Trial Outcomes & Findings for The Insulin-Only Bionic Pancreas Pivotal Trial (NCT NCT04200313)

NCT ID: NCT04200313

Last Updated: 2025-02-20

Results Overview

The primary outcome is superiority for central lab hemoglobin A1c at 13 weeks. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 440 participants
• Primary outcome timeframe: 13 weeks
• Results posted on: 2025-02-20

Participant Flow

Participant milestones

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months	Bionic Pancreas iLet With Inputted Blood Glucose Measurements Run-In (BG Run) Upon completion of the RCT period, participants from the Bionic Pancreas iLet with Aspart/Lispro Insulin (BP-A/L) and Bionic Pancreas iLet with Fiasp Insulin (BP-F) groups voluntarily enrolled into the ancillary study testing iLet with inputted blood glucose measurements instead of CGM values for approximately 48 hours.	Transition to Usual Care With Bionic Pancreas iLet Guidance (BP) Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP system.	Transition to Usual Care Without Bionic Pancreas iLet Guidance (UC) Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on insulin regiments prior to enrolling in the RCT period.	Usual Care Crossover to Bionic Pancreas iLet Extension (BPX) Upon completion of the RCT period for the Usual Care (UC) arm, select participants crossed over into the 3-month extension phase using the Bionic Pancreas with either Fiasp insulin or aspart/lispro insulin.
RCT STARTED	219	114	107	0	0	0	0
RCT COMPLETED	216	113	107	0	0	0	0
RCT NOT COMPLETED	3	1	0	0	0	0	0
BG Run Ancillary Study STARTED	0	0	0	58	0	0	0
BG Run Ancillary Study COMPLETED	0	0	0	54	0	0	0
BG Run Ancillary Study NOT COMPLETED	0	0	0	4	0	0	0
Transition Phase STARTED	0	0	0	0	148	149	0
Transition Phase COMPLETED	0	0	0	0	148	147	0
Transition Phase NOT COMPLETED	0	0	0	0	0	2	0
Extension Phase STARTED	0	0	0	0	0	0	90
Extension Phase COMPLETED	0	0	0	0	0	0	84
Extension Phase NOT COMPLETED	0	0	0	0	0	0	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Insulin-Only Bionic Pancreas Pivotal Trial

Baseline characteristics by cohort

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months	Total n=440 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 19 • n=5 Participants	42 years STANDARD_DEVIATION 16 • n=7 Participants	28 years STANDARD_DEVIATION 20 • n=5 Participants	32 years STANDARD_DEVIATION 19 • n=4 Participants
Age, Customized Age · <18 years	112 Participants n=5 Participants	0 Participants n=7 Participants	53 Participants n=5 Participants	165 Participants n=4 Participants
Age, Customized Age · ≥18 years	107 Participants n=5 Participants	114 Participants n=7 Participants	54 Participants n=5 Participants	275 Participants n=4 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	62 Participants n=7 Participants	41 Participants n=5 Participants	210 Participants n=4 Participants
Sex: Female, Male Male	112 Participants n=5 Participants	52 Participants n=7 Participants	66 Participants n=5 Participants	230 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · White Non-Hispanic	157 Participants n=5 Participants	98 Participants n=7 Participants	83 Participants n=5 Participants	338 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Black Non-Hispanic	27 Participants n=5 Participants	10 Participants n=7 Participants	5 Participants n=5 Participants	42 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Hispanic or Latino	23 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants	40 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · American Indian/Alaskan Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · More than one race	7 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race/Ethnicity, Customized Race/Ethnicity Group · Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Region of Enrollment United States	219 participants n=5 Participants	114 participants n=7 Participants	107 participants n=5 Participants	440 participants n=4 Participants
HbA1c	7.9 % STANDARD_DEVIATION 1.2 • n=5 Participants	7.8 % STANDARD_DEVIATION 1.2 • n=7 Participants	7.7 % STANDARD_DEVIATION 1.1 • n=5 Participants	7.8 % STANDARD_DEVIATION 1.2 • n=4 Participants

PRIMARY outcome

Timeframe: 13 weeks

The primary outcome is superiority for central lab hemoglobin A1c at 13 weeks. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
HbA1c	56 mmol/mol Standard Deviation 7.7	54 mmol/mol Standard Deviation 6.6	61 mmol/mol Standard Deviation 10.9

