SAGE-Observational study of glycaemic control & QoL in Type 1 diabetes
Research type
Research Study
Full title
Multinational, cross-sectional, observational study to describe glycemic control and quality of life for type 1 diabetic adult patients
IRAS ID
233221
Contact name
J Smith
Contact email
Sponsor organisation
Sanofi
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
SAGE is a Type 1 diabetes mellitus (T1DM), observational study (no clinical tests). The study aims to describe the percentage of patients with T1DM who have good blood glucose control (reached their target) in different age groups (26-44, 45-64 and ≥65 years old). Good blood glucose control is important for people with diabetes, as it may help to reduce the complications of diabetes, such as nerve, eye and kidney damage.
This study also aims to assess the Quality of Life in these patients using four questionnaires looking at fear of low blood glucose, emotional status, treatment satisfaction and health-related quality of life.
The following information will be found in the patient's notes or by patient interview: values for glucose control and if they have reached their target, diabetes complications and other health issues, diabetes treatments, structure and process of medical care, information about low blood glucose episodes, glucose self-monitoring methods, device used and frequency, how food intake is measured and technology usage eg, continuous glucose monitoring, insulin pump use and carbohydrate counting applications
Consecutive people with T1DM (who are eligible for the study) will be approached during their standard visit to the diabetes clinic. If they are agreeable and after the study has been explained and they have signed the consent form, they will complete the four questionnaires during the one visit. No other visits will be required.
All the information collected will be analysed and any links with good blood glucose control (patients who reached their target) will be recorded.
This study will include up to 3000 T1DM patients from 15 countries. Data will be used to identify the most important barriers to good blood glucose control and to provide caregivers and patients with information and solutions to improve the management of T1DM in adults.REC name
North of Scotland Research Ethics Committee 2
REC reference
17/NS/0098
Date of REC Opinion
2 Oct 2017
REC opinion
Further Information Favourable Opinion