ReFLeCT
Research type
Research Study
Full title
A multi-centre, prospective, non-interventional study of insulin degludec investigating the safety and effectiveness in a real world population with type 1 and 2 diabetes mellitus
IRAS ID
167769
Contact name
Michael Feher
Contact email
Sponsor organisation
Novo Nordisk
Duration of Study in the UK
1 years, 7 months, 25 days
Research summary
Hypoglycaemia is the biggest obstacle to tight glucose control and a major cause of worry and anxiety amongst patients. The development of newer basal insulin aims to introduce longer acting insulin with lower variability in blood glucose.
The REFLECT study will assess the real world safety in terms of hypoglycemia and adverse events as well as effectiveness* in terms of HbA1c and FPG level of Tresiba® in routine care, according to the label and the benefits to patients’ quality of life. These will also include the patient reported outcomes including treatment satisfaction and other aspects related to the daily life in the management of their diabetes mellitus.
This is a 12-month, multi-centre, prospective, non-interventional study assessing the safety and effectiveness of Tresiba® 100 units/mL or Tresiba® 200 units/mL OD, used with any other anti-diabetic treatment according to local label, in patients with T1DM or T2DM where the physician has decided to start the patient on Tresiba® treatment.
About 2068 patients will take part in around 220 sites within Europe
Patients with T1DM and T2DM who are treated with insulin will be followed for a minimum of 4 weeks before, and a maximum of 12 months after switching to Tresiba®. Patients will be asked to complete a study diary and questionnaires, patients records will be updated as per usual practice.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
15/NW/0055
Date of REC Opinion
2 Feb 2015
REC opinion
Further Information Favourable Opinion