Application of a Protocol of Personalized Medicine in Patients With Type 2 Diabetes Mellitus and Multiple Doses of Insulin in Routine Clinical Care
概览
- 阶段
- 不适用
- 干预措施
- Personalized treatment
- 疾病 / 适应症
- Type 2 Diabetes Mellitus
- 发起方
- Hospital Arnau de Vilanova
- 入组人数
- 239
- 试验地点
- 2
- 主要终点
- Percentage of patients whose prandial insulin is withdrawn
- 状态
- 已完成
- 最后更新
- 上个月
概览
简要总结
The goal of this observational study is to test a protocol of personalized medicine in routine clinical practice in people with type 2 diabetes (T2DM) treated with multiple dose insulin injections (MDI).
The main question[s] it aims to answer are:
• Are c-peptide titers and B-cell autoimmunity useful to help the decision of suspending prandial insulin in patients with T2DM treated with MDI?
Participants will:
- Wear a continuous glucose monitor for 10-14 days
- Will be asked for a C-peptide and GAD antibody test (GADA)
- Will stop prandial insulin and switch to other diabetes treatments if needed if c-peptide is > 0.7 mmol/L and/or C-peptide is > 0.3 mmol/L and GADA are negative
- Will be followed-up by their GP in routine clinical practice
- Will be assessed after 6 months (CGM, HbA1c, quality of life (QoL)
详细描述
An algorithm will be applied in which, depending on the presence/absence of pancreatic autoimmunity and the estimation of pancreatic reserve, the same treatment will be maintained and CGM (continuous glucose monitoring) will be initiated or the prandial insulin and the treatment will be adjusted following the main clinical guidelines.
研究者
Marta Hernandez Garcia
MD PhD
Hospital Arnau de Vilanova
入排标准
入选标准
- •Type 2 diabetes treated with multiple dose insulin therapy
排除标准
- •Gestation or planning gestation in the following 12 months
- •Glucocorticoid use for an acute condition
- •Transient insulinisationt (less than 6 months)
- •Any condition that prevents the patient or their caregiver from following up for 6 months
- •Severe mental illness
- •Drug or alcohol abuse
研究组 & 干预措施
MDI T2DM
Patients wit type 2 diabetes (T2DM) treated with multiple dose insulin therapy (MDI)
干预措施: Personalized treatment
结局指标
主要结局
Percentage of patients whose prandial insulin is withdrawn
时间窗: At 6 months from the inclusion
Percentage of patients whose prandial insulin is withdrawn
次要结局
- Adherence to trearment(6 months)
- Diabetes treatment satisfaction(6 months)
- Number of severe hypoglycaemia events(6 months)
- Diabetes quality of life(6 months)
- Glucose control(6 months)