Defining the Decline in Endogenous Insulin Secretion in Type 1 Diabetes Diagnosed After 30 Years of Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- C-peptide value at a year
研究概览
简要总结
The study aims is to find out if people with type 1 diabetes diagnosed in later life (after age 30) have the same rapid loss of insulin secretion (measured using C-peptide) that occurs in younger adults with type 1 diabetes. The investigators will recruit 135 participants aged over 30 years with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. The investigators will also recruit a comparison group of 61 participants aged 18-30 with a clinical diagnosis of type 1 diabetes and diabetes duration ≤100 days. C-peptide will be measured during mixed meal tolerance tests (MMTT) performed at baseline, 6 months and a year.
This study also aims to test a new more practical way of monitoring insulin secretion at home using a finger prick 'blood spot' rather than time consuming tests in a hospital. Finger-prick C-peptide samples will be collected after the MMTT and by the participants at home throughout the year.
详细描述
The study aims to evaluate progression of type 1 diabetes. Primary analysis will be conducted on those with >=1 diabetes autoantibody positive (GAD, IA2 ZNT8). Sensitivity analysis will be performed by repeating all analysis defining T1D as a) double antibody positivity and b) single antibody positivity combined with a high genetic risk score for T1D (T1DGRS>5th centile of a control population).
Further aims will be to evaluate the utility of dried blood spot testing to detect change in C-peptide and the utility of home test results as a marker of hypoglycaemia and glucose variability.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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 with a clinical diagnosis of Type 1 diabetes within the previous 100 days.
- •Aged >30 at the time of Type 1 diabetes diagnosis OR (additional early onset Type 1 diabetes cohort) aged ≥18 and ≤30 at the time of Type 1 diabetes diagnosis.
- •Insulin treated at the time of recruitment
- •Able and willing to provide informed consent.
- •Exclusion criteria
- •Pregnancy
- •Known monogenic diabetes
- •Known secondary diabetes (diabetes considered likely due to medication, cystic fibrosis, pancreatitis, pancreatic cancer, pancreatic surgery, hemochromatosis or Cushing's syndrome).
排除标准
- 未提供
结局指标
主要结局
C-peptide value at a year
时间窗: 12 months
12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide.
Change in C-peptide over a year
时间窗: 12 months
Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits
次要结局
- C-peptide value at 12 months(12 months)
- Change in dried blood spot C-peptide(12 months)
- Glucose variability & hypoglycemia(12 months)