The Insulin-Only Bionic Pancreas Pivotal Trial | NCT04200313

ID	Type	Description	Link
1UC4DK108612-01	U.S. NIH Grant/Contract		View source

Name	Class
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	NIH
Beta Bionics, Inc.	INDUSTRY
Boston University	OTHER
Massachusetts General Hospital

Description Module

Detailed Description

Primary Objective

• To compare the efficacy and safety of the insulin-only configuration of the iLet BP System (using insulin lispro, insulin aspart) the BP System using Fiasp (BPFiasp) [adults only]) in maintaining near-normal glycemia relative to usual care in a home-use study in adults and children with T1D.

Secondary Objectives • To assess the impact of the insulin-only configuration of the iLet BP System on quality of life and treatment satisfaction.

The study has four major parts: (1) the Test-Run Phase, (2) the RCT Period, (3) the Extension Phase for the UC Arm, and (4) the Transition Phase. These four parts are described below, and detailed in the main part of the protocol.

A Test-Run Phase will be conducted to (1) test the functionality of all aspects of the iLet BP System, (2) train the clinical staff on the execution of the clinical protocol, and (3) provide hands-on training with the device prior to initiating the RCT Period. The initial test run will be conducted at one site (MGH) with ~5 participants using the iLet BP system for 4-7 days. If there are no safety or consequential device issues, a test run will be conducted at each of the other 15 sites, with ~2 participants per site using the iLet BP system for 4-7 days. The iLet BP system will use insulin lispro or insulin aspart. Results of this Test-Run Phase will be evaluated for safety prior to beginning the RCT Period as described in section 3.3.

The 13-week, parallel-group, multi-center RCT Period is designed to compare the insulin-only iLet BP Group using insulin lispro, insulin aspart, or Fiasp (adults only); and a control group following usual care (UC Group). Upon completion of the RCT Period, the BP Group will enter the 2-4 day Transition Phase and the UC Group will enter the Extension Phase.

The UC Group Extension Phase will immediately follow the RCT Period. Participants from the UC Group who complete the primary outcome visit, miss no more than 3 of the maximum possible number of the weekly questionnaires, attend all clinic visits, and follow study procedures for collecting CGM data during the RCT Period, will be given the option to use the iLet BP system for 13 weeks. The visit schedule and procedures for the Extension Phase will be similar to that of the BP Group in the RCT Period.

A 2-4 day Transition Phase will be conducted for all participants who complete BP use at the end of the RCT Period (BP Group). Participants will be randomly assigned (1:1) to either transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP system or transition back to their usual mode of therapy based on what their own insulin regimens were prior to enrolling in the RCT Period. For those randomized to using their pre-study regimens, the dosing can be adjusted by the investigator to mitigate safety issues but should follow pre-study regimen as closely as possible.

An optional ancillary study will be offered to participants who are using the iLet at the time of the 13-week randomized trial visit. This will will assess the safety of utilizing blood glucose measurements instead of CGM measurements as input into the iLet for ~48-60 hours. It will be completed at the end of the RCT for those in the BP Group prior to the Transition Phase.

Test-Run Visit and Phone Contact Schedule

Screening Visit - Eligibility assessed, informed consent, point-of-care/local HbA1c, testing and procedures similar to the RCT Screening Visit including psychosocial questionnaires; if eligible, BP system started.

o For participants who completed the separate screening protocol, eligibility will be reassessed. Point-of-care/local HbA1c will be obtained if more than 28 days have elapsed. Participants will not need to repeat the psychosocial questionnaires.
Phone contact after 1-2 days
Shut-down visit at the end of the study period 4-7 days

RCT Period Visit and Phone Contact Schedule

Screening Visit (which may be completed as part of a separate screening protocol)
- Eligibility assessed, informed consent signed, point-of-care/local HbA1c, psychosocial questionnaires completed, blinded Dexcom G6 CGM sensor placed for non Dexcom G6 users.
  - For baseline data collection, participants using a personal Dexcom G6 who have at least 85% of possible glucose data in last 14 days can skip the blinded CGM wear
  - Participants using a personal Dexcom G6 with <85% of data will use their personal Dexcom G6.
  - For participants who completed the separate screening protocol, eligibility will be reassessed. Point-of-care/local HbA1c will be obtained if more than 28 days have elapsed. Participants will not need to repeat the psychosocial questionnaires or blinded CGM wear.
If the separate screening protocol or Test Run Phase of this protocol was completed or blinded CGM wear is not needed, randomization can proceed immediately. If blinded CGM wear was performed as part of this protocol, randomization visit will occur14-21 days after screening.
Prior to randomization, eligibility will be reassessed and blood drawn for central lab HbA1c
BP study start/UC study start on day of Randomization Visit
Phone contacts after 1-2 days and 7 (±2) days
Visits at 2 weeks (±4 days), 6 weeks (±4 days), 10 weeks (±4 days), and ~13 weeks (91-98 days from randomization):
- Participants in the UC Group will wear a blinded Dexcom G6 sensor throughout the entire study unless they are current users of the Dexcom G6 CGM, in which case they will continue to use their own Dexcom G6 CGM.
- At the 6-week and 13-week visits, central lab HbA1c determination and psychosocial questionnaires

