Trial Outcomes & Findings for Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth (NCT NCT05168657)

NCT ID: NCT05168657

Last Updated: 2024-10-21

Results Overview

The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 54 participants
• Primary outcome timeframe: BP Arm Days 3-14
• Results posted on: 2024-10-21

Participant Flow

Participant milestones

Measure	EN-IP-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-TH-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-IP-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-TH-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-IP-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-TH-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-IP-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-TH-BP First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes
Overall Study STARTED	5	5	5	5	5	5	5	5
Overall Study COMPLETED	5	5	4	5	5	5	5	5
Overall Study NOT COMPLETED	0	0	1	0	0	0	0	0

Reasons for withdrawal

Measure	EN-IP-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-TH-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-IP-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	EN-TH-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-IP-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-TH-UC First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-IP-BP First, Then UC Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes	PC-TH-BP First, Then BP Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes
Overall Study Adverse Event	0	0	1	0	0	0	0	0

Baseline Characteristics

Feasibility of Closed-loop Automated Insulin Delivery System by Primary Care & Endocrinology, in Person & Via Telehealth

Baseline characteristics by cohort

Measure	EN-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	36 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 15.3 • n=5 Participants	45.7 years STANDARD_DEVIATION 12.3 • n=7 Participants	44.6 years STANDARD_DEVIATION 13.5 • n=5 Participants	44.4 years STANDARD_DEVIATION 16.7 • n=4 Participants	44.8 years STANDARD_DEVIATION 14.0 • n=21 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	7 Participants n=4 Participants	23 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	8 Participants n=5 Participants	9 Participants n=4 Participants	37 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	6 Participants n=4 Participants	34 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	40 participants n=21 Participants
Body Mass Index (BMI)	27.3 kg/m^2 STANDARD_DEVIATION 5.3 • n=5 Participants	29.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=7 Participants	25.8 kg/m^2 STANDARD_DEVIATION 2.8 • n=5 Participants	27.5 kg/m^2 STANDARD_DEVIATION 4.9 • n=4 Participants	27.5 kg/m^2 STANDARD_DEVIATION 4.5 • n=21 Participants
HbA1c	7.3 % (of hemoglobin that is glycosylated STANDARD_DEVIATION 1.1 • n=5 Participants	7.2 % (of hemoglobin that is glycosylated STANDARD_DEVIATION 0.3 • n=7 Participants	6.8 % (of hemoglobin that is glycosylated STANDARD_DEVIATION 0.6 • n=5 Participants	7.0 % (of hemoglobin that is glycosylated STANDARD_DEVIATION 1.1 • n=4 Participants	7.1 % (of hemoglobin that is glycosylated STANDARD_DEVIATION 0.8 • n=21 Participants
Diabetes duration	26.4 years STANDARD_DEVIATION 15.8 • n=5 Participants	31.5 years STANDARD_DEVIATION 10.9 • n=7 Participants	15.2 years STANDARD_DEVIATION 12.3 • n=5 Participants	21.3 years STANDARD_DEVIATION 16.0 • n=4 Participants	23.6 years STANDARD_DEVIATION 14.7 • n=21 Participants

PRIMARY outcome

Timeframe: BP Arm Days 3-14

Population: Our primary outcome measure is restricted to the BP arm only, as pre-specified in the protocol. UC arm data is not relevant to this measure. One EN-IP participant was excluded from analysis because they withdrew from the study before beginning the BP arm; therefore 9 rather than 10 participants were included in the analysis for this group.

The outcome is categorical, and the primary outcome is not a direct comparison of the mean CGM glucose between the groups.

Outcome measures

Measure	EN-IP n=9 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.
Percentage of Individuals With Mean CGM Glucose <183 mg/dL (Corresponding to an Estimated HbA1c of <8.0%) on Days 3-14, by Group.	89 percentage of participants	100 percentage of participants	100 percentage of participants	100 percentage of participants

SECONDARY outcome

Timeframe: BP Arm Days 3-14

Population: This secondary outcome measure is restricted to the BP arm only, as pre-specified in the protocol. UC arm data is not relevant to this measure. One EN-IP participant was excluded from analysis because they withdrew from the study before beginning the BP arm; therefore 9 rather than 10 participants were included in the analysis for this group.

Individual CGM values from days 3-14 were averaged together for each participant.

Outcome measures

Measure	EN-IP n=9 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.
Mean CGM Glucose on Days 3-14	155.9 mg/dL Standard Deviation 56.3	152.5 mg/dL Standard Deviation 52.2	145.0 mg/dL Standard Deviation 48.0	152.6 mg/dL Standard Deviation 44.8

SECONDARY outcome

Timeframe: BP Arm Days 3-14

Population: This secondary outcome measure is restricted to the BP arm only, as pre-specified in the protocol. UC arm data is not relevant to this measure. One EN-IP participant was excluded from analysis because they withdrew from the study before beginning the BP arm; therefore 9 rather than 10 participants were included in the analysis for this group.

Calculated from all individual CGM values from days 3-14 for each participant.

Outcome measures

Measure	EN-IP n=9 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.
Percentage of Time With CGM Glucose <54 mg/dl on Days 3-14	0.48 percentage of time Interval 0.17 to 0.97	0.18 percentage of time Interval 0.0 to 0.95	0.14 percentage of time Interval 0.06 to 0.43	0.00 percentage of time Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: BP Arm Days 3-14

Population: This secondary outcome measure is restricted to the BP arm only, as pre-specified in the protocol. UC arm data is not relevant to this measure. One EN-IP participant was excluded from analysis because they withdrew from the study before beginning the BP arm; therefore 9 rather than 10 participants were included in the analysis for this group.

