other forms of diabetes beside type 1 diabetes, diagnosed after the guidelines of the Deutsche Diabetes Gesellschaft
- •HbA1c < 5,0 % or > 9,5 %
- •A severe hypoglycemia with unconsciousness within the last 2 month
- •Body-Mass-Index < 19 or > 40 kg/m²
- •No patient agreement
- •Pregnancy (positive pregnancy test) or unsecured contraception.
- •Agina pectoris or acute myocardial infarct, as continuous problem
- •Inadequate treated arterial hypertension > 160 mmHg systolic and/or < 95 mmHg diastolic
- •Active tumor disease
- •Anemia hemoglobin < 11,5 g/dl
- •Treatment with steroids, sedative or anesthetics
- •Infection/fewer > 37.5 °C
- •Renal- malfunction (serum- creatinine > 1.5 mg/dl)
- •Liver- malfunction (GPT and AP > double of upper- limit)
- •Alcohol or drug abuse
- •Sleep disorder
- •Participation in clinical studies within the last 3 month
- •Other significant health dysfunctions, which would affect the outcome of this study
- •Incapable to conform the requirements of the protocol
结局指标
主要结局
Glucose (continuous glucose monitoring)
时间窗: 10 pm, midnight, 2 am, 4 am and 6:45 am continous glucose monitoring during three nights
次要结局
- Hormones (norepinephrine, cortisol, glucagon, growth hormone, prolactin), Pulse, Blood glucose(22 pm, midnight, 2 am, 4 am, 6:45 am)