Canadian Real-World Outcomes of Omnipod Initiation in People With T1D: Evidence From the LMC Diabetes Registry: The COPPER Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 286
- 试验地点
- 1
- 主要终点
- Glycated hemoglobin (A1C)
研究概览
简要总结
The current study aims to assess clinical outcomes in adults with type 1 diabetes (T1D) who have switched from traditional multiple daily injection (MDI) therapy to continuous subcutaneous insulin infusion (CSII) therapy with the Omnipod insulin system.
详细描述
Poor glycemic control is associated with increased risk of diabetes-related complications in persons with type 1 diabetes (T1D). Despite advancements in insulin therapies and an increase in diabetes technology use, only 21% of adults with T1D are meeting their targeted glycated hemoglobin (A1C) levels. The Omnipod insulin system is a patch pump that consists of a handheld controller and disposable pod that delivers insulin. A retrospective analysis of medical records in the United States found that there was a significant reduction in A1C three months after initiating Omnipod in pediatric, adolescent and adult populations with T1D who switched from either MDI or traditional CSII. Currently, the real-world effectiveness of the Omnipod compared to MDI in adults with T1D on glycemic control, weight, and insulin dose, is not established.
The Canadian Real-World Outcomes of Omnipod Initiation in People with T1D: Evidence from the LMC Diabetes Registry (COPPER) study is a retrospective, observational study using demographic and clinical data from the LMC Diabetes Registry, which consists of over 42,000 active patients with diabetes across 3 Canadian provinces. The overall objectives of this study are to assess clinical outcomes in adults with T1D who switch from MDI to CSII therapy with Omnipod, and to compare clinical outcomes in the Omnipod cohort to a matched cohort of MDI users.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T1D ≥ 12 months prior to initiating the Omnipod
- •Age ≥ 18 years
- •Switched from MDI to Omnipod (Omnipod cohort)
- •Persistent with OmniPod treatment for ≥ six months
- •No change in basal insulin type or bolus insulin type between baseline and follow up (matched MDI cohort)
- •≥ one A1C measurement during the baseline and follow-up period
排除标准
- •Switched from traditional CSII to OmniPod
- •Use of non-insulin diabetes therapies
结局指标
主要结局
Glycated hemoglobin (A1C)
时间窗: Three to six months from baseline
Change in A1C (%). A1C will be retrieved from the participants electronic medical records.
次要结局
- Proportion of patients achieving A1C < 8.0%(Three to six months from baseline)
- Proportion of patients achieving A1C < 7.0%(Three to six months from baseline)
- Weight(Three to six months from baseline)
- Body mass index (BMI)(Three to six months from baseline)
- Total daily dose (TDD) of insulin(Three to six months from baseline)
- Weekly incidence of hypoglycemia(Three to six months from baseline)
- Annual incidence of severe hypoglycemia(Three to six months from baseline)