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 Units mg/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  
Sweating Yes  No  
Tremors/Trembling Yes  No  
Dizziness Yes  No  
Cognitive Impairment Yes  No  
Loss of Consciousness Yes  No  
Convulsions/Seizure Yes  No  
Coma Yes  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 Consumption Yes  No  
Concurrent Illness Yes  No  
Deviation from Dosing Instructions Yes  No  
Missed, Delayed or Smaller Meal Yes  No  
Physical Activity Yes  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  
Drink Yes  No  
Food Yes  No  
Glucose Tablets Yes  No  
Glucose Injection Yes  No  
Intravenous Glucose Yes  No  
If treatment given, indicate if assistance was needed None - 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