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临床试验/NCT00869414
NCT00869414终止不适用

Comparison of Glycemic Response to Morning Only, Evening Only or Twice Daily Insulin Glargine in Patients With Type 1 Diabetes Using Continuous Glucose Monitoring

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
16
试验地点
1
主要终点
Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)

研究概览

简要总结

This research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (Lantus®) on hypoglycemia (blood glucose level <70 mg/dL) as measured by continuous glucose monitoring (CGM) in patients with type 1 diabetes.

详细描述

Over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. After 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. Through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). The vials will be labeled MORNING or EVENING. Patients will continue to take their mealtime, short acting insulin doses.

Additionally, patients will wear a continuous glucose monitor (CGM) which will be masked. Before the study, patients will be taught about how to use the CGM, and keep it taped to their abdomen. The site that the CGM inserts into their abdomen will need to be changed every 5 days. We will know if a patients' blood sugar goes low even if the patient did not feel the low. Patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the CGM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus
  • On multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation.
  • Clinical history consistent with hypoglycemia
  • Hba1c <9.0%

排除标准

  • Patients with type 2 diabetes mellitus
  • Patients on insulin pump
  • Poor control of diabetes (HbA1c > 9.0%)
  • Pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). Insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed.
  • Serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., CRF) or safety (e.g., recent CAD)

研究组 & 干预措施

insulin glargine only in morning

Active Comparator

Morning only administration of insulin glargine

干预措施: Morning only administration of insulin glargine (Drug)

insulin glargine only at evening

Active Comparator

Evening only administration of insulin glargine

干预措施: Evening only administration of insulin glargine (Drug)

split dose insulin glargine

Active Comparator

Split dose administration of insulin glargine, half dose in morning, half dose in evening

干预措施: split dose insulin glargine (Drug)

结局指标

主要结局

Time Spent (Mean Number of Minutes Per 24 Hour Day) in Hypoglycemic Range (<70mg/dl)

时间窗: 6 weeks

Change in the Mean Minutes Per 24 Hour Day in the Hyperglycemic Range of > 180 mg/dL.

时间窗: 6 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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