Study: NCT03557151

Adverse event: Inpatient Hospitalization related to diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: Two instances of the AE reported for those randomized to TC occurred prior to beginning the intervention (1 patient) or after opting out of TC and returning to Usual Care (1 patient)
Frequency: 1 affected / 37 at risk

Adverse event: Emergency Room visit related to diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: One instance of this AE occurred for a patient randomized to TC before receiving the intervention. Two additional instances of this AE occurred for a patient randomized to TC who opted to return to Usual Care prior to receiving any TC care visits
Frequency: 1 affected / 37 at risk

Adverse event: Inpatient Hospitalization unrelated to diabetes
Serious: yes
Organ System: General disorders
Notes: Instances included appendicitis and injury
Frequency: 1 affected / 37 at risk

Adverse event: Increase of 1.5% or more in HbA1c from one data point to another during study participation
Serious: no
Organ System: Endocrine disorders
Notes: Seven instances of this AE were reported among 7 TC participants prior to their receipt of the TC intervention. Two additionally instances occurred among 2 participants randomized to TC but opting to return to Usual Care prior to receiving TC
Frequency: 7 affected / 37 at risk

Adverse event: Decrease in QoL of 1.5SD or more
Serious: no
Organ System: General disorders
Notes: Two instances of this AE (drop from baseline to 6 months and drop from baseline to 12 months) were reported by 1 participant randomized to TC but who opted to return to Usual Care before receiving TC
Frequency: 8 affected / 37 at risk

Adverse event: Gap in clinical care of 6 months or more
Serious: no
Organ System: Surgical and medical procedures
Notes: All instances of this AE reported for participants randomized to TC occurred after the participant opted out of the assigned intervention
Frequency: 8 affected / 37 at risk

Adverse event: Inpatient Hospitalization related to diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: Two instances of the AE reported for those randomized to TC occurred prior to beginning the intervention (1 patient) or after opting out of TC and returning to Usual Care (1 patient)
Frequency: 3 affected / 67 at risk

Adverse event: Emergency Room visit related to diabetes
Serious: yes
Organ System: Endocrine disorders
Notes: One instance of this AE occurred for a patient randomized to TC before receiving the intervention. Two additional instances of this AE occurred for a patient randomized to TC who opted to return to Usual Care prior to receiving any TC care visits
Frequency: 6 affected / 67 at risk

Adverse event: Inpatient Hospitalization unrelated to diabetes
Serious: yes
Organ System: General disorders
Notes: Instances included appendicitis and injury
Frequency: 1 affected / 67 at risk

Adverse event: Increase of 1.5% or more in HbA1c from one data point to another during study participation
Serious: no
Organ System: Endocrine disorders
Notes: Seven instances of this AE were reported among 7 TC participants prior to their receipt of the TC intervention. Two additionally instances occurred among 2 participants randomized to TC but opting to return to Usual Care prior to receiving TC
Frequency: 19 affected / 67 at risk

Adverse event: Decrease in QoL of 1.5SD or more
Serious: no
Organ System: General disorders
Notes: Two instances of this AE (drop from baseline to 6 months and drop from baseline to 12 months) were reported by 1 participant randomized to TC but who opted to return to Usual Care before receiving TC
Frequency: 7 affected / 67 at risk

Adverse event: Gap in clinical care of 6 months or more
Serious: no
Organ System: Surgical and medical procedures
Notes: All instances of this AE reported for participants randomized to TC occurred after the participant opted out of the assigned intervention
Frequency: 5 affected / 67 at risk