UC Group Extension Phase Visit and Phone Contact Schedule

BP initiation at 13-week visit
Phone contacts after 13 weeks plus 1-2 days and 14 weeks (±2 days)
Visits at 15 weeks (± 4 days), 19 (±4 days), 23 (±4 days), and ~26 weeks (182-189 days):
- At the 19-week and 26-week visits, central lab HbA1c determination and psychosocial questionnaires

Transition Phase Visit Schedule

Randomization and transition to UC regimen at 13-week visit for RCT BP Group for a period of 2-4 days in duration.
Visit ≤4 days later for end of study

Ancillary Study Day 1 (13-week visit of the RCT) - stop CGM, start blinded CGM, start SMBG at least every 2 hours during waking hours and at least once during each overnight for the next 48-60hrs.

Day 2: Phone call for safety

Day 3: stop iLet, stop blinded CGM, restart unblinded CGM, enter Transition Phase.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bionic Pancreas (BP)	Experimental	Some adults and 1/2 peds will be randomized to use the Bionic Pancreas (BP) with lispro or aspart for 13 weeks	Combination Product: Bionic Pancreas (BP) with Aspart or Lispro
Bionic Pancreas with Fiasp (BPFiasp)	Experimental	Some adults will be randomized to use the Bionic Pancreas (BP) with Fiasp for 13 weeks during RCT	Combination Product: Bionic Pancreas with Fiasp (BPFiasp)
Usual Care (UC)	Other	Adults and peds will use their own diabetes insulin regimen plus continuous glucose monitoring (CGM) during the RCT	Other: Usual Care (UC)
Bionic Pancreas Extension	Experimental	Used by all participants in the EXT study	Combination Product: Bionic Pancreas (BP) with Aspart or Lispro Combination Product: Bionic Pancreas with Fiasp (BPFiasp)
Transition Phase - BP Guidance	Experimental	Adults and peds will use their own diabetes insulin regimen plus SMBG and blinded continuous glucose monitoring (CGM) in the Transition phase and use dosing based on guidance from the BP system

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bionic Pancreas (BP) with Aspart or Lispro	Combination Product	iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor using lispro or aspart insulin.

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

Measure	Description	Time Frame
Non-inferiority for CGM-measured Time <54 mg/dL (Key Secondary Endpoint)	The key secondary endpoint is CGM-measured time <54 mg/dL over 13 weeks	13 weeks
CGM-measured Mean Glucose Level Over 13 Weeks

Measure	Description	Time Frame
Safety Outcome Measure: Severe Hypoglycemia Events	Safety Outcome Measure: Severe hypoglycemia (SH) events with cognitive impairment requiring assistance of a third party for treatment.	13 weeks
Safety Outcome Measure: Diabetic Ketoacidosis Events

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Clinical diagnosis of T1D for at least one year and using insulin for at least 1 year 2. Diabetes managed using the same regimen (either pump or MDI, with or without CGM) for ≥ 3 months

3. Age ≥ 6 years old
- Exception: the initial 5-participant test run will be limited to >18 years old
  
  4. Current use of a CGM, or if not a CGM user, at least 3 blood glucose meter tests daily on average over the last 4 weeks (according to judgment of investigator if meter is not available).
  
  5. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
  
  6. For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia.
  
  7. For participants >18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and can't be reached.
  
  8. Investigator believes that the participant can safely use the iLet and will follow the protocol
- The investigator will take into account the participant's HbA1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on HbA1c specified for eligibility.
  
  9. If a GLP-1 agonist or pramlintide is being used, participant must be willing to discontinue use while the iLet BP system is being used, including the randomized trial and extension study.

