StartRight: Getting the Right Classification and Treatment From Diagnosis in Adults With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,815
- 试验地点
- 1
- 主要终点
- Diabetes type defined by insulin requirement at 3 years
研究概览
简要总结
This study aims to achieve more accurate early classification of diabetes and identification of which patients will rapidly require insulin treatment. The investigators will recruit 1200 participants who have been diagnosed with diabetes in the last year and were aged between 18 and 50 years at the time of diagnosis. The investigators will recruit an additional cohort of 800 participants diagnosed after age 50. The investigators will record clinical features and biomarkers that may help us to determine diabetes type at diagnosis and follow participants for 3 years to assess the development of severe insulin deficiency (measured using C-peptide) and insulin requirement. The investigators will assess utility of clinical features and additional biomarkers in identifying patients with rapid progression to insulin requirement. Findings will be integrated into a freely available clinical prediction models to assist classification of diabetes at diagnosis.
详细描述
The study is a prospective observational study which will assess the relationship between clinical features and biomarkers at diabetes diagnosis and type of diabetes defined by endogenous insulin secretion at 3 years diabetes duration.
The investigators will recruit a prospective cohort of 1200 adults that have been diagnosed with diabetes within the previous 1 year and aged between 18 and 50 at the time of diagnosis. The investigators will also recruit an additional cohort of 800 participants diagnosed with diabetes in the last year aged >50 at diabetes diagnosis, who will be stratified by insulin treatment (insulin treated n=400).
On recruitment into the study, non-fasting (within 1-5 hours of a meal) blood sample will be collected for baseline analysis biomarker assessment (serum C-peptide, routine biochemistry, Islet autoantibodies (GAD, IA2, ZnT8)) and biobanking. Clinical features will be recorded, including weight, height, waist/hip ratio & blood pressure. Participants will be asked to provide a home post-meal urine sample for Urinary C-Peptide Creatinine Ratio (UCPCR). At 1 year and 2 years post recruitment, participants will be contacted by telephone, email or in person to record concurrent treatment, hypoglycaemia and health service utilisation. Participants will be asked to collect a home post-meal urine sample for Urinary C-Peptide /Creatinine Ratio (UCPCR). HbA1c results will be obtained from participants GP practice or laboratory records.
At the end of the study, 3 years post recruitment, a non-fasting blood sample will be collected for serum C-peptide, routine biochemistry and stored for future biomarker analysis. Weight change, blood pressure, concurrent treatment, hypoglycaemia and health service utilisation data will be also be recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adults diagnosed with diabetes within the previous 12 months.
- •Aged ≥18 and ≤50 at the time of diabetes diagnosis* or (additional late onset diabetes cohort) aged >50 at the time of diabetes diagnosis.
- •Able and willing to provide informed consent
排除标准
- •Gestational diabetes.
- •Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
结局指标
主要结局
Diabetes type defined by insulin requirement at 3 years
时间窗: 3 years
Type 1 diabetes = Progression to insulin treatment and severe insulin deficiency (post meal plasma C-peptide \<600pmol/L) at 3 years. Type 2 diabetes = Lack of requirement for insulin at 3 years (HbA1c \<90mmol/mol without insulin treatment or post meal C-peptide ≥ 600pmol/L if insulin treated).
次要结局
- Resilience (CD-RISC questionnaires)(3 years)
- C-peptide rate of change (UCPCR and plasma)(3 years)
- Self-reported hypoglycaemia & hypoglycaemic awareness (Modified Clark and Gold)(3 years)
- Ketoacidosis (self-reported and confirmed from medical notes)(3 years)
- Stimulated plasma C-peptide <200pmol/L at 3 years ('absolute insulin deficiency')(3 years)
- Wellbeing (SF12 questionnaire)(3 years)
- HbA1c (mean and at 3 years)(3 years)
- Weight change (baseline to 3 years)(3 years)