Real Time Continuous Glucose Monitoring and Everyday Diabetes Care

Real time continuous glucose monitoring (RT CGM) provides an estimate of blood glucose levels every 5 minutes. This value is sent to the receiver and/or a smart phone and displays glucose values continuously. The system used in this study has an added feature which allows transmission of the glucose values via Bluetooth to a mobile device. In this study we investigate the effect of the RT CGM with the ability to remotely monitor blood sugar levels on the everyday management of the diabetes of the participants and his caregiver/family. The study will follow a randomised crossover design, all participants will complete both arms, intervention and control. There is no washout period. Intervention: Participants and their caregivers will use the RT CGM system in addition to their standard of care insulin therapy in a free living setting. They will be instructed on how to use continuous glucose monitoring including sensor insertion every week and sensor care; according to the user manual. A copy of the user manual will be given to them to take home. They will be instructed to keep a record of moderate and severe hypoglycaemia and use the same glucometer throughout the study period. The study doctor/study nurse will be in contact with participants to ensure the need for any additional support and troubleshooting. Sensor data are stored on the transmitter/receiver. During the intervention arm, participants and their caregivers are asked to upload their sensor data to the computer fortnightly. After uploading, the data are accessible for the study team and if gaps are identified participants will be contacted to identify potential problems. Participant compliance and standard therapy will be monitored in their usual diabetes outpatient clinic. Timeline: Participants and their caregivers will visit the research facility four times over a period of 7 months. Following baseline assessments where participants and their parents are asked to complete questionnaires regarding psychosocial factors and quality of life, they will start a 2 week run-in period to familiarise themselves with the RT CGM system. After the run-in period, they will be randomised to either the intervention or control arm for 3 months or vice versa. At the end of the 3 months participants will immediately cross over to the other arm. After completing each arm participants and their parents will be asked to complete questionnaires regarding psychosocial factors and quality of life again.