Exclusion Criteria:

Eligibility may be assessed initially in a separate screening protocol or at a screening visit in the RCT protocol. To be eligible for all phases of the study, a participant must meet all of the following inclusion criteria and none of the exclusion criteria:

Exclusion

Unable to provide informed consent (e.g. impaired cognition or judgment)
Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision or dexterity that prevents safe operation of the bionic pancreas, impaired memory)
Unable to speak and read English

• For pediatric participants, both caregivers and participants must be able to speak and read English
Plan to change usual diabetes regimen in the next 3 months
- This would include changing from MDI to pump. pump to MDI, change in insulin automation delivery system, starting a CGM if not previously used, changes in drug therapy specifically for glucose control except for changes in one insulin analog to another.
- Changes in insulin dose, carb ratio, sensitivity factor and basal rate profile are allowed.
Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system
Use of Apidra as the pre-study rapid-acting insulin analog and unwilling to switch to lispro or aspart for the duration of the study
Known hemoglobinopathy (sickle cell trait is not an exclusion)
Current participation in another diabetes-related clinical trial
History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy
Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference
Established history of allergy or severe reaction to adhesive or tape that must be used in the study
Current use of SGLT2 inhibitors or a sulfonylurea drug (use more than 3 months prior to enrollment is acceptable)

• If using GLP1 agonist, pramlintide, or metformin drugs must be on a stable dose for 3 months prior to enrollment (and as per inclusion criterion #8, must be willing to discontinue use of GLP-1 agonist or pramlintide while using the iLet BP system during the RCT and the extension phase).
Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 3 months, or sexually active without use of contraception
For adults >18 years old, most recent (must be within the last 2 years) eGFR <30 ml/min OR currently in renal failure on dialysis

• If no eGFR is available for an adult participant during the last 2 years, one must be obtained to confirm eligibility
Presence of a medical condition or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant. Conditions to be considered by the investigator may include the following:
- Alcohol or drug abuse
- Use of prescription drugs that may dull the sensorium, reduce sensitivity to symptoms of hypoglycemia, or hinder decision making during the period of participation in the study
- Coronary artery disease that is not stable with medical management, including unstable angina, angina that prevents moderate exercise (e.g. climbing a flight of stairs) despite medical management, or within the last 12 months before screening a history of myocardial infarction, percutaneous coronary intervention, enzymatic lysis of a presumed coronary occlusion, or coronary artery bypass grafting
- Congestive heart failure with New York Heart Association (NYHA) Functional Classification III or IV
- History of TIA or stroke in the last 12 months
- Untreated or inadequately treated mental illness
- History of eating disorder within the last 2 years, such as anorexia, bulimia, or diabulemia or omission of insulin to manipulate weight
- History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment
Employed by, or having immediate family members employed by Beta Bionics, or being directly involved in conducting the clinical trial, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Name	Affiliation	Role
R. Paul Wadwa, MD	University of Colorado, Denver	Principal Investigator
Mark Daniels, MD	Children's Hospital of Orange County	Principal Investigator
Fran Cogen, MD	Children's National Research Institute	Principal Investigator
Keren Zhou, MD	The Cleveland Clinic	Principal Investigator
Andrew Muir, MD	Emory University	Principal Investigator
Davida Kruger, NP	Henry Ford Health System	Principal Investigator
Steven J Russell, MD	Massachusetts General Hospital	Principal Investigator
Robin Goland, MD	Naomi Berrie Center - Columbia University	Principal Investigator
Nelly Mauras, MD	Nemours Children's Health System	Principal Investigator
Bruce Buckingham, MD

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Orange County (Pediatrics)		Orange	California	92868	United States
University of California - San Diego (Adults)

PubMed Identifier	Type	Citation	Retractions
36173237	Background	Messer LH, Buckingham BA, Cogen F, Daniels M, Forlenza G, Jafri RZ, Mauras N, Muir A, Wadwa RP, White PC, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro CA, Li Z, Marak MC, Calhoun P, Beck RW. Positive Impact of the Bionic Pancreas on Diabetes Control in Youth 6-17 Years Old with Type 1 Diabetes: A Multicenter Randomized Trial. Diabetes Technol Ther. 2022 Oct;24(10):712-725. doi: 10.1089/dia.2022.0201.pub.
36877259	Background

ID	Title	Description
FG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
FG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 25, 2021	Jul 11, 2023

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

HbA1c

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

Posted

Mean

Standard Deviation

mmol/mol

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000219 OG001114 OG002107

Title

Denominators

Categories

Title	Measurements
	OG00056± 7.7 OG00154± 6.6 OG00261± 10.9

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG002		Mixed Models Analysis		<0.001														Superiority
OG001 OG002		Mixed Models Analysis		<0.001

Secondary

Non-inferiority for CGM-measured Time <54 mg/dL (Key Secondary Endpoint)

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

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

CGM-measured Mean Glucose Level Over 13 Weeks

Posted

Mean

Standard Deviation

mg/dL

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-measured Percentage Time 70-180 mg/dL Over 13 Weeks