SECONDARY outcome

Timeframe: 13 weeks

The key secondary endpoint is CGM-measured time <54 mg/dL over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Non-inferiority for CGM-measured Time <54 mg/dL (Key Secondary Endpoint)	0.33 Percentage Interval 0.16 to 0.6	0.26 Percentage Interval 0.12 to 0.48	0.24 Percentage Interval 0.13 to 0.63

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Mean Glucose Level Over 13 Weeks	164 mg/dL Standard Deviation 15	155 mg/dL Standard Deviation 11	181 mg/dL Standard Deviation 32

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Percentage Time 70-180 mg/dL Over 13 Weeks	65 Percentage Standard Deviation 9	71 Percentage Standard Deviation 8	54 Percentage Standard Deviation 17

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Percentage Time >180 mg/dL Over 13 Weeks	33 Percentage Standard Deviation 9	27 Percentage Standard Deviation 8	44 Percentage Standard Deviation 18

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Percentage Time >250 mg/dL Over 13 Weeks	8.5 Percentage Interval 5.3 to 13.2	4.8 Percentage Interval 2.7 to 7.6	14.9 Percentage Interval 6.3 to 25.3

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Glucose Standard Deviation (SD) mg/dL Over 13 Weeks	60 mg/dL Standard Deviation 11	52 mg/dL Standard Deviation 9	67 mg/dL Standard Deviation 16

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-Measured Percentage Time <70 mg/dL Over 13 Weeks	1.8 Percentage Interval 1.1 to 2.9	1.7 Percentage Interval 1.0 to 2.5	1.8 Percentage Interval 0.8 to 3.1

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-measured Percentage Time <54 mg/dL Over 13 Weeks	0.33 Percentage Interval 0.16 to 0.6	0.26 Percentage Interval 0.12 to 0.48	0.24 Percentage Interval 0.13 to 0.63

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
CGM-Measured Glucose Coefficient of Variation Over 13 Weeks	36 Percentage Standard Deviation 5	33 Percentage Standard Deviation 4	37 Percentage Standard Deviation 5

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.0% at week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c <7.0%	65 Participants	49 Participants	27 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with a) non-missing central lab HbA1c measurements at randomization and at 13 weeks, and b) an HbA1c value \>7.5% at randomization.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.0% at week 13 in participants with baseline HbA1c >7.5%. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=115 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=60 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=56 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c <7.0% in Participants With Baseline HbA1c >7.5%	15 Participants	18 Participants	2 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.5% at week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c <7.5%	128 Participants	86 Participants	40 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <8.0% at week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c <8.0%	182 Participants	105 Participants	73 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c >9.0% at week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c >9.0%	1 Participants	1 Participants	13 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >0.5% from baseline to week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c Improvement >0.5%	100 Participants	62 Participants	13 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >1.0% from baseline to week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0%	55 Participants	30 Participants	5 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c relative improvement >10% from baseline to week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c Relative Improvement >10%	72 Participants	42 Participants	5 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with non-missing central lab HbA1c measurements at randomization and at 13 weeks.

Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >1.0% from baseline to week 13 or central lab hemoglobin A1c <7.0% at week 13. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0% or HbA1c <7.0% at 13 Weeks	108 Participants	66 Participants	30 Participants

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-140 mg/dL Over 13 Weeks	39 Percentage Standard Deviation 8	43 Percentage Standard Deviation 7	33 Percentage Standard Deviation 13

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-120 mg/dL Over 13 Weeks	23 Percentage Standard Deviation 6	25 Percentage Standard Deviation 6	21 Percentage Standard Deviation 10

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <60 mg/dL Over 13 Weeks	0.7 Percentage Interval 0.4 to 1.1	0.5 Percentage Interval 0.3 to 1.0	0.6 Percentage Interval 0.3 to 1.3

