Effectiveness and Safety of Glucose-lowering Drugs as an Adjunct to Insulin Therapy in Chinese Patients With Type 1 Diabetes: a Retrospective, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 主要终点
- HbA1c
研究概览
简要总结
To assess the real-world impact of glucose-lowering drugs (GLDs) as an adjunct to insulin in Chinese patients with type 1 diabetes (T1DM).
Does glucose-lowering drugs (GLDs) as an adjunct to insulin improve clinical outcomes in Chinese patients with type 1 diabetes (T1DM) when used long-term in real-world practice?
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The research group consists of T1DM patients who first used oral hypoglycemic drugs from January 2013 to June 2024 and had a glycated hemoglobin level of >= 7%; The control group consisted of T1DM patients who maintained only insulin treatment regimen and had glycated hemoglobin >= 7%;
- •Age >= 18 years old;
- •At least one recorded HbA1c value before the start of treatment;
- •Maintain medication regimen as needed from baseline to at least 3 months;
- •Record the first glycated hemoglobin value after treatment.
排除标准
- •The patient had already used hypoglycemic drugs as an adjunct to insulin therapy before admission;
- •DKA、 Serious infection, perioperative status, severe trauma, pregnancy, patient's past or current involvement in interventional clinical research；
- •The standard for determining stress hyperglycemia by the supervising physician;
- •Patients who have no medication records or have not followed the treatment plan formulated by the doctor.
研究组 & 干预措施
GLD+insulin group
Patients with insulin and additional glucose-lowering drugs to treat type 1 diabetes were identified as adjuvant medication users (GLD+insulin group).
干预措施: GLD+insulin group (Drug)
insulin-only group
Patients who did not use glucose-lowering drugs (GLDs) as an adjunct to treat type 1 diabetes in the datasets were identified as insulin-only users (insulin-only group)
结局指标
主要结局
HbA1c
时间窗: Baseline to 3 months, 6 months, 12 months
The primary outcome measure is glycated hemoglobin (HbA1c), which reflects the average blood glucose level of Chinese patients with type 1 diabetes mellitus (T1DM) over the past 2-3 months. HbA1c levels will be measured using a standardized clinical detection method at the baseline and follow-up visits of the study, to evaluate the long-term blood glucose control effect of insulin plus GLDs combined therapy compared with insulin monotherapy in real-world practice.
次要结局
- Absolute and relative insulin doses(Baseline to 3 months, 6 months, 12 months)
研究者
Chenyang Shi
Ph D
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine