The Insulin-Only Bionic Pancreas Pivotal Trial

NCT04200313 | Completed Results DMC FDA Device

• 2 other identifiers: IOBPPT1UC4DK108612-01
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 16

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).

Conditions

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

Keywords

Artificial Pancreas; Closed-loop Insulin Delivery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (45)

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

  13 weeks

• CGM-measured Mean Glucose Level Over 13 Weeks

  13 weeks

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

  13 weeks

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

  13 weeks

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

  13 weeks

Other Outcomes (4)

• Safety Outcome Measure: Severe Hypoglycemia Events

  13 weeks

• Safety Outcome Measure: Diabetic Ketoacidosis Events

  13 weeks

• Safety Outcome Measure: Other Serious Adverse Events

  13 weeks

Study Arms (6)

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

Other: Usual Care (UC); Other: BP Guidance Insulin Dosing

Transition- Pre-study dosing

OTHER

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

Other: Usual Care (UC)

Interventions

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.

Also known as: iLet

Bionic Pancreas (BP); Bionic Pancreas Extension

Bionic Pancreas with Fiasp (BPFiasp) 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.

Bionic Pancreas Extension; Bionic Pancreas with Fiasp (BPFiasp)

Usual Care (UC) OTHER

Using pre-study insulin regimen with the Dexcom G6 CGM

Transition Phase - BP Guidance; Transition- Pre-study dosing; Usual Care (UC)

BP Guidance Insulin Dosing OTHER

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

Transition Phase - BP Guidance

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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
• \. Age ≥ 6 years old
• Exception: the initial 5-participant test run will be limited to \>18 years old
• \. 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).
• \. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• \. For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Beta Bionics, Inc.: collaborator
• Boston University: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (16)

Children's Hospital of Orange County (Pediatrics)

Orange, California, 92868, United States

Location

University of California - San Diego (Adults)

San Diego, California, 92037, United States

Location

Stanford University (Pediatrics and Adults)

Stanford, California, 94305, United States

Location

Barbara Davis Center for Diabetes (Pediatrics and Adults)

Aurora, Colorado, 80045, United States

Location

Children's National Health System (Pediatrics)

Washington D.C., District of Columbia, 20010, United States

Location

Nemours Children's Clinic (Pediatrics)

Jacksonville, Florida, 32207, United States

Location

Emory University (Pediatrics)

Atlanta, Georgia, 30322, United States

Location

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

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System (Adults)

Detroit, Michigan, 48202, United States

Location

Washington University (Adults)

St Louis, Missouri, 63110, United States

Location

Naomi Berrie Diabetes Center at Columbia University (Pediatrics)

New York, New York, 10032, United States

Location

University of Noth Carolina- Chapel Hill (Adults)

Chapel Hill, North Carolina, 27517, United States

Location

Cleveland Clinic (Adults)

Cleveland, Ohio, 44195, United States

Location

University of Texas- Southwestern (Pediatrics and Adults)

Dallas, Texas, 75390, United States

Location

University of Texas Health Science Center (Pediatrics)

San Antonio, Texas, 78229, United States

Location

University of Washington (Adults)

Seattle, Washington, 98109, United States

Location

Related Publications (10)

• 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.

  PMID: 36173237 BACKGROUND

• 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.

  PMID: 36877259 BACKGROUND

• 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.

  PMID: 37053531 BACKGROUND

• 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.

  PMID: 36173236 BACKGROUND

• 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.

  PMID: 36173235 BACKGROUND

• 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.

  PMID: 36170500 RESULT

• 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.

  PMID: 38758212 DERIVED

• 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.

  PMID: 37668666 DERIVED

• 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.

  PMID: 37523175 DERIVED

• 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.

  PMID: 36173238 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1

Interventions

Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Katrina Ruedy
• Organization: Jaeb Center for Health Research

kruedy@jaeb.org

813-975-8690

Study Officials

• 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

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jeremy Pettus, MD

  UC-San Diego

  PRINCIPAL INVESTIGATOR

• John Buse, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Irl Hirsch, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Jane Lynch, MD

  UT Health Science Center - San Antonio

  PRINCIPAL INVESTIGATOR

• Perrin White, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Janet McGill, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

• Jill Weissberg-Benchell, PhD

  Lurie Children's Hospital

  PRINCIPAL INVESTIGATOR

• Roy Beck, MD, PhD

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Katrina Ruedy, MSPH

  Jaeb Center for Health Research

  STUDY DIRECTOR

• Philip Raskin, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 16, 2019
• Study Start: March 31, 2020
• Primary Completion: October 30, 2021
• Study Completion: January 14, 2022
• Last Updated: February 20, 2025
• Results First Posted: November 7, 2023

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)