SECONDARY outcome

Timeframe: 13 weeks

Area over the curve 70 mg/dL over the 13-week RCT period, measured as the mean of the differences between 70 mg/dL and CGM-measured glucose values below 70 mg/dL. For CGM-measured glucose values above 70 mg/dL, a value of 0 is used instead of the difference. For example, suppose a participant has 10 glucose readings of 78, 60, 59, 71, 80, 100, 110, 115, 120, and 118 mg/dL measured every 5 minutes. The distance between each reading below 70 mg/dL and 70 mg/dL is 0, 10, 11, 0, 0, 0, 0, 0, 0, and 0 mg/dL. The total area is 105 mg/dL*min; however, this value is then standardized by dividing by the length of time (50 min), resulting in a final CGM-measured area over the curve 70 mg/dL of 2.1 mg/dL.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Area Over the Curve 70 mg/dL Over 13 Weeks	0.18 mg/dL Interval 0.1 to 0.29	0.15 mg/dL Interval 0.08 to 0.25	0.16 mg/dL Interval 0.07 to 0.34

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured low blood glucose index (LBGI) over 13 weeks. Ranges from 0 to 38.20, with higher values indicating more low CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Low Blood Glucose Index (LBGI)	0.54 units on a scale Interval 0.38 to 0.76	0.55 units on a scale Interval 0.36 to 0.72	0.52 units on a scale Interval 0.31 to 0.88

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured hypoglycemic event (at least 15 consecutive minutes with a sensor reading <54 mg/dL) rate over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Hypoglycemic Events	0.68 Number of events per week Interval 0.26 to 1.19	0.53 Number of events per week Interval 0.24 to 1.1	0.48 Number of events per week Interval 0.22 to 1.31

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured hyperglycemic event (at least 90 minutes within a 120 minute period with a sensor reading >300 mg/dL) rate over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Hyperglycemic Events	0.9 Number of events per week Interval 0.4 to 2.0	0.4 Number of events per week Interval 0.2 to 0.8	2.1 Number of events per week Interval 0.6 to 4.2

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time >300 mg/dL Over 13 Weeks	2.4 Percentage Interval 1.2 to 4.7	1.0 Percentage Interval 0.4 to 1.9	6.0 Percentage Interval 1.6 to 11.6

SECONDARY outcome

Timeframe: 13 weeks

Area under the curve 180 mg/dL over the 13-week RCT period, measured as the mean of the differences between 180 mg/dL and CGM-measured glucose values above 180 mg/dL. For CGM-measured glucose values under 180 mg/dL, a value of 0 is used instead of the difference. For example, suppose a participant has 10 glucose readings of 100, 120, 182, 200, 250, 193, 179, 150, 140 and 118 mg/dL measured every 5 minutes. The distance between each reading above 180 mg/dL and 180 mg/dL is 0, 0, 2, 20, 70, 13, 0, 0, 0, and 0 mg/dL. The total area is 525 mg/dL*min; however, this value is then standardized by dividing by the length of time (50 min), resulting in a final CGM-measured area under the curve 180 mg/dL of 10.5 mg/dL.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Area Under the Curve 180 mg/dL Over 13 Weeks	17.2 mg/dL Interval 11.5 to 23.1	10.8 mg/dL Interval 8.1 to 15.4	26.2 mg/dL Interval 13.1 to 42.2

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured high blood glucose index (HBGI) over 13 weeks. Ranges from 0 to 57.27, with higher values indicating more high CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: High Blood Glucose Index (HBGI)	7.4 units on a scale Interval 5.9 to 9.1	5.8 units on a scale Interval 4.8 to 6.9	10.0 units on a scale Interval 6.4 to 14.3

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured mean of daily difference in mean glucose over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Mean of Daily Difference in Mean Glucose	20 mg/dL Standard Deviation 7	16 mg/dL Standard Deviation 5	30 mg/dL Standard Deviation 11

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-180 mg/dL >70% Over 13 Weeks	56 Participants	65 Participants	23 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%	159 Participants	90 Participants	55 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%	146 Participants	84 Participants	43 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <70 mg/dL <4%	194 Participants	109 Participants	86 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <54 mg/dL <1%	190 Participants	108 Participants	88 Participants

