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The Insulin-Only Bionic Pancreas Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200313
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : April 7, 2020
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Beta Bionics, Inc.
Boston University
Massachusetts General Hospital
Information provided by (Responsible Party):
Jaeb Center for Health Research

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 System for 3 months. At the completion of use of the BP system (end of RCT for BP Group and end of Extension Phase for UC Group), 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Diabetes Diabetes Mellitus, Type 1 Device: Bionic Pancreas Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes
Actual Study Start Date : March 31, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: Bionic Pancreas (BP)
Adults and peds will use the Bionic Pancreas (BP) with lispro or aspart for 13 weeks
Device: Bionic Pancreas
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.
Other Name: iLet

Experimental: Bionic Pancreas with Fiasp (BPFiasp)
Adults will use the Bionic Pancreas (BP) with Fiasp for 13 weeks
Device: Bionic Pancreas
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.
Other Name: iLet

No Intervention: Usual Care (UC)
Adults and peds will use their own diabetes regimen



Primary Outcome Measures :
  1. HbA1c [ Time Frame: HbA1c will be taken at baseline, 6 weeks and 13 weeks ]
    Superiority for HbA1c at 13 weeks will be considered the primary endpoint.


Secondary Outcome Measures :
  1. CGM time <54mg/dL (key secondary endpoint) [ Time Frame: 13 weeks ]
    based on sensor glucose ata



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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.

      8. 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:

Inclusion

  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. 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.

  8. 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. Renal failure on dialysis or with an eGFR <30mL/min

    • If eGFR is not available within the last 12 months, it must be obtained as part of usual care in order 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200313


Contacts
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Contact: Katrina Ruedy, MSPH 813-975-8690 kruedy@jaeb.org
Contact: Jaeb Center for Heatlh Research 813-975-8690

