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AzTrials

Diabetes MellitusNCT04200313

The Insulin-Only Bionic Pancreas Pivotal Trial

A study testing Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp) and BP Guidance Insulin Dosing in people with Diabetes Mellitus and Type 1 Diabetes, run by Jaeb Center for Health Research at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
What is being tested?
Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp) and BP Guidance Insulin Dosing
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
16 sitesUnited States
Study dates
31 Mar 2020to 14 Jan 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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:
  • 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
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  • 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
  • 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
  • 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

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Emory University (Pediatrics)

    Atlanta, Georgia, 30322

  • Barbara Davis Center for Diabetes (Pediatrics and Adults)

    Aurora, Colorado, 80045

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

    Boston, Massachusetts, 02114

  • University of Noth Carolina- Chapel Hill (Adults)

    Chapel Hill, North Carolina, 27517

  • Cleveland Clinic (Adults)

    Cleveland, Ohio, 44195

  • University of Texas- Southwestern (Pediatrics and Adults)

    Dallas, Texas, 75390

  • Henry Ford Health System (Adults)

    Detroit, Michigan, 48202

  • Nemours Children's Clinic (Pediatrics)

    Jacksonville, Florida, 32207

  • Naomi Berrie Diabetes Center at Columbia University (Pediatrics)

    New York, New York, 10032

  • Children's Hospital of Orange County (Pediatrics)

    Orange, California, 92868

  • University of Texas Health Science Center (Pediatrics)

    San Antonio, Texas, 78229

  • University of California - San Diego (Adults)

    San Diego, California, 92037

  • University of Washington (Adults)

    Seattle, Washington, 98109

  • Washington University (Adults)

    St Louis, Missouri, 63110

  • Stanford University (Pediatrics and Adults)

    Stanford, California, 94305

  • Children's National Health System (Pediatrics)

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: The Insulin-Only Bionic Pancreas Pivotal Trial: Testing the iLet in Adults and Children With Type 1 Diabetes

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).

Read the 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.
  • 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.

Being tested
Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp), Usual Care (UC), BP Guidance Insulin Dosing
Keywords
Artificial Pancreas, Closed-loop Insulin Delivery
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bionic Pancreas (BP) with Aspart or LisproCombination product

    Also called iLet

    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)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)Other

    Using pre-study insulin regimen with the Dexcom G6 CGM

  • BP Guidance Insulin DosingOther

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

Study groups in NCT04200313
Study groupRoleWhat they receive
Bionic Pancreas (BP)ExperimentalSome adults and 1/2 peds will be randomized to use the Bionic Pancreas (BP) with lispro or aspart for 13 weeks
Receives: Combination Product: Bionic Pancreas (BP) with Aspart or Lispro
Bionic Pancreas with Fiasp (BPFiasp)ExperimentalSome adults will be randomized to use the Bionic Pancreas (BP) with Fiasp for 13 weeks during RCT
Receives: Combination Product: Bionic Pancreas with Fiasp (BPFiasp)
Usual Care (UC)OtherAdults and peds will use their own diabetes insulin regimen plus continuous glucose monitoring (CGM) during the RCT
Receives: Other: Usual Care (UC)
Bionic Pancreas ExtensionExperimentalUsed by all participants in the EXT study
Receives: Combination Product: Bionic Pancreas (BP) with Aspart or Lispro; Combination Product: Bionic Pancreas with Fiasp (BPFiasp)
Transition Phase - BP GuidanceExperimentalAdults 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
Receives: Other: Usual Care (UC); Other: BP Guidance Insulin Dosing
Transition- Pre-study dosingOtherAdults 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
Receives: Other: Usual Care (UC)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 13 weeks

Secondary outcomes (45)

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

    The key secondary endpoint is CGM-measured time <54 mg/dL over 13 weeks

    Measured: 13 weeks

  2. CGM-measured Mean Glucose Level Over 13 Weeks

    Measured: 13 weeks

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

    Measured: 13 weeks

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

    Measured: 13 weeks

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

    Measured: 13 weeks

  6. CGM-measured Glucose Standard Deviation (SD) mg/dL Over 13 Weeks

    Measured: 13 weeks

  7. CGM-Measured Percentage Time <70 mg/dL Over 13 Weeks

    Measured: 13 weeks

  8. CGM-measured Percentage Time <54 mg/dL Over 13 Weeks

    Measured: 13 weeks

  9. CGM-Measured Glucose Coefficient of Variation Over 13 Weeks

    Measured: 13 weeks

  10. Other Secondary Efficacy Endpoint: HbA1c <7.0%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.0% at week 13. 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.