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: CGM-measured Blood Glucose Risk Index (LBGI + HBGI) over 13 weeks. Calculated as Low Blood Glucose Index (LBGI) + High Blood Glucose Index (HBGI). Ranges from 0 to 57.27, with higher values indicating more low or high CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome. LBGI and HBGI are inversely related: the presence of a high CGM-measured glucose reading removes an opportunity for a low glucose reading to exist and vice versa, therefore a maximum HBGI of 57.27 and a maximum LGBI of 38.20 cannot exist simultaneously. For instance, if a participant had glucose values of only 401 mg/dL, then the participant has no low glucose values, and therefore their HBGI = 57.27 and LBGI = 0. If a participant had only glucose values of 39 mg/dL, then the participant has no high glucose values, and therefore their HBGI = 0 and LBGI = 38.20. Consequently, the maximum blood glucose risk index is 57.27.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Blood Glucose Risk Index (LBGI + HBGI)	8.0 units on a scale Interval 6.7 to 9.7	6.3 units on a scale Interval 5.3 to 7.5	10.7 units on a scale Interval 6.9 to 14.9

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with a) at least 168 hours of CGM data at baseline and over the 13-week follow-up period, and b) non-missing central lab HbA1c measurements at randomization and week 13.

Other Secondary Efficacy Endpoint: Baseline to week 13 improvement in central lab hemoglobin A1c >0.5% without an increase in CGM-measured percentage time <54 mg/dl by >0.5% OR improvement in CGM-measured percentage time <54 mg/dl by >0.5% without an increase in central lab hemoglobin A1c by >0.5%. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=103 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Improvement in HbA1c > 0.5% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without an Increase in HbA1c by > 0.5%	104 Participants	62 Participants	15 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Other Secondary Efficacy Endpoint: Baseline to 13-week improvement in CGM-measured percentage time 70-180 mg/dL by >10% without an increase in CGM-measured percentage time <54 mg/dL by >0.5% OR improvement in CGM-measured percentage time <54 mg/dL by >0.5% without a decrease in CGM-measured percentage time 70-180 mg/dL by >10%

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Improvement in Time 70-180 mg/dl by >10% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without a Decrease in Time 70-180 mg/dl by > 10%	120 Participants	74 Participants	25 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Other Secondary Efficacy Endpoint: CGM-measured mean glucose <154 mg/dL and percentage time <54 mg/dL <1% over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Mean Glucose <154 mg/dL and Time <54 mg/dL <1%	46 Participants	51 Participants	17 Participants

SECONDARY outcome

Timeframe: 13 weeks

Population: Only including participants with at least 168 hours of CGM data at baseline and over the 13-week follow-up period.

Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL >70% and percentage time <54 mg/dL <1% over 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=218 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%	52 Participants	63 Participants	16 Participants

SECONDARY outcome

Timeframe: 13 weeks

Other Secondary Efficacy Endpoint: Total daily insulin (units/kg) from week 13 site-reported insulin data for the UC group and iLet pump device data over 13 weeks for the BP-A/L and BP-F groups.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=217 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=110 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Total Daily Insulin (Units/kg)	0.86 Insulin units per kg Standard Deviation 0.33	0.65 Insulin units per kg Standard Deviation 0.19	0.81 Insulin units per kg Standard Deviation 0.34

SECONDARY outcome

Timeframe: Weeks 1-2 and weeks 12-13

Population: iLet pump device was given to BP-A/L and BP/F groups only.

Other Secondary Efficacy Endpoint: Percentage change in the TDD of insulin over the first two-week period relative to the TDD of insulin in the last two-week period from iLet pump device data over 13 weeks for the BP-A/L and BP-F groups.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=202 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=107 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Percentage Change in the TDD of Insulin Over the First Two-week Period Relative to the TDD of Insulin in the Last Two-week Period	5 Percentage change Standard Deviation 21	6 Percentage change Standard Deviation 26	—

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=215 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=113 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Body Weight at Week 13	69 kg Standard Deviation 24	84 kg Standard Deviation 19	70 kg Standard Deviation 27

SECONDARY outcome

Timeframe: 13 weeks

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=211 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=105 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=102 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Body Mass Index (BMI) at Week 13	25.5 kg/m^2 Standard Deviation 6.3	29.2 kg/m^2 Standard Deviation 5.5	25.2 kg/m^2 Standard Deviation 7.5

SECONDARY outcome

Timeframe: 13 weeks

Mean participant-reported number of hypoglycemic events requiring carbohydrate treatment per 24 hours, based on the responses to the question, 'How many times in the last 24 hours did you take carbohydrates to treat a low blood sugar?' administered to participants once weekly during the 13-week RCT period.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=217 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=108 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=106 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Mean Participant-reported Number of Hypoglycemic Events Requiring Carbohydrate Treatment Per 24 Hours	1.0 Number of events in last 24 hours Standard Deviation 0.7	0.9 Number of events in last 24 hours Standard Deviation 0.7	0.8 Number of events in last 24 hours Standard Deviation 0.6

