Replication of the SEPRA Diabetes Trial in Healthcare Claims Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,316
- 试验地点
- 1
- 主要终点
- Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol)
研究概览
简要总结
Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
详细描述
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
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
- •Age >= 18
- •Type 2 diabetes mellitus diagnosis
- •Use of metformin
- •At least 2 HbA1c records within the prior 280 days
- •At least 1 HbA1c record >= 7% within the prior 90 days
排除标准
- •Missing age or gender
- •Use of any other anti-diabetes medications
- •Any insulin use
- •Pregnancy
- •Multiple Endocrine Neoplasia syndrome type 2
- •CKD stage 5, ESRD, dialysis, or renal transplant
- •Nursing home admission
研究组 & 干预措施
New initiation of "standard of care"
(SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) Reference group
干预措施: New initiation of "standard of care" (SGL2i, 2nd generation SU, DPP-4i and GLP-1 RA except for semaglutide inj or oral) (Drug)
New use of semaglutide injection
Exposure group
干预措施: New use of semaglutide injection (Drug)
结局指标
主要结局
Long-term glycemic control defined as proportion of patients who will achieve an HbA1c of less than 7.0% (53.0 mmol/mol)
时间窗: At year 1
Number of subjects
次要结局
- Number of hypoglycemic episodes leading to an inpatient admission or emergency room encounter.(At 1 year)
- Change in HbA1c(At 1 year)
研究者
Shirley Vichy Wang
Associate Professor of Medicine
Brigham and Women's Hospital