    Measured: 13 weeks

  11. Other Secondary Efficacy Endpoint: HbA1c <7.0% in Participants With Baseline HbA1c >7.5%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.0% at week 13 in participants with baseline HbA1c >7.5%. 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.

    Measured: 13 weeks

  12. Other Secondary Efficacy Endpoint: HbA1c <7.5%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <7.5% at week 13. 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.

    Measured: 13 weeks

  13. Other Secondary Efficacy Endpoint: HbA1c <8.0%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c <8.0% at week 13. 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.

    Measured: 13 weeks

  14. Other Secondary Efficacy Endpoint: HbA1c >9.0%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c >9.0% at week 13. 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.

    Measured: 13 weeks

  15. Other Secondary Efficacy Endpoint: HbA1c Improvement >0.5%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >0.5% from baseline to week 13. 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.

    Measured: 13 weeks

  16. Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >1.0% from baseline to week 13. 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.

    Measured: 13 weeks

  17. Other Secondary Efficacy Endpoint: HbA1c Relative Improvement >10%

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c relative improvement >10% from baseline to week 13. 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.

    Measured: 13 weeks

  18. Other Secondary Efficacy Endpoint: HbA1c Improvement >1.0% or HbA1c <7.0% at 13 Weeks

    Other Secondary Efficacy Endpoint: Central lab hemoglobin A1c improvement >1.0% from baseline to week 13 or central lab hemoglobin A1c <7.0% at week 13. 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.

    Measured: 13 weeks

  19. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-140 mg/dL Over 13 Weeks

    Measured: 13 weeks

  20. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-120 mg/dL Over 13 Weeks

    Measured: 13 weeks

  21. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <60 mg/dL Over 13 Weeks

    Measured: 13 weeks

  22. Other Secondary Efficacy Endpoint: CGM-measured Area Over the Curve 70 mg/dL Over 13 Weeks

    Area over the curve 70 mg/dL over the 13-week RCT period, measured as the mean of the differences between 70 mg/dL and CGM-measured glucose values below 70 mg/dL. For CGM-measured glucose values above 70 mg/dL, a value of 0 is used instead of the difference. For example, suppose a participant has 10 glucose readings of 78, 60, 59, 71, 80, 100, 110, 115, 120, and 118 mg/dL measured every 5 minutes. The distance between each reading below 70 mg/dL and 70 mg/dL is 0, 10, 11, 0, 0, 0, 0, 0, 0, and 0 mg/dL. The total area is 105 mg/dL*min; however, this value is then standardized by dividing by the length of time (50 min), resulting in a final CGM-measured area over the curve 70 mg/dL of 2.1 mg/dL.

    Measured: 13 weeks

  23. Other Secondary Efficacy Endpoint: Low Blood Glucose Index (LBGI)

    Other Secondary Efficacy Endpoint: CGM-measured low blood glucose index (LBGI) over 13 weeks. Ranges from 0 to 38.20, with higher values indicating more low CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome.

    Measured: 13 weeks

  24. Other Secondary Efficacy Endpoint: CGM-measured Hypoglycemic Events

    Other Secondary Efficacy Endpoint: CGM-measured hypoglycemic event (at least 15 consecutive minutes with a sensor reading <54 mg/dL) rate over 13 weeks

    Measured: 13 weeks

  25. Other Secondary Efficacy Endpoint: CGM-measured Hyperglycemic Events

    Other Secondary Efficacy Endpoint: CGM-measured hyperglycemic event (at least 90 minutes within a 120 minute period with a sensor reading >300 mg/dL) rate over 13 weeks

    Measured: 13 weeks

  26. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time >300 mg/dL Over 13 Weeks