Locations
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United States, California
Children's Hospital of Orange County (Pediatrics) Recruiting
Orange, California, United States, 92868
Contact: Heather Speer, MPH, CDE    714-509-8613    HSpeer@choc.org   
Principal Investigator: Mark Daniels, MD         
Sub-Investigator: Amrit Bhangoo, MD         
Sub-Investigator: Nikta Forghani, MD         
Sub-Investigator: Himala Kashmiri, MD         
University of California - San Diego (Adults) Recruiting
San Diego, California, United States, 92037
Contact: Todd May, MS    858-246-2169    tmay@ucsd.edu   
Principal Investigator: Jeremy Pettus, MD         
Sub-Investigator: Shafer Boeder, MD         
Sub-Investigator: Vala Hamidi, MD         
Stanford University (Pediatrics and Adults) Recruiting
Stanford, California, United States, 94305
Contact: Liana Hsu, BS    650-725-3939    ljhsu@stanford.edu   
Principal Investigator: Bruce A Buckingham, MD         
Sub-Investigator: Lisa Norlander, MD         
Sub-Investigator: Laya Ekhlaspour, MD         
United States, Colorado
Barbara Davis Center for Diabetes (Pediatrics and Adults) Recruiting
Aurora, Colorado, United States, 80045
Contact: Emily Jost, RD, CDE, CSSD    (303)724-7313    emily.jost@ucdenver.edu   
Principal Investigator: Robert Slover, MD         
Principal Investigator: Paul Wadwa, MD         
Sub-Investigator: Gregory Forlenza, MD         
Sub-Investigator: Erin Cobry, MD         
United States, District of Columbia
Children's National Health System (Pediatrics) Recruiting
Washington, District of Columbia, United States, 20010
Contact: Kimberly Boucher    202-476-1403    kboucher@childrensnational.org   
Principal Investigator: Fran Cogen, MD         
Sub-Investigator: Seema Meighan, NP         
United States, Florida
Nemours Children's Clinic (Pediatrics) Recruiting
Jacksonville, Florida, United States, 32207
Contact: Keisha Bird, NP, PhD    904-697-3122    keisha.bird@nemours.org   
Principal Investigator: Nelly Mauras, MD         
Sub-Investigator: Matthew Benson, MD         
Sub-Investigator: Joe Permuy, NP         
Sub-Investigator: Keisha Bird, NP, PhD         
United States, Georgia
Emory University (Pediatrics) Recruiting
Atlanta, Georgia, United States, 30322
Contact: Chloe Shay    404-712-4125    chloe.shay@emory.edu   
Principal Investigator: Andrew Muir, MD         
Sub-Investigator: Nina Ham, MD         
Sub-Investigator: Kristina Cossen, MD         
Sub-Investigator: Eric Felner, MD         
United States, Massachusetts
Massachusetts General Hospital - Diabetes Research Center (Peds and Adults) Recruiting
Boston, Massachusetts, United States, 02114
Contact: Courtney Balliro, RN, CDE    617-726-1242    cballiro@partners.org   
Principal Investigator: Steven J Russell, MD         
Sub-Investigator: Jordan Sherwood, MD         
Sub-Investigator: Luz Castellanos, MD         
Sub-Investigator: Marwa Tuffaha, MD         
Sub-Investigator: Mallory Hillard, NP         
United States, Michigan
Henry Ford Health System (Adults) Recruiting
Detroit, Michigan, United States, 48202
Contact: Terra Cushman    313-916-3906    Tcushma1@hfhs.org   
Principal Investigator: Davida Kruger, NP         
Sub-Investigator: Arti Bhan, MD         
United States, Missouri
Washington University (Adults) Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Mary J Clifton    314-362-8681    mclifton@wustl.edu   
Principal Investigator: Janet McGill, MD         
Sub-Investigator: Maamoun Salam, MD         
Sub-Investigator: Aswathi Kumar, MD         
Sub-Investigator: Henry Zelada, MD         
United States, New York
Naomi Berrie Diabetes Center at Columbia University (Pediatrics) Recruiting
New York, New York, United States, 10032
Contact: Sarah Pollak    212-851-5425    sjp2174@columbia.edu   
Principal Investigator: Robin Goland, MD         
Sub-Investigator: Rachel Gandica, MD         
Sub-Investigator: Kristen Williams, MD         
Sub-Investigator: Natasha Leibel, MD         
United States, North Carolina
University of Noth Carolina- Chapel Hill (Adults) Recruiting
Chapel Hill, North Carolina, United States, 27517
Contact: Alex Kass, RN, CDE    984-974-3002    alex_kass@med.unc.edu   
Principal Investigator: John Buse, MD         
Sub-Investigator: Sue Kirkman, MD         
Sub-Investigator: Katherine Bergamo, FNP         
Sub-Investigator: Klara Klein, MD         
Sub-Investigator: Jean Marie Dostou, MD         
Sub-Investigator: Sriram Machineni, MD         
United States, Ohio
Cleveland Clinic (Adults) Recruiting
Cleveland, Ohio, United States, 44195
Contact: Ana Surckla, RN    216-444-3955    asurckla@ccf.org   
Principal Investigator: Betul Hatipoglu, MD         
Sub-Investigator: Diane Isaacs, MD         
United States, Texas
University of Texas- Southwestern (Pediatrics and Adults) Recruiting
Dallas, Texas, United States, 75390
Contact: Lin Jordan, RN    214-648-3473    lin.fan@utsouthwestern.edu   
Contact: Michael Henson    (214)-648-2017    Michael.Henson@childrens.com   
Principal Investigator: Perrin While, MD         
Principal Investigator: Philip Raskin, MD         
University of Texas Health Science Center (Pediatrics) Recruiting
San Antonio, Texas, United States, 78229
Contact: Dana Word, RN    210-562-5875    Word@uthscsa.edu   
Principal Investigator: Jane Lynch, MD         
Sub-Investigator: Rabab Jafri, MD         
Sub-Investigator: Maria Rayas, MD         
Sub-Investigator: Ella Escaname, MD         
Sub-Investigator: Carisse Orsi, MD         
Sub-Investigator: Gary Francis, MD         
Sub-Investigator: Ruby Favela-Prezas, FNP         
United States, Washington
University of Washington (Adults) Recruiting
Seattle, Washington, United States, 98109
Contact: Nancy Sanborn, ND, CDE    206-221-7179    nsanborn@uw.edu   
Principal Investigator: Irl Hirsch, MD         
Sub-Investigator: Subbulaxmi Trikudanathan, MD         
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Beta Bionics, Inc.
Boston University
Massachusetts General Hospital
Investigators
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Principal Investigator: 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 Health System
Principal Investigator: Betul Hatipoglu, 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
Study Director: Roy Beck, MD, PhD Jaeb Center for Health Research
Study Director: Katrina Ruedy, MSPH Jaeb Center for Health Research
Principal Investigator: Philip Raskin, MD UT Southwestern

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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT04200313    
Other Study ID Numbers: IOBPPT
1UC4DK108612-01 ( U.S. NIH Grant/Contract )
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Jaeb Center for Health Research:
Artificial Pancreas
Closed-loop Insulin Delivery
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Pancrelipase
Pancreatin
Hypoglycemic Agents
Physiological Effects of Drugs
Gastrointestinal Agents