Posted

Mean

Standard Deviation

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-measured Percentage Time >180 mg/dL Over 13 Weeks

Posted

Mean

Standard Deviation

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-measured Percentage Time >250 mg/dL Over 13 Weeks

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-measured Glucose Standard Deviation (SD) mg/dL Over 13 Weeks

Posted

Mean

Standard Deviation

mg/dL

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-Measured Percentage Time <70 mg/dL Over 13 Weeks

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-measured Percentage Time <54 mg/dL Over 13 Weeks

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

CGM-Measured Glucose Coefficient of Variation Over 13 Weeks

Posted

Mean

Standard Deviation

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: HbA1c <7.0%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c <7.0% in Participants With Baseline HbA1c >7.5%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c <7.5%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c <8.0%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c >9.0%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c Improvement >0.5%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c Relative Improvement >10%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0% or HbA1c <7.0% at 13 Weeks

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-140 mg/dL Over 13 Weeks

Posted

Mean

Standard Deviation

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-120 mg/dL Over 13 Weeks

Posted

Mean

Standard Deviation

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <60 mg/dL Over 13 Weeks

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Area Over the Curve 70 mg/dL Over 13 Weeks

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

Posted

Median

Inter-Quartile Range

mg/dL

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)

Secondary

Other Secondary Efficacy Endpoint: Low Blood Glucose Index (LBGI)

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

Posted

Median

Inter-Quartile Range

units on a scale

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Hypoglycemic Events

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

Posted

Median

Inter-Quartile Range

Number of events per week

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Hyperglycemic Events

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

Posted

Median

Inter-Quartile Range

Number of events per week

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time >300 mg/dL Over 13 Weeks

Posted

Median

Inter-Quartile Range

Percentage

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Area Under the Curve 180 mg/dL Over 13 Weeks

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

Posted

Median

Inter-Quartile Range

mg/dL

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)

Secondary

Other Secondary Efficacy Endpoint: High Blood Glucose Index (HBGI)

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

Posted

Median

Inter-Quartile Range

units on a scale

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts

Secondary

Other Secondary Efficacy Endpoint: Mean of Daily Difference in Mean Glucose

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

Posted

Mean

Standard Deviation

mg/dL

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-180 mg/dL >70% Over 13 Weeks

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <70 mg/dL <4%

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <54 mg/dL <1%

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: Blood Glucose Risk Index (LBGI + HBGI)

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

Posted

Median

Inter-Quartile Range

units on a scale

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months

Secondary

Other Secondary Efficacy Endpoint: Improvement in HbA1c > 0.5% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without an Increase in HbA1c by > 0.5%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months

Secondary

Other Secondary Efficacy Endpoint: Improvement in Time 70-180 mg/dl by >10% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without a Decrease in Time 70-180 mg/dl by > 10%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: Mean Glucose <154 mg/dL and Time <54 mg/dL <1%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%

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

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: Total Daily Insulin (Units/kg)

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

Posted

Mean

Standard Deviation

Insulin units per kg

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: Percentage Change in the TDD of Insulin Over the First Two-week Period Relative to the TDD of Insulin in the Last Two-week Period

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

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

Posted

Mean

Standard Deviation

Percentage change

Weeks 1-2 and weeks 12-13

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months

Units	Counts
Participants

Secondary

Other Secondary Efficacy Endpoint: Body Weight at Week 13

Posted

Mean

Standard Deviation

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: Body Mass Index (BMI) at Week 13

Posted

Mean

Standard Deviation

kg/m^2

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants	OG000

Secondary

Other Secondary Efficacy Endpoint: Mean Participant-reported Number of Hypoglycemic Events Requiring Carbohydrate Treatment Per 24 Hours

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

Posted

Mean

Standard Deviation

Number of events in last 24 hours

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Secondary

Other Secondary Efficacy Endpoint: Mean Participant-reported Grams of Carbohydrate Taken Specifically to Prevent or Treat Hypoglycemic Events Per 24 Hours

