Title: Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes(ID3957)
Funder: Department of Health and Social Care

Abstract: Type 1 Diabetes is a life-long condition where the individual’s pancreas significantly reduces \ stops producing the hormone insulin that manages blood glucose levels. As a result, the individual must self-administer insulin, monitor their blood glucose levels, and take into consideration many multiple variables to achieve a tight blood glucose control range. _x000D_ _x000D_ With the challenge of self-management, blood glucose levels may swing high (hyperglycemia) and low (hypoglycemia) multiple times a day. This can result in the individual experiencing confusion, fatigue, nausea and possible unconsciousness as part of their daily management. The long-term risks of high blood glucose levels include damaging blood vessels impacting sight, sense of touch and other vital organs. The individual uses the information they have to administer the amount of insulin the body requires while limiting high and low blood sugars and control the recovery of them. The day-to-day management of the condition, and at times struggle to maintain a controlled blood glucose level, puts a significant burden on the patient and careers that can result in impact to the quality of life and a feeling that the condition limits \ controls their abilities._x000D_ _x000D_ Management of Type 1 Diabetes _x000D_ Management of Type 1 Diabetes is done via lifestyle adjustments and reviewing multiple sources of data about the individual to help calculate the amount of insulin to deliver. This commonly covers the following:_x000D_ Lifestyle_x000D_ - A balanced diet including complex carbohydrates, fats and proteins avoiding processed food slows the impact of food on blood glucose level reducing the possibility of sudden high or lows. _x000D_ - Exercise improves the body's sensitivity to insulin, therefore, reducing the amount to be injected. This can reduce the possibility of unexpected sudden blood glucose changes that a larger dose of insulin may bring, as well as general well-being in reducing stress that can cause insulin resistance. _x000D_ Data_x000D_ - Patients' understanding and monitoring their bodies reaction to insulin and foods to calculate their sensitivity to insulin and carbohydrates._x000D_ - Monitoring of blood glucose levels via “finger pricks” where the individual draws a small amount of blood to get a point in time reading or continuous glucose monitors that provide a real-time reading of blood glucose._x000D_ Insulin Delivery_x000D_ - Via daily injections or insulin pump that is connected to the body 24/7. Injections can be of rapid acting insulins that take effect within a short time frame (bolus) and long-acting insulins that release over a 12-to-24 hour period providing an amount of background insulin in the body (basal). Insulin pumps provide rapid acting insulin with the ability to deliver complex bolus quickly and easily and continuous background basal delivery that can be precisely adjusted for example every 5 minutes to form a unique 24-hour profile for the individual. _x000D_ _x000D_ Processing of this information and deciding the best action is an ongoing challenge for the individual, example of such challenges:_x000D_ - Diet: Poor diet education, cost of access to fresh food and the challenge of avoiding easily accessible cheap highly processed foods._x000D_ - Exercise: Lifestyle habits and motivation to exercise, along with the management of changes to insulin sensitivity while and after exercise._x000D_ - Insulin Delivery: The inconvenience of injections and their limited control of insulin delivery, Pumps with an overwhelming number of options for consideration._x000D_ - Blood Glucose Monitoring: Uncomfortable and limited visibility of trend provided by manual blood glucose tests, continuous glucose monitors providing an overwhelming amount of real-time data for the individual to process._x000D_ - Alarm fatigue: Frustration of alarms informing the individual of high or low blood glucose and lack of proactive information to help prevent such events. _x000D_ - Overtreatment: Miscalculation, frustration or unexpected sensitivity/resistance to Insulin that can result in multiple highs and lows within a short timeframe._x000D_ - Changes in sensitivity to insulin, food and many other factors that change over time and day to day._x000D_ _x000D_ Hybrid closed loop systems_x000D_ Hybrid closed loop systems provide a control algorithm that reviews data, along with reviewing the impact of its past actions, and actioning minor frequent adjustments of insulin delivery to managing blood glucose levels. The system is proactive versus reactive with the information that is provided and can make calculations and actions by utilising the real-time feed of data provided by a continuous glucose monitor and a high level of controlled delivery offered by an insulin pump at a frequency that is unattainable by a human being. As a result, such systems can significantly reduce the burden on the patient by supporting them with handling the volume of data and technology available in the management of their condition with intervention only when needed. _x000D_ _x000D_ The aim of the current project is to review the clinical and cost-effectiveness of hybrid closed loop systems for managing glucose in people who have T1DM and are having difficulty managing their condition.

Lay abstract: The External Assessment Group (EAG) will evaluate hybrid close loop systems in terms of their clinical and cost-effectiveness in managing Type 1 diabetes mellitus.

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: METABOLIC AND ENDOCRINE