Calculated from all individual CGM values from days 3-14 for each participant.

Outcome measures

Measure	EN-IP n=9 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.
Percentage of Time With CGM Glucose in the 70-180 mg/dl Range on Days 3-14	67.9 percentage of time Standard Deviation 10.8	71.6 percentage of time Standard Deviation 5.0	78.6 percentage of time Standard Deviation 10.2	75.1 percentage of time Standard Deviation 8.6

SECONDARY outcome

Timeframe: BP Arm Days 3-14

Population: This secondary outcome measure is restricted to the BP arm only, as pre-specified in the protocol. UC arm data is not relevant to this measure. One EN-IP participant was excluded from analysis because they withdrew from the study before beginning the BP arm; therefore 9 rather than 10 participants were included in the analysis for this group.

Calculated from all individual CGM values from days 3-14 for each participant.

Outcome measures

Measure	EN-IP n=9 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by ENDOCRINOLOGY with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.	PC-IP n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with IN PERSON visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH n=10 Participants Random-order cross-over participants on BIONIC PANCREAS managed by PRIMARY CARE with TELEHEALTH visits. Participants will be randomly assigned to initiate trial participation with either Bionic Pancreas intervention or Usual Care intervention, followed by the other intervention. Each intervention will consist of 14 days. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery. Telehealth: Study participation will be managed via telehealth visits.
Percentage of Individuals With Mean CGM Glucose <154 mg/dL (Corresponding to an Estimated HbA1c of <7.0%) on Days 3-14, by Group.	67 percentage of participants	50 percentage of participants	80 percentage of participants	60 percentage of participants

Adverse Events

PC Pre-randomization

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

EN Pre-randomization

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

PC-IP-UC

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PC-IP-BP

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

PC-TH-UC

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

PC-TH-BP

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

EN-IP-UC

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

EN-IP-BP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EN-TH-UC

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

EN-TH-BP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PC Between Arms

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EN Between Arms

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	PC Pre-randomization n=20 participants at risk Random-order cross-over participants managed by PRIMARY CARE who were not yet randomized.	EN Pre-randomization n=20 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY who were not yet randomized.	PC-IP-UC n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	PC-IP-BP n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH-UC n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	PC-TH-BP n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-IP-UC n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	EN-IP-BP n=9 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH-UC n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	EN-TH-BP n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC Between Arms n=20 participants at risk Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period.	EN Between Arms n=19 participants at risk Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period.
Nervous system disorders Seizure	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Endocrine disorders Severe hypoglycemia	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	5.0% 1/20 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Skin and subcutaneous tissue disorders Abscess in right axilla	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	5.0% 1/20 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.

Other adverse events

Measure	PC Pre-randomization n=20 participants at risk Random-order cross-over participants managed by PRIMARY CARE who were not yet randomized.	EN Pre-randomization n=20 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY who were not yet randomized.	PC-IP-UC n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	PC-IP-BP n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC-TH-UC n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	PC-TH-BP n=10 participants at risk Random-order cross-over participants managed by PRIMARY CARE with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-IP-UC n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	EN-IP-BP n=9 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with IN-PERSON visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	EN-TH-UC n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Usual Care, followed by 14 days of Bionic Pancreas. There was no washout period between arms. Usual Care: 14 days of the participant's usual care of their type 1 diabetes.	EN-TH-BP n=10 participants at risk Random-order cross-over participants managed by ENDOCRINOLOGY with TELEHEALTH visits, assigned by randomization to undergo 14 days of Bionic Pancreas, followed by 14 days of Usual Care. There was no washout period between arms. Bionic Pancreas: 14 days using the insulin-only configuration of the iLet Bionic Pancreas (Beta Bionics, Inc.), which automates insulin delivery, as the only intended mode of insulin delivery.	PC Between Arms n=20 participants at risk Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period.	EN Between Arms n=19 participants at risk Participants had up to 14 days from the stop of Arm 1 to schedule the start of Arm 2. This was not a washout period.
Skin and subcutaneous tissue disorders Dermatofibroma	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Endocrine disorders Hyperglycemia	5.0% 1/20 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	20.0% 2/10 • Number of events 2 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Infections and infestations Sinus infection	5.0% 1/20 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Skin and subcutaneous tissue disorders Injection site reaction	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
General disorders Illness/Cold/Flu	15.0% 3/20 • Number of events 3 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	5.0% 1/20 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	20.0% 2/10 • Number of events 2 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	5.3% 1/19 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Musculoskeletal and connective tissue disorders Carpal tunnel surgery	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	10.0% 1/10 • Number of events 1 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.
Eye disorders Cataract Surgery	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	5.0% 1/20 • Number of events 2 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/9 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/10 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/20 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.	0.00% 0/19 • Adverse event data were collected for each participant from the time of their enrollment through completion of the study, resolution of any adverse events if applicable, or until lost to follow-up. This ranged from approximately 30 days to 4 months, per participant. Adverse events were assessed systematically at each participant visit following enrollment and non-systematically via self-report. One EN-IP-BP participant withdrew from the study before beginning the BP arm; therefore 4 rather than 5 participants were at-risk for this group.

Additional Information

Dr. Sean Oser

University of Colorado

Phone: 3037245828

Email: sean.oser@cuanschutz.edu

Results disclosure agreements

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