SECONDARY outcome

Timeframe: 13 weeks

Mean participant-reported number of hypoglycemic events requiring carbohydrate treatment per 24 hours, based on the responses to the question, 'Estimate the total amount of grams of carbohydrates you were given to treat these low blood sugars', which is a follow-up question to 'How many times in the last 24 hours did you take carbohydrates to treat a low blood sugar?'. Both questions were administered to participants once weekly during the 13-week RCT period.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=217 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=108 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=106 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Other Secondary Efficacy Endpoint: Mean Participant-reported Grams of Carbohydrate Taken Specifically to Prevent or Treat Hypoglycemic Events Per 24 Hours	12.7 grams in last 24 hours Standard Deviation 10.1	12.6 grams in last 24 hours Standard Deviation 12.0	12.5 grams in last 24 hours Standard Deviation 8.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Safety Outcome Measure: Severe hypoglycemia (SH) events with cognitive impairment requiring assistance of a third party for treatment.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Safety Outcome Measure: Severe Hypoglycemia Events	10 Participants	3 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Safety Outcome Measure: Diabetic ketoacidosis events (DKA) over 13 weeks as defined by the Diabetes Control and Complications Trial: symptoms such as polyuria, polydipsia, nausea, or vomiting; serum ketones >1.5 mmol/L or large/moderate urine ketones; either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and treatment provided in a health care facility.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Safety Outcome Measure: Diabetic Ketoacidosis Events	0 Participants	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Safety Outcome Measure: Serious adverse events excluding SH and DKA

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Safety Outcome Measure: Other Serious Adverse Events	3 Participants	0 Participants	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Safety Outcome Measure: Worsening of central lab hemoglobin A1c from baseline to week 13 by >0.5%. Glycated Hemoglobin A1C (HbA1c) is a physiological marker of the percentage of red blood cells that have glycated (bonded with a sugar). HbA1c is used to measure changes in average blood sugar over the past three months.

Outcome measures

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=212 Participants Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=111 Participants Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=104 Participants Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
Safety Outcome Measure: Worsening of HbA1c by >0.5%	17 Participants	7 Participants	8 Participants

Adverse Events

Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)

Serious events: 13 serious events

Other events: 119 other events

Deaths: 0 deaths

Bionic Pancreas iLet With Fiasp Insulin (BP-F)

Serious events: 5 serious events

Other events: 57 other events

Deaths: 0 deaths

Usual Care (UC)

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

Bionic Pancreas iLet With Inputted Blood Glucose Measurements Run-In (BG Run)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Transition to Usual Care With Bionic Pancreas iLet Guidance (BP)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Transition to Usual Care Without Bionic Pancreas iLet Guidance (UC)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Usual Care Crossover to Bionic Pancreas iLet Extension (BPX)

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 participants at risk Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 participants at risk Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 participants at risk Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months	Bionic Pancreas iLet With Inputted Blood Glucose Measurements Run-In (BG Run) n=58 participants at risk Upon completion of the RCT period, participants from the Bionic Pancreas iLet with Aspart/Lispro Insulin (BP-A/L) and Bionic Pancreas iLet with Fiasp Insulin (BP-F) groups voluntarily enrolled into the ancillary study testing iLet with inputted blood glucose measurements instead of CGM values for approximately 48 hours.	Transition to Usual Care With Bionic Pancreas iLet Guidance (BP) n=148 participants at risk Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP system.	Transition to Usual Care Without Bionic Pancreas iLet Guidance (UC) n=149 participants at risk Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on insulin regiments prior to enrolling in the RCT period.	Usual Care Crossover to Bionic Pancreas iLet Extension (BPX) n=90 participants at risk Upon completion of the RCT period for the Usual Care (UC) arm, select participants crossed over into the 3-month extension phase using the Bionic Pancreas with either Fiasp insulin or aspart/lispro insulin.
Endocrine disorders Severe Hypoglycemia	4.6% 10/219 • Number of events 10 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	2.6% 3/114 • Number of events 3 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.9% 2/107 • Number of events 3 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Endocrine disorders Diabetic ketoacidosis	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.8% 2/114 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Endocrine disorders Hypoglycemia	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Respiratory, thoracic and mediastinal disorders Epiglottitis	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Psychiatric disorders Attempted suicide	0.91% 2/219 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Respiratory, thoracic and mediastinal disorders Primary spontaneous pneumothorax	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Gastrointestinal disorders Abdominal pain	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.

