Randomized Outpatient Trial of Single- and Dual-Hormone Closed-Loop Systems That Adapt to Exercise Using Wearable Sensors

Abstract

The addition of glucagon delivery to a closed-loop system with automated exercise detection reduces hypoglycemia in physically active adults with type 1 diabetes.

The Bio-inspired Artificial Pancreas for Type 1 Diabetes Control in the Home: System Architecture and Preliminary Results

“…The Tandem t:slim insulin pump modified for AP clinical trials has a known issue arising from the Bluetooth chip which randomly disconnects and does not reconnect unless the Bluetooth on the pump is toggled off and on. This was also seen by other groups using this pump [42,43]. The percentage time in closed-loop mode was comparable to the one achieved in other clinical trials [43].…”

ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes technologies

“…Use of automated insulin delivery systems have been shown to reduce nocturnal hypoglycemia following physical activity occurring in the afternoon and increase TIR as compared to open‐loop therapy . Yet, the ability to mitigate hypoglycemia during exercise has remained elusive leading to the development of different system announcements, incorporation of heart rate data, dual hormone approaches, and intake of carbohydrates being applied to overcome this obstacle …”

“…222,249 Yet, the ability to mitigate hypoglycemia during exercise has remained elusive leading to the development of different system announcements, incorporation of heart rate data, dual hormone approaches, and intake of carbohydrates being applied to overcome this obstacle. 214,[250][251][252][253] High user acceptability and improved measures of treatment satisfaction have been shown. [254][255][256][257] However, it should be noted that device alerts and alarms and technical difficulties can negatively affect the overall experience using automated insulin delivery.…”

Low doses of dasiglucagon consistently increase plasma glucose levels from hypoglycaemia and euglycaemia in people with type 1 diabetes mellitus

“…One option for further improvement might be dual‐hormone artificial pancreas (DHAP) systems which, in addition to insulin, use glucagon to counteract the effect of excessive insulin . The administration of mini‐doses of glucagon in a DHAP system has been shown to be more effective in preventing hypoglycaemia than the suspension of insulin delivery alone, particularly in situations of rapidly decreasing glucose levels, such as late postprandial hypoglycaemia or physical activity . As currently available glucagon formulations show limited stability, daily glucagon renewal is required, making the use of DHAP systems cumbersome .…”

“…delivery alone, particularly in situations of rapidly decreasing glucose levels, such as late postprandial hypoglycaemia or physical activity. [4][5][6][7][8][9] As currently available glucagon formulations show limited stability, daily glucagon renewal is required, making the use of DHAP systems cumbersome. [10][11][12] Because of this practical limitation, mainly shortterm efficacy and safety have been demonstrated to date.…”