The Insulin-Only Bionic Pancreas Pivotal Trial

NCT ID: NCT04200313

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2022-01-14

Brief Summary

This multi-center randomized control trial (RCT) will compare efficacy and safety endpoints using the insulin-only configuration of the iLet Bionic Pancreas (BP) System versus Usual Care (UC) during a 13-week study period. Participants may be enrolled initially into a screening protocol and then transfer into the RCT protocol, or they may enter directly into the RCT protocol. The RCT will be followed by an Extension Phase in which the RCT Usual Care (UC) Group will use the insulin-only configuration of the iLet Bionic Pancreas (BP) System for 3 months. At the completion of use of the BP system in the RCT only, participants will enter a 2-4 day Transition Phase and be randomly assigned 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.

There is an optional ancillary study to assess the safety of utilizing self-monitored blood glucose (SMBG) measurements instead of continuous glucose monitor (CGM) measurements as input into the iLet for ~48-60 hours. The Study is intended to mirror a real-world situation where CGM may not be available for an extended period of time (eg, user runs out of sensors and is awaiting new shipment).

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.

Conditions

Diabetes Mellitus; Type 1 Diabetes; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bionic Pancreas (BP)

Some adults and 1/2 peds will be randomized to use the Bionic Pancreas (BP) with lispro or aspart for 13 weeks

Group Type: EXPERIMENTAL

Bionic Pancreas (BP) with Aspart or Lispro

Intervention Type: 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.

Bionic Pancreas with Fiasp (BPFiasp)

Some adults will be randomized to use the Bionic Pancreas (BP) with Fiasp for 13 weeks during RCT

Group Type: EXPERIMENTAL

Bionic Pancreas with Fiasp (BPFiasp)

Intervention Type: COMBINATION_PRODUCT

iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls Fiasp insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.

Usual Care (UC)

Adults and peds will use their own diabetes insulin regimen plus continuous glucose monitoring (CGM) during the RCT

Group Type: OTHER

Usual Care (UC)

Intervention Type: OTHER

Using pre-study insulin regimen with the Dexcom G6 CGM

Bionic Pancreas Extension

Used by all participants in the EXT study

Group Type: EXPERIMENTAL

Bionic Pancreas (BP) with Aspart or Lispro

Intervention Type: 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.

Bionic Pancreas with Fiasp (BPFiasp)

Intervention Type: COMBINATION_PRODUCT

iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls Fiasp insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.

Transition Phase - BP Guidance

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

Group Type: EXPERIMENTAL

Usual Care (UC)

Intervention Type: OTHER

Using pre-study insulin regimen with the Dexcom G6 CGM

BP Guidance Insulin Dosing

Intervention Type: OTHER

Pre-study insulin delivery method with SMBG and blinded CGM with dosing guidance by the BP

Transition- Pre-study dosing

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 their pre-study regimen

Group Type: OTHER

Usual Care (UC)

Intervention Type: OTHER

Using pre-study insulin regimen with the Dexcom G6 CGM

Interventions

Bionic Pancreas (BP) with Aspart or Lispro

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.

Intervention Type: COMBINATION_PRODUCT

Bionic Pancreas with Fiasp (BPFiasp)

iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls Fiasp insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.

Intervention Type: COMBINATION_PRODUCT

Usual Care (UC)

Using pre-study insulin regimen with the Dexcom G6 CGM

Intervention Type: OTHER

BP Guidance Insulin Dosing

Pre-study insulin delivery method with SMBG and blinded CGM with dosing guidance by the BP

Intervention Type: OTHER

Other Intervention Names

iLet

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

1. Unable to provide informed consent (e.g. impaired cognition or judgment)

2. 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)

3. Unable to speak and read English

• For pediatric participants, both caregivers and participants must be able to speak and read English

4. 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.

5. Current use of non-FDA approved closed-loop or hybrid closed-loop insulin delivery system

6. 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

7. Known hemoglobinopathy (sickle cell trait is not an exclusion)

8. Current participation in another diabetes-related clinical trial

9. History of cystic fibrosis, pancreatitis, or other pancreatic disease, including pancreatic tumor or insulinoma, or history of complete pancreatectomy

10. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to RF interference

11. Established history of allergy or severe reaction to adhesive or tape that must be used in the study

12. 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).

13. Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 3 months, or sexually active without use of contraception

14. 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

15. 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

16. 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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Beta Bionics, Inc.

INDUSTRY

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

R. Paul Wadwa, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Mark Daniels, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Orange County

Fran Cogen, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Keren Zhou, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Andrew Muir, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Davida Kruger, NP

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Steven J Russell, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Robin Goland, MD

Role: PRINCIPAL_INVESTIGATOR

Naomi Berrie Center - Columbia University

Nelly Mauras, MD

Role: PRINCIPAL_INVESTIGATOR

Nemours Children's Health System

Bruce Buckingham, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jeremy Pettus, MD

Role: PRINCIPAL_INVESTIGATOR

UC-San Diego

John Buse, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Irl Hirsch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Jane Lynch, MD

Role: PRINCIPAL_INVESTIGATOR

UT Health Science Center - San Antonio

Perrin White, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas, Southwestern Medical Center at Dallas

Janet McGill, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Jill Weissberg-Benchell, PhD

Role: PRINCIPAL_INVESTIGATOR

Lurie Children's Hospital

Roy Beck, MD, PhD

Role: STUDY_DIRECTOR

Jaeb Center for Health Research

Katrina Ruedy, MSPH

Role: STUDY_DIRECTOR

Jaeb Center for Health Research

Philip Raskin, MD

Role: PRINCIPAL_INVESTIGATOR

UT Southwestern

Locations

Children's Hospital of Orange County (Pediatrics)

Orange, California, United States

University of California - San Diego (Adults)

San Diego, California, United States

Stanford University (Pediatrics and Adults)

Stanford, California, United States

Barbara Davis Center for Diabetes (Pediatrics and Adults)

Aurora, Colorado, United States

Children's National Health System (Pediatrics)

Washington D.C., District of Columbia, United States

Nemours Children's Clinic (Pediatrics)

Jacksonville, Florida, United States

Emory University (Pediatrics)

Atlanta, Georgia, United States

Massachusetts General Hospital - Diabetes Research Center (Peds and Adults)

Boston, Massachusetts, United States

Henry Ford Health System (Adults)

Detroit, Michigan, United States

Washington University (Adults)

St Louis, Missouri, United States

Naomi Berrie Diabetes Center at Columbia University (Pediatrics)

New York, New York, United States

University of Noth Carolina- Chapel Hill (Adults)

Chapel Hill, North Carolina, United States

Cleveland Clinic (Adults)

Cleveland, Ohio, United States

University of Texas- Southwestern (Pediatrics and Adults)

Dallas, Texas, United States

University of Texas Health Science Center (Pediatrics)

San Antonio, Texas, United States

University of Washington (Adults)

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 36173237 (View on PubMed)

Mauras N, Damiano ER, El-Khatib FH, Marak MC, Calhoun P, Ruedy KJ, Balliro C, Li Z, Beck RW, Russell SJ. Utility and Safety of Backup Insulin Regimens Generated by the Bionic Pancreas: A Randomized Study. Diabetes Technol Ther. 2023 Jun;25(6):437-441. doi: 10.1089/dia.2022.0461. Epub 2023 Mar 22.

Reference Type: BACKGROUND

PMID: 36877259 (View on PubMed)

Li Z, Calhoun P, Ruedy KJ, Beck RW. Concordance of Central Laboratory Hemoglobin A1c Measurements from Capillary Kits Compared to Venous Draws in the Insulin-Only Bionic Pancreas Pivotal Trial. Diabetes Technol Ther. 2023 Jul;25(7):513-515. doi: 10.1089/dia.2023.0094. Epub 2023 May 2.

Reference Type: BACKGROUND

PMID: 37053531 (View on PubMed)

Kruger D, Kass A, Lonier J, Pettus J, Raskin P, Salam M, Trikudanathan S, Zhou K, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Li Z, Marak MC, Calhoun P, Beck RW. A Multicenter Randomized Trial Evaluating the Insulin-Only Configuration of the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):697-711. doi: 10.1089/dia.2022.0200.

Reference Type: BACKGROUND

PMID: 36173236 (View on PubMed)

Beck RW, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Li Z, Calhoun P. A Multicenter Randomized Trial Evaluating Fast-Acting Insulin Aspart in the Bionic Pancreas in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):681-696. doi: 10.1089/dia.2022.0167.

