Liz Davis; Tim Jones; Mary Abraham
Study Staff: Jennifer Nicholas; Nirubasini Paramalingam; Adam Retterath; Julie Dart;
We are testing a feature of the new MiniMed 640G insulin pump, which when used together with a real-time continuous glucose sensor can suspend and resume insulin delivery. The system has a formula in its software which uses the previous sensor readings to predict future sensor reading to determine if it should suspend insulin delivery in order to prevent hypoglycaemia or low blood glucose levels.
The aim of this study is to see how this function reduces the time spent in hypoglycaemia. We want to see if the system can prevent participants from becoming hypoglycaemic by suspending and resuming insulin delivery, without them being aware of their changing blood glucose levels. We will also be asking the participants if they think the system is useful in managing their diabetes.
Participants will be asked to wear the Minimed TM 640G insulin pump, a sensor and transmitter for the duration of the study. The sensor will communicate with the study pump so that the pump can establish if insulin delivery needs to be suspended to prevent hypoglycaemia (hypo) and to be resumed when it is safe to do so.
This study will go for 6 months and 3 weeks and will involve 5 visits. Over the first two visits participants will be taught how to use the pump and sensor, they will then commence a two week training period. This training period is used to familiarise the participants with the features of the pump and the use of the sensors.
At the third visit participants will be randomised to 6 months of intervention, or 6 months of control. Those in the intervention group will wear the pump with the predictive suspend feature turned on. People in the control group will wear the pump with the predictive suspend feature turned off. During this time, participants in both groups will be asked to test their blood glucose levels (BGL) regularly and when the pump hypoglycaemia alarm is triggered. Participants will also be required to test their ketones regularly to ensure the suspend feature is not increasing blood ketones. In both groups, the pump data will be uploaded regularly by the participants and reviewed by the study team.
In order to determine if participants think the PLGM system is useful in their diabetes management, they will be asked to complete questionnaires at the beginning and end of the study.
Pump and sensor data will be analysed to determine if the PLGM system can prevent or reduce the amount of time participants spend hypoglycaemic by suspending insulin delivery.
Funder: JDRF