NCT01548222已完成不适用
CGM Evaluation of Glucose Excursions in Basal Insulin Treated T2DM at Fasting Glucose Target
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Percentage of time CGM glucose is <70mg/dl
研究概览
简要总结
This is a trial to determine if patients who are well controlled and on basal insulin are treated with excessive basal dose.
详细描述
In many clinical trials, basal insulin is titrated to only a fasting glucose goal. The usual final dose is >0.4U/kg. In carefully CGM monitored/titrated studies in both basal insulin alone or in pump-treated T2DM, we have found the basal insulin dose to be <0.3U/kg. This suggests that if guided by a single daily fasting glucose, titration may result in an excessive basal dose. This study will examine that issue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Type 2 diabetes
- •Age 18 years and above
- •Concurrently on +/-thiazolidnedione +/-DDP IV inhibitors +/-metformin +/- glinides and basal insulin analogs
- •A1C 10% or below
- •Capable of self monitoring glucose at least 4 x a day
- •Previously compliant with clinical recommendations
- •Fasting blood glucose <110mg/dl average for 3 consecutive days
- •BMI <45 kg/m
排除标准
- •Urinary ketosis
- •Current or expected alternation in insulin sensitivity such as major surgery, infection, renal failure, glucocorticoid treatment, recent serious hypoglycaemic episode
- •Currently participating in another clinical trial
- •Using rapid insulin insulin
- •Pregnancy or nursing or the intention of becoming pregnant or not using adequate birth control
- •Significant liver or heart failure.
结局指标
主要结局
Percentage of time CGM glucose is <70mg/dl
时间窗: the subject will be followed for 9 days
The percentage of time CGM glucose is \<70 mg/dl during the basal glucose evaluation
次要结局
- Percentage of time CGM glucose is <40 mg/dl(the subject will be followed for 9 days)
- Determined hypoglycaemic episodes(the subject will be followed for 9 days)
- Weight gain(the subject will be followed for 9 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Pilot Study of Glycemic Control in Diabetic Hemodialyzed PatientsDiabetes MellitusNCT01828970Centre Europeen d'Etude du Diabete38
已完成
不适用
Validation of Algorithms for Basal Insulin Rate Reductions in Type 1 Diabetic Patients Practising Physical ActivityType 1 Diabetes With a Subcutaneous Insulin PumpAdjustment of the Recommended Basal Insulin Flow Rate in the Event of Physical ActivityAdjustment of the Recommended Prandial Insulin in the Event of Physical ActivityNCT01277965Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète20
已完成
1 期
A Study to Compare Methodologies for Assessing Glucose-Dependent Insulin Secretion (0000-104)(COMPLETED)The Methodology Assessment of Glucose Dependent Insulin SecretionNCT00782418Merck Sharp & Dohme LLC27
已完成
4 期
Basal Insulin in the Management of Patients With Diabetic Ketoacidosis (DKA)Diabetic KetoacidosisNCT00590044Emory University74
已完成
4 期
Insulin Schemes for Type 2 Diabetes ControlType 2 Diabetes MellitusNCT03350984Universidad de Guanajuato75