HbA1c TargeT AcheIvemeNt in diabeteS. Psychometric and biomedical outcomes of HbA1c target-setting in adults with Type 1 and Type 2 diabetes: A mixed-methods parallel-group randomised feasibility study

St Helens and Knowsley Teaching Hospitals NHS Trust0 个研究点目标入组 50 人开始时间: 2021年6月11日最近更新: 2023年8月21日

适应症

试验速览

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36302049/ (added 28/10/2022) 2023 Abstract results in https://doi.org/10.1111/dme.15048 Abstracts P300, P302 and P303. Presented at the Diabetes UK Professional Conference 2023. (added 04/08/2023) 2023 Abstract results in https://doi.org/10.2337/db23-1056-P Presented at the American Diabetes Association (ADA) conference (added 04/08/2023)

•Sub-study A:
•1. Aged 18 and over.
•2. Has Type 1 or Type 2 Diabetes.
•3. HbA1c >/=64;
•Sub-study B:
•1. Enrolled in study A.
•Sub-study C:
•1. Healthcare professional directly involved in the care of people with diabetes.
•Sub-study D:
•1. Eligible patients declining entry into sub-study A will be approached for inclusion in study D.

•Sub-study A:
•1. Patients at risk of CVD events.
•2. Patients with an episode of severe hypoglycaemia with the past 12 months.
•3. Patients with hypoglycaemia unawareness (defined as a GOLD score =4).
•4. Patients unwilling to self-monitor blood glucose at home (if clinical management requires).
•5. Patients unwilling to inject insulin (if clinical management requires).
•6. BMI =45 kg/m².
•7. Patients who have opted-out from being contacted by researchers under the NHS national data opt-out service.
•8. Patients with other serious illnesses which may limit survival or factors which may limit adherence to study interventions.
•9. Patients currently participating in another clinical trial.
•10. Patients with a transplanted organ.
•11. Pregnancy.
•12. Patients with requirements for regular blood transfusion or venesection.
•13. Ongoing medical therapy known to cause difficulties with glycaemic control (e.g. corticosteroid therapy).

发起方

St Helens and Knowsley Teaching Hospitals NHS Trust