Other adverse events

Measure	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L) n=219 participants at risk Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet \& Dexcom G6 CGM for 3 months	Bionic Pancreas iLet With Fiasp Insulin (BP-F) n=114 participants at risk Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet \& Dexcom G6 CGM for 3 months	Usual Care (UC) n=107 participants at risk Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months	Bionic Pancreas iLet With Inputted Blood Glucose Measurements Run-In (BG Run) n=58 participants at risk Upon completion of the RCT period, participants from the Bionic Pancreas iLet with Aspart/Lispro Insulin (BP-A/L) and Bionic Pancreas iLet with Fiasp Insulin (BP-F) groups voluntarily enrolled into the ancillary study testing iLet with inputted blood glucose measurements instead of CGM values for approximately 48 hours.	Transition to Usual Care With Bionic Pancreas iLet Guidance (BP) n=148 participants at risk Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP system.	Transition to Usual Care Without Bionic Pancreas iLet Guidance (UC) n=149 participants at risk Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on insulin regiments prior to enrolling in the RCT period.	Usual Care Crossover to Bionic Pancreas iLet Extension (BPX) n=90 participants at risk Upon completion of the RCT period for the Usual Care (UC) arm, select participants crossed over into the 3-month extension phase using the Bionic Pancreas with either Fiasp insulin or aspart/lispro insulin.
Endocrine disorders Hyperglycemia or ketosis events without meeting criteria for diabetic ketoacidosis	50.7% 111/219 • Number of events 214 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	43.9% 50/114 • Number of events 66 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	3.4% 2/58 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	2.7% 4/148 • Number of events 4 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	2.0% 3/149 • Number of events 3 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	45.6% 41/90 • Number of events 81 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Endocrine disorders Hypoglycemia	0.91% 2/219 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Skin and subcutaneous tissue disorders Allergic skin reaction	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Respiratory, thoracic and mediastinal disorders Bronchitis	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
General disorders Catheter infection	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
General disorders Catheter site pain	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.8% 2/114 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
General disorders Chest pain	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Nervous system disorders Concussion	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Gastrointestinal disorders Constipation	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Injury, poisoning and procedural complications Fall	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Gastrointestinal disorders Food poisoning	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Musculoskeletal and connective tissue disorders Foot fracture	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Gastrointestinal disorders Gastroenteritis	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Nervous system disorders Headache	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Skin and subcutaneous tissue disorders Ingrown toe nail	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
General disorders Injection site discomfort	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.8% 2/114 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
General disorders Injection site irritation	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Renal and urinary disorders Kidney stones	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Injury, poisoning and procedural complications Laceration	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Musculoskeletal and connective tissue disorders Leg fracture	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Gastrointestinal disorders Nausea	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Nervous system disorders Sciatica	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.93% 1/107 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Skin and subcutaneous tissue disorders Skin bacterial infection	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Psychiatric disorders Suicidal ideation	0.46% 1/219 • Number of events 2 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Renal and urinary disorders Urinary tract infection	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Reproductive system and breast disorders Vaginal bleeding	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.88% 1/114 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Nervous system disorders Vasovagal attack	0.46% 1/219 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/90 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Skin and subcutaneous tissue disorders Bruise	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Musculoskeletal and connective tissue disorders Ankle injury	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Respiratory, thoracic and mediastinal disorders Respiratory infection	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.
Skin and subcutaneous tissue disorders Contact dermatitis	0.00% 0/219 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/114 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/107 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/58 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/148 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	0.00% 0/149 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.	1.1% 1/90 • Number of events 1 • From protocol entry through last study date, which is approximately 13 weeks per participant with an additional 13 weeks (i.e. weeks 14-26) for BPX participants only.

Additional Information

Katrina Ruedy

Jaeb Center for Health Research

Phone: 813-975-8690

Email: kruedy@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place