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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200313
Recruitment Status : Active, not recruiting
First Posted : December 16, 2019
Last Update Posted : February 9, 2021
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

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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 : August 30, 2021
Estimated Study Completion Date : December 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

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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


Locations
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United States, California
Children's Hospital of Orange County (Pediatrics)
Orange, California, United States, 92868
University of California - San Diego (Adults)
San Diego, California, United States, 92037
Stanford University (Pediatrics and Adults)
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Diabetes (Pediatrics and Adults)
Aurora, Colorado, United States, 80045
United States, District of Columbia
Children's National Health System (Pediatrics)
Washington, District of Columbia, United States, 20010
United States, Florida
Nemours Children's Clinic (Pediatrics)
Jacksonville, Florida, United States, 32207
United States, Georgia
Emory University (Pediatrics)
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Massachusetts General Hospital - Diabetes Research Center (Peds and Adults)
Boston, Massachusetts, United States, 02114
United States, Michigan
Henry Ford Health System (Adults)
Detroit, Michigan, United States, 48202
United States, Missouri
Washington University (Adults)
Saint Louis, Missouri, United States, 63110
United States, New York
Naomi Berrie Diabetes Center at Columbia University (Pediatrics)
New York, New York, United States, 10032
United States, North Carolina
University of Noth Carolina- Chapel Hill (Adults)
Chapel Hill, North Carolina, United States, 27517
United States, Ohio
Cleveland Clinic (Adults)
Cleveland, Ohio, United States, 44195
United States, Texas
University of Texas- Southwestern (Pediatrics and Adults)
Dallas, Texas, United States, 75390
University of Texas Health Science Center (Pediatrics)
San Antonio, Texas, United States, 78229
United States, Washington
University of Washington (Adults)
Seattle, Washington, United States, 98109
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
  Study Documents (Full-Text)

Documents provided by Jaeb Center for Health Research:
Informed Consent Form: Screening ICF  [PDF] March 13, 2020
Informed Consent Form: Screening Assent  [PDF] November 1, 2019
Informed Consent Form: Test Run ICF  [PDF] October 6, 2020
Informed Consent Form: Test Run Assent  [PDF] August 12, 2020

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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: February 9, 2021
Last Verified: February 2021
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
Pancrelipase
Gastrointestinal Agents