Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
King's College London
With
University of Southern Denmark
Sheffield Teaching Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Ninewells Hospital
Radboud University Medical Center
Nordsjaellands Hospital
Medical University of Graz
University Hospital, Montpellier
Innovative Medicines Initiative
The Leona M. and Harry B. Helmsley Charitable Trust
Juvenile Diabetes Research Foundation
International Diabetes Federation
Novo Nordisk A/S
Abbott Diabetes Care
Medtronic MiniMed, Inc.
Age
18–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Age 18 - 85 years
2. HbA1c 5 - 10% \[31 - 86 mmol/mol\]
3. Confirmed diagnosis of type 1 or type 2 diabetes
4. Using \> 1 injection of insulin / day or insulin pump.
5. Ability to provide written informed consent
6. Performing regular SMBG \[ \> 1 / day on a 4-week download\] . For those using flash or continuous glucose monitoring, this should be used at least 70% of the time.
7. At least 1 episode of hypoglycaemia \[ either biochemical or symptomatic\] in the last month
8. On stable therapy for at least 3 months.
9. Willing to complete study procedures including wearing the Fitbit and CGM devices and completing the EMA questionnaires on the uMotif app three times a day for 10 weeks ( we expect minimum 80% data completeness)
You may not be if
1. Concurrent conditions that can affect glucose readings \[renal impairment GFR \< 30 ml/min, hepatic impairment, untreated adrenal or thyroid insufficiency, as judged by the investigator.
2. Severe cognitive impairment or psychological illness that can impair performance of EMA tasks, visual impairment that will preclude use of the EMA or sensors.
3. Severe psychiatric / psychological illness including extreme fear of hypo- or hyper- glycaemia ( in the opinion of the investigator)
4. Pregnant or plans for pregnancy in the next 6 months
5. Use of automated insulin delivery systems such as closed loop or automated threshold suspend or predictive low glucose suspend insulin pumps.
6. Known allergies to adhesives required for the CGM systems
7. People who work regular night shifts
8. Any other condition which in the opinion of the study team would impair their ability to complete the study
