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临床试验/NCT04371497
NCT04371497已完成不适用

Three-year Retrospective Study on the Switch From Rapid-acting Insulin Analog to Concentrated U-500 Regular Insulin in Insulin-resistant Type 2 Diabetes Patients Treated by Pump Therapy

University Hospital, Caen0 个研究点目标入组 65 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
主要终点
differential HbA1c before and after insulin switch

研究概览

简要总结

The aim of the study was to perform a 3-year retrospective analysis from a cohort of patients with type 2 diabetes that were treated by a pump device and were uncontrolled despite high U-100 insulin requirements. The study reports outcomes after the switch from U-100 U/ml Rapid-Acting Analog to U-500 U/ml Regular Insulin, both administered by Continuous Subcutaneous Infusion.

详细描述

This study is a retrospective evaluation of a cohort of patients with Type 2 Diabetes from six French centers, who were previously treated by insulin pump therapy, and then switched from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin (Eli Lilly Inc, France) between June 2011 and September 2017. All participants had been previously treated by Multiple Daily Insulin injections and then had been treated by Continuous Subcutaneous Insulin Infusion with U-100 Rapid Acting Insulin analog administered by an insulin pump. Patient's selection criteria included an insulin-resistant state defined by a Total Daily insulin Dose greater than 100 U per day, and a switch from U-100 Rapid Acting Insulin analog to 500 U/mL Regular Insulin during the study period. Data collection from patient medical records included HbA1c, lipid levels, weight, Total Daily insulin Dose, and the recordings of hypoglycemia episodes. Outcomes were recorded at different timelines including baseline and 6, 12, 24 and 36-months after the switch from U-100 to U-500 insulin. Blinded continuous glucose monitoring (CGM) (ipro2, Medtronic Inc., USA) was analyzed in a subgroup of patients having CGM data available at baseline on U-100 insulin and after 6-months on U-500 insulin.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
35 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • T2D diabetes
  • Pump therapy with U-100 U/ml rapid-acting analog prior to initiation of U-500 U/ml insulin
  • Total daily Insulin dose > 100 U per day

排除标准

  • follow up < 3 months

结局指标

主要结局

differential HbA1c before and after insulin switch

时间窗: baseline, 1-year, 2-years, 3-years

HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-HbA1c comparison between baseline and 1, 2, 3 year(s) after the switch to U-500 insulin

次要结局

  • Continuous Glucose Monitoring before and after insulin switch(baseline, 6-month)
  • Lipids(baseline, 1-year, 2-years, 3-years)
  • Hypoglycemia events(baseline, 1-year, 2-years, 3-years)
  • Total Daily Insulin Dose(baseline, 1-year, 2-years, 3-years)
  • Body Weight(baseline, 1-year, 2-years, 3-years)

研究者

申办方类型
Other
责任方
Sponsor

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