Study: NCT04023487

Adverse event: Inpatient Hospitalization: not study related; not hyperglycemia; not hypglycemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: vomiting with blood in it (n=1), or abdominal pain (n=1), or appendicitis (n=1)
Frequency: 2 affected / 104 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Psychiatric disorders
Notes: mental health issues (further details not known) (n=2)
Frequency: 1 affected / 104 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Nervous system disorders
Notes: seizures (n=1), or MRI for unknown reason (n=1)
Frequency: 2 affected / 104 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Cardiac disorders
Notes: heart surgery (unrelated to diabetes)
Frequency: 1 affected / 104 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: General disorders
Notes: "stress-related diabetes issue"
Frequency: 1 affected / 104 at risk

Adverse event: Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 104 at risk

Adverse event: Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 104 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 104 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: Endocrine disorders
Frequency: 4 affected / 104 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: vomiting due to medication (unrelated to diabetes) (n=1), or "stomach issues" (unrelated to diabetes) (n=1), or appendix or gallbladder issue (unrelated to diabetes) (n=1), or food poisoning/dehydration (n=1), or "gastro" (n=1)
Frequency: 2 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: General disorders
Notes: swollen foot, retinopathy, chest pain, cocaine overdose/heart problems, diabetic neuropathy, Crohn's disease, car or motorcycle accident, abdominal pain, hand foot and mouth disease, fainting after COVID-19 vaccine, or unknown reason
Frequency: 3 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: General disorders
Notes: diabetes-related gastroparesis (n=1), or blood clot + urinary tract infection + pancreatitis + gallstones (n=1), or respiratory issues requiring nebulizer (n=1)
Frequency: 3 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Infections and infestations
Notes: eye infection (n=1), or kidney infection (unrelated to diabetes) (n=1), or kidney infection (related to diabetes (n=1), or mastitis (n=1), or COVID-19 (n=3), or respiratory syncytial virus (n=1)
Frequency: 5 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Infections and infestations
Notes: abscess (n=2), or COVID-19 (n=1)
Frequency: 3 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: unknown infection (unrelated to diabetes) (n=1), or food poisoning (n=2)
Frequency: 3 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: food poisoning
Frequency: 1 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: broken patella (n=1), or broken arm (n=1), or broken wrist from horseback riding accident (n=1)
Frequency: 1 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: broken arm
Frequency: 1 affected / 104 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Product Issues
Notes: "sensor copper wire lost in stomach" (not from any study-related CGM)
Frequency: 1 affected / 104 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Endocrine disorders
Notes: low blood sugar levels
Frequency: 1 affected / 104 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: food poisoning/dehydration
Frequency: 1 affected / 104 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Infections and infestations
Notes: cyst/mass (n=1), or walking pneumonia (n=1)
Frequency: 2 affected / 104 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: finger injury for shopping cart (n=1), or ankle injury from skateboarding (n=1), or elbow injury/inflammation (n=1)
Frequency: 3 affected / 104 at risk

Adverse event: Physical symptom (not serious, Study-related)
Serious: no
Organ System: Product Issues
Notes: Skin reaction/irritation from study CGM or adhesive tape used to apply study CGM
Frequency: 1 affected / 104 at risk

Adverse event: Inpatient Hospitalization: not study related; not hyperglycemia; not hypglycemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: vomiting with blood in it (n=1), or abdominal pain (n=1), or appendicitis (n=1)
Frequency: 1 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: General disorders
Notes: orthostatic hypotension (n=1), or diabetic foot ulcer (n=1), or urinary tract infection + blood clot (n=1), or unknown reason (n=2),
Frequency: 4 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Infections and infestations
Notes: "stomach infection" unrelated to diabetes (n=1), or COVID-19 (n=1), or unknown infection (n=1)
Frequency: 3 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: ankle fracture
Frequency: 1 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Psychiatric disorders
Notes: mental health issues (further details not known) (n=2)
Frequency: 1 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: gynecological surgery
Frequency: 1 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Vascular disorders
Notes: stroke
Frequency: 1 affected / 105 at risk

Adverse event: Inpatient Hospitalization: not study related, not hyperglycemia, not hypoglycemia
Serious: yes
Organ System: Gastrointestinal disorders
Notes: appendectomy
Frequency: 1 affected / 105 at risk

Adverse event: Severe hypoglycemia (not study-related) -> seizure, loss of consciousness, or emergency transport
Serious: yes
Organ System: Endocrine disorders
Frequency: 7 affected / 105 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: Endocrine disorders
Frequency: 8 affected / 105 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 105 at risk

Adverse event: Severe hyperglycemia or diabetic ketoacidosis (not study-related)
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Endocrine disorders
Notes: unknown diabetes-related issue (n=1), or loss of consciousness (diabetes-related) (n=1)
Frequency: 2 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Gastrointestinal disorders
Notes: vomiting due to medication (unrelated to diabetes) (n=1), or "stomach issues" (unrelated to diabetes) (n=1), or appendix or gallbladder issue (unrelated to diabetes) (n=1), or food poisoning/dehydration (n=1), or "gastro" (n=1)
Frequency: 3 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: General disorders
Notes: swollen foot, retinopathy, chest pain, cocaine overdose/heart problems, diabetic neuropathy, Crohn's disease, car or motorcycle accident, abdominal pain, hand foot and mouth disease, fainting after COVID-19 vaccine, or unknown reason
Frequency: 10 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Immune system disorders
Notes: anaphylactic reaction (n=1), or allergic reaction (n=1)
Frequency: 2 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Infections and infestations
Notes: eye infection (n=1), or kidney infection (unrelated to diabetes) (n=1), or kidney infection (related to diabetes (n=1), or mastitis (n=1), or COVID-19 (n=3), or respiratory syncytial virus (n=1)
Frequency: 2 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: broken patella (n=1), or broken arm (n=1), or broken wrist from horseback riding accident (n=1)
Frequency: 2 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Nervous system disorders
Notes: concussion (unrelated to diabetes) (n=1)
Frequency: 1 affected / 105 at risk

Adverse event: Important medical event based upon appropriate medical judgment (not study-related)
Serious: yes
Organ System: Surgical and medical procedures
Notes: issues with picc line (unrelated to diabetes)
Frequency: 1 affected / 105 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: General disorders
Notes: acid reflux, related to diabetes
Frequency: 1 affected / 105 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Infections and infestations
Notes: stomach flu (n=1), or flu/cold symptoms (n=1)
Frequency: 2 affected / 105 at risk

Adverse event: Physical symptom (not serious, not study-related)
Serious: no
Organ System: Endocrine disorders
Notes: hypoglycemia (though no loss of consciousness or seizure)
Frequency: 1 affected / 105 at risk

Adverse event: Physical symptom (not serious, Study-related)
Serious: no
Organ System: Product Issues
Notes: Skin reaction/irritation from study CGM or adhesive tape used to apply study CGM
Frequency: 2 affected / 105 at risk

Adverse event: Psychological symptom (not serious, not study-related)
Serious: no
Organ System: Psychiatric disorders
Notes: stress
Frequency: 1 affected / 105 at risk

Adverse event: Psychological symptom (not serious, Study-related)
Serious: no
Organ System: Psychiatric disorders
Notes: Participant reported that they disliked/disagreed with several questions on study questionnaires, especially questions about food because they have an eating disorder.
Frequency: 1 affected / 105 at risk