Diabetes Hypoglycemic Event


This example CRF shows data collected about the occurrence of hypoglycemic events.


Both EX and EC variables are shown. The sponsor will need to decide which exposure domain to use for the study, please see the SDTMIG for more information. Sponsors should utilize controlled terminology for the Exposure and Concomitant Medications unit fields.


Diabetes Hypoglycemic Event
Diabetes Hypoglycemia
Reported Term for the Clinical Event
Category for Clinical Event
Any hypoglycemic events experienced?Yes  No  
Sponsor Defined ID
Date of Event
01 Jan 2000
Time of Event
12:00
When did the hypoglycemic event occur?Between Bedtime and Waking  Between Waking and Bedtime  
In the opinion of the investigator, was this an adverse event?Yes  No  
Was a glucose measurement obtained at the time of the event?Yes  No  
Glucose Result
Glucose Unitsmg/dL  mmol/L  
Exposure Category
Date
01 Jan 2000
Time
12:00
Dose
Units
Diabetes Anit-Hyperglycemic Med
Category for Medication
Subcategory for Medication
Date
01 Jan 2000
Time
12:00
Dose
Units
Date
01 Jan 2000
Time
12:00
Diabetes Hypo Symptoms
Category for Clinical Event
Were signs/symptoms present? (If yes, complete the following)Yes  No  
SweatingYes  No  
Tremors/TremblingYes  No  
DizzinessYes  No  
Cognitive ImpairmentYes  No  
Loss of ConsciousnessYes  No  
Convulsions/SeizureYes  No  
ComaYes  No  
Other (Specify)Yes  No  
Specify Other
Precipitating Factors
Category for Findings About
Findings About Object of the Observation
Were any precipitating factors reported?Yes  No  
Alcohol ConsumptionYes  No  
Concurrent IllnessYes  No  
Deviation from Dosing InstructionsYes  No  
Missed, Delayed or Smaller MealYes  No  
Physical ActivityYes  No  
Other (Specify)Yes  No  
Specify Other
HYPO TREATMENT
Category for Medication
Was any treatment given for the hypoglycemic event? (If yes, complete the following)Yes  No  
DrinkYes  No  
FoodYes  No  
Glucose TabletsYes  No  
Glucose InjectionYes  No  
Intravenous GlucoseYes  No  
If treatment given, indicate if assistance was neededNone - Subject Treated Self  Subject was Capable of Treating Self, but Received Assistance  Subject was Not Capable of Treating Self, and Required Assistance  
* Mandatory field

Package(s)
Diabetes_Hypoglycemic_Event_2023_06_27.zip