| Parametera . | Per protocol (N = 102) . | Expanded (N = 171) . | Safety (N = 232) . | ||
|---|---|---|---|---|---|
| Severe hypoglycemia (SH) events, total (definite/probable/possible) | 6 (1/4/1) | 7 (1/4/2) | 15 (4/8/3) | ||
| Using system/not using system | 6/0 | 7/0 | 13/2 | ||
| Self-reported hospitalization | 0 | 0 | 2 | ||
| # of events per participant, n (%) | |||||
| 0 | 98 (96) | 166 (97) | 221 (95) | ||
| 1 | 2 (2) | 3 (2) | 7 (3) | ||
| ≥ 2 | 2 (2) | 2 (1) | 4 (2) | ||
| Incidence per 100 person-years | 6.7 | 5.2 | 9.0 | ||
| DKA events, total (definite/probable/possible) | 0 | 1 (0/1/0) | 1 (0/1/0) | ||
| Using system/not using system | 0/0 | 1/0 | 1/0 | ||
| Self-reported hospitalization | 0 | 1 | 1 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 170 (>99) | 231 (>99) | ||
| 1 | 0 (0) | 1 (<1) | 1 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0.7 | 0.6 | ||
| Hyperglycemia events (treated at healthcare facility), total | 0 | 0 | 2 | ||
| Using system/not using system | 0/0 | 0/0 | 0/2 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 171 (100) | 230 (>99) | ||
| 1 | 0 (0) | 0 (0) | 2 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0 | 1.2 | ||
| CGM events (treated at healthcare facility), total | 0 | 0 | 0 | ||
| Hospitalizations (reasons other than SH and DKA), totalb | 13 | 24 | 28 | ||
| Using system/not using system | 21/1 | 21/3 | 24/4 | ||
| # of events per participant, n (%) | |||||
| 0 | 92 (90) | 155 (91) | 212 (91) | ||
| 1 | 7 (7) | 10 (6) | 14 (6) | ||
| ≥ 2 | 3 (3) | 6 (3) | 6 (3) | ||
| Incidence per 100 person-years | 14.5 | 17.7 | 16.8 | ||
| Parametera . | Per protocol (N = 102) . | Expanded (N = 171) . | Safety (N = 232) . | ||
|---|---|---|---|---|---|
| Severe hypoglycemia (SH) events, total (definite/probable/possible) | 6 (1/4/1) | 7 (1/4/2) | 15 (4/8/3) | ||
| Using system/not using system | 6/0 | 7/0 | 13/2 | ||
| Self-reported hospitalization | 0 | 0 | 2 | ||
| # of events per participant, n (%) | |||||
| 0 | 98 (96) | 166 (97) | 221 (95) | ||
| 1 | 2 (2) | 3 (2) | 7 (3) | ||
| ≥ 2 | 2 (2) | 2 (1) | 4 (2) | ||
| Incidence per 100 person-years | 6.7 | 5.2 | 9.0 | ||
| DKA events, total (definite/probable/possible) | 0 | 1 (0/1/0) | 1 (0/1/0) | ||
| Using system/not using system | 0/0 | 1/0 | 1/0 | ||
| Self-reported hospitalization | 0 | 1 | 1 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 170 (>99) | 231 (>99) | ||
| 1 | 0 (0) | 1 (<1) | 1 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0.7 | 0.6 | ||
| Hyperglycemia events (treated at healthcare facility), total | 0 | 0 | 2 | ||
| Using system/not using system | 0/0 | 0/0 | 0/2 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 171 (100) | 230 (>99) | ||
| 1 | 0 (0) | 0 (0) | 2 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0 | 1.2 | ||
| CGM events (treated at healthcare facility), total | 0 | 0 | 0 | ||
| Hospitalizations (reasons other than SH and DKA), totalb | 13 | 24 | 28 | ||
| Using system/not using system | 21/1 | 21/3 | 24/4 | ||
| # of events per participant, n (%) | |||||
| 0 | 92 (90) | 155 (91) | 212 (91) | ||
| 1 | 7 (7) | 10 (6) | 14 (6) | ||
| ≥ 2 | 3 (3) | 6 (3) | 6 (3) | ||
| Incidence per 100 person-years | 14.5 | 17.7 | 16.8 | ||
Abbreviations: CGM, continuous glucose monitoring; DKA diabetic ketoacidosis; SH, severe hypoglycemia.
aThe medical monitor determined that no events were related to Bigfoot Unity; 39 participants (4 per protocol, 10 expanded, 39 safety) never completed a safety survey.
bThree (3) deaths were reported during follow-up and classified as other hospitalizations. Two (2) participants who died were excluded from analysis in the expanded cohort and 1 was included in the expanded cohort but not the per protocol cohort. Two of three (2/3) deaths occurred while the participant was using Bigfoot Unity. The medical monitor determined that all deaths were unrelated to the System. Following the data freeze, the study team was notified of 1 additional participant death which occurred prior to the freeze. This event occurred in a T2D participant who was included in the expanded cohort but not the per protocol cohort and is not tabulated in other hospitalizations.
