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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus Type 1 Diabetes Diabetes Mellitus, Type 1 | Device: Bionic Pancreas | Not Applicable |

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 |

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

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.
Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
- Clinical diagnosis of T1D for at least one year and using insulin for at least 1 year
- 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.
-
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.
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
-
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.
-
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

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
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 |
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 |
Documents provided by Jaeb Center for Health Research:
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 |
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 |
Artificial Pancreas Closed-loop Insulin Delivery |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Pancrelipase Gastrointestinal Agents |