Diabetes Mellitus, Type 1, Progression
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Royal Devon and Exeter NHS Foundation Trust
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| C-peptide value at a year | 12 months | 12 month (Mixed Meal Tolerance Test) MMTT area under the curve (AUC) C-peptide. |
| Change in C-peptide over a year | 12 months | Rate of change of MMTT AUC C-peptide over 12 months assessed at regular study visits |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| C-peptide value at 12 months | 12 months | Mean C-peptide at 12 months assessed using MMTT and home blood samples |
| Glucose variability & hypoglycemia | 12 months | Glucose variability & hypoglycemia as measured by continuous glucose monitoring (CGM) |
| Change in dried blood spot C-peptide | 12 months | Rate of change in home dried blood spot C-peptide over 12 months |
Countries
United Kingdom
Outcome results
None listed