On occasion, users will contact customer support with a problem they consider to be a technical issue but which is actually a clinical issue.
1.1 Glucose high despite insulin shown being delivered
This is likely to be due to a full or partial set failure / air in the line. The user should check for ketones, change cannula and perform a full set change. If blood ketones are present they should turn off the Automode, follow usual pump sick day rules and contact their clinical team for further advice as needed.
NOTE: Incidents of Diabetic Ketoacidosis (DKA) requiring hospital admission should be reported immediately to Level2 customer support for investigation. Please ask the user to submit logs.
1.2 Issues relating to glucose running above or below target range
a) The user reports: “The System not giving enough insulin”, “ The algorithm is not working” , “Glucose above target”
Explanation: The algorithm has safety rules which limit insulin delivery based on total daily dose and previous learning. It will learn and adapt over time.
A clinical review will be helpful to support the user to optimise their carb:insulin ratios and personal glucose target.
b) The user reports “Algorithm working differently” following an app update or log out.
Explanation: The algorithm itself does not change between the updates. App updates are only related to security improvements or improvements to the functionality or the user interface, e.g. addition of PDF reports.
c) User reports the app is “not working as well” following a log out or uninstall re-install.
Explanation: Learning is linked to the login / username and this is saved to the CamDiab Cloud every midnight.
Learning is not lost if you need to change devices or reinstall the app BUT an accurate weight and correct Total Daily
Dose must be entered. If these are significantly different to those the system is expecting, the user will receive a
message “ learning has not been restored”.
d) User reports the “System not delivering more insulin even though boost is programmed.”
Explanation: This is because the total active insulin (bolus and algorithm driven) has exceeded the system’s safety limit. These limits adjust over time but are based on total daily dose and time of day/previous learning experience.
e) User reports the “System under delivering” in the first few days of use. Glucose not being kept in target.
Explanation: The system is initialised with Weight and Total Daily Dose (TDD) only. If these values were not accurately calculated, it will impact the algorithm performance in the first few days, although it will learn over time. If the TDD has been vastly over or under estimated it would be worth reinitialising the app with the correct value.
f) User reports “my control has deteriorated over the past few days”
Explanation: There will always be good and bad days. A variety of factors could be responsible for transient issues, e.g. cannula problems, diet / meal absorption, lifestyle, change in activity or illness.
Consider clinical review to utilising boost, tighten the glucose targets and review carb ratios.
g) The user reports “Glucose goes high when closed loop is not running”.
Explanation: When in open loop, the system reverts to the preset pump basal settings. It is important to ensure the level of basal insulin is adequate to avoid the glucose level rising. Pre-set basal levels should be reviewed and, if required, updated 3 monthly in children and 6 to 12 monthly in adults.
1.3 Issues relating to management of young children
a) Users report “my child’s time in target range is below what we expected”.
Explanation. Expectations are important. Young children have the highest glucose variability due to a number of factors including unpredictability of food intake and activity. Suggest a review with their clinical team with specific focus on outcomes compared to pre closed loop use and need for further optimisation of carb:insulin ratios and personal glucose target.
b) Users report “The algorithm gives insulin when my child is low”
Explanation: The system pulses 0.04 of a unit of insulin every 90 minutes. This “Patency pulse” keeps the line patent to reduce the risk of occlusions. It is very unlikely that this pulse would be the cause of hypoglycaemia.
Total daily dose should be reviewed. The system is licenced for use in those requiring a TDD of 5 units or more. Please refer them to their clinical team for review if they have lower requirements.
1.4 Issues relating to hypoglycaemia
Users report higher than expected levels of hypoglycaemia
Explanation: The system prioritises avoidance of hypoglycaemia. Any one reporting such issues should be referred for clinical review where the personal glucose target, carb: insulin ratios and strategy for exercise/activity can all be reviewed.
NOTE: Incidents of severe hypoglycaemia requiring attendance of paramedics or admission to hospital should be reported immediately to level 2 customer support for investigation. Please ask the user to submit logs.
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