Event Group
Event Groups are part of the Adverse Events Module within the Results Section. They provide a way to organize and summarize adverse event data by grouping related events together.
Each Event Group typically represents a category or class of adverse events and includes statistical information such as the number of participants affected and at risk for different event types: deaths, serious events, and other events.
Event Group path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Group
Event Group
Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-25 @ 4:50 PM
NCT ID:
NCT01418703
Group ID:
EG001
Title:
sCTR Closed-Loop Control
Description:
The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
Deaths Number Affected:
None
Deaths Number At Risk:
None
Serious Number Affected:
0
Serious Number At Risk:
26
Other Number Affected:
2
Other Number At Risk:
26
Study:
NCT01418703
Results Section:
NCT01418703
Adverse Events Module:
NCT01418703