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

Posted

Mean

Standard Deviation

grams in last 24 hours

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Other Pre-specified

Safety Outcome Measure: Severe Hypoglycemia Events

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Other Pre-specified

Safety Outcome Measure: Diabetic Ketoacidosis Events

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Other Pre-specified

Safety Outcome Measure: Other Serious Adverse Events

Safety Outcome Measure: Serious adverse events excluding SH and DKA

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Units	Counts
Participants

Other Pre-specified

Safety Outcome Measure: Worsening of HbA1c by >0.5%

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

Posted

Count of Participants

Participants

13 weeks

ID	Title	Description
OG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
OG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
OG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months	219	13	219	119	219
EG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months	114	5	114	57	114
EG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months	107	4	107	4	107
EG003	Bionic Pancreas iLet With Inputted Blood Glucose Measurements Run-In (BG Run)	Upon completion of the RCT period, participants from the Bionic Pancreas iLet with Aspart/Lispro Insulin (BP-A/L) and Bionic Pancreas iLet with Fiasp Insulin (BP-F) groups voluntarily enrolled into the ancillary study testing iLet with inputted blood glucose measurements instead of CGM values for approximately 48 hours.	58	0	58	2	58
EG004	Transition to Usual Care With Bionic Pancreas iLet Guidance (BP)	Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on therapeutic guidance from the iLet BP system.	148	0	148	4	148
EG005	Transition to Usual Care Without Bionic Pancreas iLet Guidance (UC)	Upon completion of either a) the RCT period for the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) or Bionic Pancreas iLet with Fiasp insulin (BP-F) arms, or b) the Ancillary Study Testing iLet with Inputted Blood Glucose Measurements period, whichever is later, participants were randomized to transition back to their usual mode of therapy (MDI or pump therapy) based on insulin regiments prior to enrolling in the RCT period.	149	0	149	3	149
EG006	Usual Care Crossover to Bionic Pancreas iLet Extension (BPX)	Upon completion of the RCT period for the Usual Care (UC) arm, select participants crossed over into the 3-month extension phase using the Bionic Pancreas with either Fiasp insulin or aspart/lispro insulin.	90	3	90	43	90

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Hyperglycemia or ketosis events without meeting criteria for diabetic ketoacidosis	Endocrine disorders	Systematic Assessment	EG000214 events111 affected219 at risk EG00166 events50 affected114 at risk EG0022 events1 affected107 at risk EG0032 events2 affected58 at risk EG004
Hypoglycemia	Endocrine disorders	Systematic Assessment	EG0002 events2 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Allergic skin reaction	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Bronchitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Catheter infection	General disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Catheter site pain	General disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected114 at risk EG0020 events0 affected107 at risk EG003
Chest pain	General disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Concussion	Nervous system disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Food poisoning	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Foot fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Gastroenteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0021 events1 affected107 at risk EG003
Headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Ingrown toe nail	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Injection site discomfort	General disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected114 at risk EG0020 events0 affected107 at risk EG003
Injection site irritation	General disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0021 events1 affected107 at risk EG003
Kidney stones	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Leg fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0021 events1 affected107 at risk EG003
Skin bacterial infection	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Suicidal ideation	Psychiatric disorders	Systematic Assessment	EG0002 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Urinary tract infection	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Vaginal bleeding	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0011 events1 affected114 at risk EG0020 events0 affected107 at risk EG003
Vasovagal attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Bruise	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Ankle injury	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Respiratory infection	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Contact dermatitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D061268	Insulin Lispro
D061267	Insulin Aspart

ID	Term
D061266	Insulin, Short-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

ID	Title	Description
BG000	Bionic Pancreas iLet With Aspart/Lispro Insulin (BP-A/L)	Participants randomized to the Bionic Pancreas iLet with aspart/lispro insulin (BP-A/L) arm will use the iLet & Dexcom G6 CGM for 3 months
BG001	Bionic Pancreas iLet With Fiasp Insulin (BP-F)	Participants randomized to the Bionic Pancreas iLet with Fiasp insulin (BP-F) arm will use the iLet & Dexcom G6 CGM for 3 months
BG002	Usual Care (UC)	Participants randomized to Usual Care (UC) will continue using their usual insulin delivery method and a study CGM (Dexcom G6) for 3 months
BG003	Total	Total of all reporting groups

Term	Organ System	Assessment Type	Statistical Information
Severe Hypoglycemia	Endocrine disorders	Systematic Assessment	EG00010 events10 affected219 at risk EG0013 events3 affected114 at risk EG0023 events2 affected107 at risk EG0030 events0 affected58 at risk EG0040 events0 affected148 at risk EG0050 events0 affected149 at risk EG0062 events1 affected90 at risk
Diabetic ketoacidosis	Endocrine disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0012 events2 affected114 at risk EG0020 events0 affected107 at risk EG003
Hypoglycemia	Endocrine disorders	Systematic Assessment	EG0001 events1 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Epiglottitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0021 events1 affected107 at risk EG003
Attempted suicide	Psychiatric disorders	Systematic Assessment	EG0002 events2 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003
Primary spontaneous pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0021 events1 affected107 at risk EG003
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected219 at risk EG0010 events0 affected114 at risk EG0020 events0 affected107 at risk EG003