    Measured: 13 weeks

  27. Other Secondary Efficacy Endpoint: CGM-measured Area Under the Curve 180 mg/dL Over 13 Weeks

    Area under the curve 180 mg/dL over the 13-week RCT period, measured as the mean of the differences between 180 mg/dL and CGM-measured glucose values above 180 mg/dL. For CGM-measured glucose values under 180 mg/dL, a value of 0 is used instead of the difference. For example, suppose a participant has 10 glucose readings of 100, 120, 182, 200, 250, 193, 179, 150, 140 and 118 mg/dL measured every 5 minutes. The distance between each reading above 180 mg/dL and 180 mg/dL is 0, 0, 2, 20, 70, 13, 0, 0, 0, and 0 mg/dL. The total area is 525 mg/dL*min; however, this value is then standardized by dividing by the length of time (50 min), resulting in a final CGM-measured area under the curve 180 mg/dL of 10.5 mg/dL.

    Measured: 13 weeks

  28. Other Secondary Efficacy Endpoint: High Blood Glucose Index (HBGI)

    Other Secondary Efficacy Endpoint: CGM-measured high blood glucose index (HBGI) over 13 weeks. Ranges from 0 to 57.27, with higher values indicating more high CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome.

    Measured: 13 weeks

  29. Other Secondary Efficacy Endpoint: Mean of Daily Difference in Mean Glucose

    Other Secondary Efficacy Endpoint: CGM-measured mean of daily difference in mean glucose over 13 weeks

    Measured: 13 weeks

  30. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time in Range 70-180 mg/dL >70% Over 13 Weeks

    Measured: 13 weeks

  31. Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%

    Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%

    Measured: 13 weeks

  32. Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%

    Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%

    Measured: 13 weeks

  33. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <70 mg/dL <4%

    Measured: 13 weeks

  34. Other Secondary Efficacy Endpoint: CGM-measured Percentage Time <54 mg/dL <1%

    Measured: 13 weeks

  35. Other Secondary Efficacy Endpoint: Blood Glucose Risk Index (LBGI + HBGI)

    Other Secondary Efficacy Endpoint: CGM-measured Blood Glucose Risk Index (LBGI + HBGI) over 13 weeks. Calculated as Low Blood Glucose Index (LBGI) + High Blood Glucose Index (HBGI). Ranges from 0 to 57.27, with higher values indicating more low or high CGM-measured glucose values over 13 weeks. Higher values are considered a worse outcome. LBGI and HBGI are inversely related: the presence of a high CGM-measured glucose reading removes an opportunity for a low glucose reading to exist and vice versa, therefore a maximum HBGI of 57.27 and a maximum LGBI of 38.20 cannot exist simultaneously. For instance, if a participant had glucose values of only 401 mg/dL, then the participant has no low glucose values, and therefore their HBGI = 57.27 and LBGI = 0. If a participant had only glucose values of 39 mg/dL, then the participant has no high glucose values, and therefore their HBGI = 0 and LBGI = 38.20. Consequently, the maximum blood glucose risk index is 57.27.

    Measured: 13 weeks

  36. Other Secondary Efficacy Endpoint: Improvement in HbA1c > 0.5% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without an Increase in HbA1c by > 0.5%

    Other Secondary Efficacy Endpoint: Baseline to week 13 improvement in central lab hemoglobin A1c >0.5% without an increase in CGM-measured percentage time <54 mg/dl by >0.5% OR improvement in CGM-measured percentage time <54 mg/dl by >0.5% without an increase in central lab hemoglobin A1c by >0.5%. 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.