Reference Type: BACKGROUND

PMID: 36173235 (View on PubMed)

Bionic Pancreas Research Group; Russell SJ, Beck RW, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro CA, Li Z, Calhoun P, Wadwa RP, Buckingham B, Zhou K, Daniels M, Raskin P, White PC, Lynch J, Pettus J, Hirsch IB, Goland R, Buse JB, Kruger D, Mauras N, Muir A, McGill JB, Cogen F, Weissberg-Benchell J, Sherwood JS, Castellanos LE, Hillard MA, Tuffaha M, Putman MS, Sands MY, Forlenza G, Slover R, Messer LH, Cobry E, Shah VN, Polsky S, Lal R, Ekhlaspour L, Hughes MS, Basina M, Hatipoglu B, Olansky L, Bhangoo A, Forghani N, Kashmiri H, Sutton F, Choudhary A, Penn J, Jafri R, Rayas M, Escaname E, Kerr C, Favela-Prezas R, Boeder S, Trikudanathan S, Williams KM, Leibel N, Kirkman MS, Bergamo K, Klein KR, Dostou JM, Machineni S, Young LA, Diner JC, Bhan A, Jones JK, Benson M, Bird K, Englert K, Permuy J, Cossen K, Felner E, Salam M, Silverstein JM, Adamson S, Cedeno A, Meighan S, Dauber A. Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. N Engl J Med. 2022 Sep 29;387(13):1161-1172. doi: 10.1056/NEJMoa2205225.

Reference Type: RESULT

PMID: 36170500 (View on PubMed)

Shapiro JB, Vesco AT, Carroll MS, Weissberg-Benchell J. Psychometric Properties of the Automated Insulin Delivery: Benefits and Burdens Scale for Adults with Type 1 Diabetes. Diabetes Technol Ther. 2024 Nov;26(11):842-850. doi: 10.1089/dia.2024.0117. Epub 2024 May 31.

Reference Type: DERIVED

PMID: 38758212 (View on PubMed)

Marak MC, Calhoun P, Damiano ER, Russell SJ, Ruedy KJ, Beck RW. Testing the Real-World Accuracy of the Dexcom G6 Pro CGM During the Insulin-Only Bionic Pancreas Pivotal Trial. Diabetes Technol Ther. 2023 Nov;25(11):817-821. doi: 10.1089/dia.2023.0287. Epub 2023 Oct 3.

Reference Type: DERIVED

PMID: 37668666 (View on PubMed)

Weissberg-Benchell J, Vesco AT, Shapiro J, Calhoun P, Damiano ER, Russell SJ, Li Z, El-Khatib FH, Ruedy KJ, Balliro CA, Beck RW. Psychosocial Impact of the Insulin-Only iLet Bionic Pancreas for Adults, Youth, and Caregivers of Youth with Type 1 Diabetes. Diabetes Technol Ther. 2023 Oct;25(10):705-717. doi: 10.1089/dia.2023.0238. Epub 2023 Sep 5.

Reference Type: DERIVED

PMID: 37523175 (View on PubMed)

Lynch J, Kanapka LG, Russell SJ, Damiano ER, El-Khatib FH, Ruedy KJ, Balliro C, Calhoun P, Beck RW. The Insulin-Only Bionic Pancreas Pivotal Trial Extension Study: A Multi-Center Single-Arm Evaluation of the Insulin-Only Configuration of the Bionic Pancreas in Adults and Youth with Type 1 Diabetes. Diabetes Technol Ther. 2022 Oct;24(10):726-736. doi: 10.1089/dia.2022.0341.

Reference Type: DERIVED

PMID: 36173238 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: RCT ICF

View Document

Document Type: Informed Consent Form: RCT Assent

View Document

Document Type: Informed Consent Form: BG Run iLet Ancillary Study ICF

View Document

Document Type: Informed Consent Form: BG Run iLet Ancillary Study Assent

View Document

Document Type: Informed Consent Form: Screening ICF and Assent

View Document

Document Type: Informed Consent Form: Test Run ICF and Assent

View Document

Other Identifiers

1UC4DK108612-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IOBPPT

Identifier Type: -

Identifier Source: org_study_id