Table 2.
Data item | Details |
EDTA stored blood | Translational blood samples taken at baseline, 6, 12, 18 and 24 months stored to GCP standards |
Serum stored blood | Translational blood samples taken at baseline, 6, 12, 18 and 24 months stored to GCP standards |
HbA1c measurements | HbA1c measurements from diagnosis, baseline, 6, 12, 18 and 24 months |
Demographics | Details including ethnicity, smoking, and alcohol status |
Anthropometric data | Height, weight, waist and hip measurements taken at baseline, 6, 12, 18 and 24 months |
Biochemistry and symptomology of diabetes onset | Details regarding symptoms at the time of diabetes diagnosis and prior biochemical (HbA1c) data pre-diagnosis (left-window) |
Symptomology relevant to pancreatic cancer | Detailed information regarding symptoms typical of onset of pancreatic cancer, and changes from baseline at 6, 12, 18 and 24 months |
DSMQ | The diabetes self-management questionnaire. A validated instrument assessing self-care behaviours associated with diabetes control. Measured at baseline, 6, 12, 18 and 24 months |
EQ-5D-5L | Standardised measure of health-related quality of life measured at baseline, 6, 12, 18 and 24 months |
Medical and surgical history | Changes to medical and surgical diagnoses at baseline, 6, 12, 18 and 24 months |
Medication history | Changes to prescribed medication, including for diabetes, at baseline, 6, 12, 18 and 24 months |
Pancreatic malignancy data | Data from subsequent pancreatic cancer diagnoses, including surgical and oncological therapy. |
DSMQ, Diabetes Self-Management Questionnaire; EQ-5D-5L, EuroQol Research Foundation Quality of Life Questionnaire; GCP, good clinical practice; HbA1c, glycated haemoglobin.