    Measured: 13 weeks

  37. Other Secondary Efficacy Endpoint: Improvement in Time 70-180 mg/dl by >10% Without an Increase in Time < 54 mg/dl by > 0.5% OR Improvement in Time < 54 mg/dl by > 0.5% Without a Decrease in Time 70-180 mg/dl by > 10%

    Other Secondary Efficacy Endpoint: Baseline to 13-week improvement in CGM-measured percentage time 70-180 mg/dL by >10% without an increase in CGM-measured percentage time <54 mg/dL by >0.5% OR improvement in CGM-measured percentage time <54 mg/dL by >0.5% without a decrease in CGM-measured percentage time 70-180 mg/dL by >10%

    Measured: 13 weeks

  38. Other Secondary Efficacy Endpoint: Mean Glucose <154 mg/dL and Time <54 mg/dL <1%

    Other Secondary Efficacy Endpoint: CGM-measured mean glucose <154 mg/dL and percentage time <54 mg/dL <1% over 13 weeks

    Measured: 13 weeks

  39. Other Secondary Efficacy Endpoint: Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%

    Other Secondary Efficacy Endpoint: CGM-measured percentage time in range 70-180 mg/dL >70% and percentage time <54 mg/dL <1% over 13 weeks

    Measured: 13 weeks

  40. Other Secondary Efficacy Endpoint: Total Daily Insulin (Units/kg)

    Other Secondary Efficacy Endpoint: Total daily insulin (units/kg) from week 13 site-reported insulin data for the UC group and iLet pump device data over 13 weeks for the BP-A/L and BP-F groups.

    Measured: 13 weeks

  41. Other Secondary Efficacy Endpoint: Percentage Change in the TDD of Insulin Over the First Two-week Period Relative to the TDD of Insulin in the Last Two-week Period

    Other Secondary Efficacy Endpoint: Percentage change in the TDD of insulin over the first two-week period relative to the TDD of insulin in the last two-week period from iLet pump device data over 13 weeks for the BP-A/L and BP-F groups.

    Measured: Weeks 1-2 and weeks 12-13

  42. Other Secondary Efficacy Endpoint: Body Weight at Week 13

    Measured: 13 weeks

  43. Other Secondary Efficacy Endpoint: Body Mass Index (BMI) at Week 13

    Measured: 13 weeks

  44. Other Secondary Efficacy Endpoint: Mean Participant-reported Number of Hypoglycemic Events Requiring Carbohydrate Treatment Per 24 Hours

    Mean participant-reported number of hypoglycemic events requiring carbohydrate treatment per 24 hours, based on the responses to the question, 'How many times in the last 24 hours did you take carbohydrates to treat a low blood sugar?' administered to participants once weekly during the 13-week RCT period.

    Measured: 13 weeks

  45. Other Secondary Efficacy Endpoint: Mean Participant-reported Grams of Carbohydrate Taken Specifically to Prevent or Treat Hypoglycemic Events Per 24 Hours

    Mean participant-reported number of hypoglycemic events requiring carbohydrate treatment per 24 hours, based on the responses to the question, 'Estimate the total amount of grams of carbohydrates you were given to treat these low blood sugars', which is a follow-up question to 'How many times in the last 24 hours did you take carbohydrates to treat a low blood sugar?'. Both questions were administered to participants once weekly during the 13-week RCT period.

    Measured: 13 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2019
  2. Study start31 Mar 2020
  3. Primary completion30 Oct 2021
  4. Study completion14 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04200313
Sponsor's protocol ID
IOBPPT
Other IDs
1UC4DK108612-01
Status last verified
Feb 2025
First submitted
13 Dec 2019
Last updated
20 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 36173237

  • 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.

    PubMed 36877259

  • 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.

    PubMed 37053531

  • 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.

    PubMed 36173236

  • 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.

    PubMed 36173235

  • 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.

    PubMed 36170500

  • Bilionis I, Berrios RC, de Arriba Munoz A, Fernandez-Luque L, Castillo C. A framework for assessing algorithmic discrimination risks in training data: a case of pediatric type 1 diabetes. JAMIA Open. 2026 Jul 14;9(4):ooag125. doi: 10.1093/jamiaopen/ooag125. eCollection 2026 Aug.

    PubMed 42459945

  • 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.

    PubMed 38758212

  • 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.

    PubMed 37668666

  • 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.

    PubMed 37523175

  • 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.

    PubMed 36173238

Questions about this trial

What is this clinical trial studying?

A study testing Bionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp) and BP Guidance Insulin Dosing in people with Diabetes Mellitus and Type 1 Diabetes, run by Jaeb Center for Health Research at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c (time frame: 13 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04200313, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2025.

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