| Parametera . | Per protocol (N = 102) . | Expanded (N = 171) . | Safety (N = 232) . | ||
|---|---|---|---|---|---|
| Severe hypoglycemia (SH) events, total (definite/probable/possible) | 6 (1/4/1) | 7 (1/4/2) | 15 (4/8/3) | ||
| Using system/not using system | 6/0 | 7/0 | 13/2 | ||
| Self-reported hospitalization | 0 | 0 | 2 | ||
| # of events per participant, n (%) | |||||
| 0 | 98 (96) | 166 (97) | 221 (95) | ||
| 1 | 2 (2) | 3 (2) | 7 (3) | ||
| ≥ 2 | 2 (2) | 2 (1) | 4 (2) | ||
| Incidence per 100 person-years | 6.7 | 5.2 | 9.0 | ||
| DKA events, total (definite/probable/possible) | 0 | 1 (0/1/0) | 1 (0/1/0) | ||
| Using system/not using system | 0/0 | 1/0 | 1/0 | ||
| Self-reported hospitalization | 0 | 1 | 1 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 170 (>99) | 231 (>99) | ||
| 1 | 0 (0) | 1 (<1) | 1 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0.7 | 0.6 | ||
| Hyperglycemia events (treated at healthcare facility), total | 0 | 0 | 2 | ||
| Using system/not using system | 0/0 | 0/0 | 0/2 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 171 (100) | 230 (>99) | ||
| 1 | 0 (0) | 0 (0) | 2 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0 | 1.2 | ||
| CGM events (treated at healthcare facility), total | 0 | 0 | 0 | ||
| Hospitalizations (reasons other than SH and DKA), totalb | 13 | 24 | 28 | ||
| Using system/not using system | 21/1 | 21/3 | 24/4 | ||
| # of events per participant, n (%) | |||||
| 0 | 92 (90) | 155 (91) | 212 (91) | ||
| 1 | 7 (7) | 10 (6) | 14 (6) | ||
| ≥ 2 | 3 (3) | 6 (3) | 6 (3) | ||
| Incidence per 100 person-years | 14.5 | 17.7 | 16.8 | ||
| Parametera . | Per protocol (N = 102) . | Expanded (N = 171) . | Safety (N = 232) . | ||
|---|---|---|---|---|---|
| Severe hypoglycemia (SH) events, total (definite/probable/possible) | 6 (1/4/1) | 7 (1/4/2) | 15 (4/8/3) | ||
| Using system/not using system | 6/0 | 7/0 | 13/2 | ||
| Self-reported hospitalization | 0 | 0 | 2 | ||
| # of events per participant, n (%) | |||||
| 0 | 98 (96) | 166 (97) | 221 (95) | ||
| 1 | 2 (2) | 3 (2) | 7 (3) | ||
| ≥ 2 | 2 (2) | 2 (1) | 4 (2) | ||
| Incidence per 100 person-years | 6.7 | 5.2 | 9.0 | ||
| DKA events, total (definite/probable/possible) | 0 | 1 (0/1/0) | 1 (0/1/0) | ||
| Using system/not using system | 0/0 | 1/0 | 1/0 | ||
| Self-reported hospitalization | 0 | 1 | 1 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 170 (>99) | 231 (>99) | ||
| 1 | 0 (0) | 1 (<1) | 1 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0.7 | 0.6 | ||
| Hyperglycemia events (treated at healthcare facility), total | 0 | 0 | 2 | ||
| Using system/not using system | 0/0 | 0/0 | 0/2 | ||
| # of events per participant, n (%) | |||||
| 0 | 102 (100) | 171 (100) | 230 (>99) | ||
| 1 | 0 (0) | 0 (0) | 2 (<1) | ||
| ≥ 2 | 0 (0) | 0 (0) | 0 (0) | ||
| Incidence per 100 person-years | 0 | 0 | 1.2 | ||
| CGM events (treated at healthcare facility), total | 0 | 0 | 0 | ||
| Hospitalizations (reasons other than SH and DKA), totalb | 13 | 24 | 28 | ||
| Using system/not using system | 21/1 | 21/3 | 24/4 | ||
| # of events per participant, n (%) | |||||
| 0 | 92 (90) | 155 (91) | 212 (91) | ||
| 1 | 7 (7) | 10 (6) | 14 (6) | ||
| ≥ 2 | 3 (3) | 6 (3) | 6 (3) | ||
| Incidence per 100 person-years | 14.5 | 17.7 | 16.8 | ||
Abbreviations: CGM, continuous glucose monitoring; DKA diabetic ketoacidosis; SH, severe hypoglycemia.
aThe medical monitor determined that no events were related to Bigfoot Unity; 39 participants (4 per protocol, 10 expanded, 39 safety) never completed a safety survey.
bThree (3) deaths were reported during follow-up and classified as other hospitalizations. Two (2) participants who died were excluded from analysis in the expanded cohort and 1 was included in the expanded cohort but not the per protocol cohort. Two of three (2/3) deaths occurred while the participant was using Bigfoot Unity. The medical monitor determined that all deaths were unrelated to the System. Following the data freeze, the study team was notified of 1 additional participant death which occurred prior to the freeze. This event occurred in a T2D participant who was included in the expanded cohort but not the per protocol cohort and is not tabulated in other hospitalizations.
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