The Insulin-Only Bionic Pancreas Pivotal Trial

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 1

In brief

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).

Key facts

Study ID

NCT04200313

Run by

Jaeb Center for Health Research

People needed

440

Starts

2020-03-31

Expected to finish

2022-01-14

Last updated by the study team

2025-02-20

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Age ≥ 6 years old
• Exception: the initial 5-participant test run will be limited to >18 years old
• Current use of a CGM, or if not a CGM user, at least 3 blood glucose meter tests daily on average over the last 4 weeks (according to judgment of investigator if meter is not available).
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia.
• For participants >18 years old who live alone, participant has a relative or acquaintance who lives within 30 minutes of participant and is willing to be contacted to check on participant if study staff feel that participant may be experiencing a medical emergency and can't be reached.
• Investigator believes that the participant can safely use the iLet and will follow the protocol
• The investigator will take into account the participant's HbA1c level, compliance with current diabetes management, and prior acute diabetic complications. For this reason, there is no upper limit on HbA1c specified for eligibility.
• If a GLP-1 agonist or pramlintide is being used, participant must be willing to discontinue use while the iLet BP system is being used, including the randomized trial and extension study.

You may not qualify if…

• 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:
• 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
• 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

Where it is running

• Children's Hospital of Orange County (Pediatrics) — Orange, California, United States
• University of California - San Diego (Adults) — San Diego, California, United States
• Stanford University (Pediatrics and Adults) — Stanford, California, United States
• Barbara Davis Center for Diabetes (Pediatrics and Adults) — Aurora, Colorado, United States
• Children's National Health System (Pediatrics) — Washington D.C., District of Columbia, United States
• Nemours Children's Clinic (Pediatrics) — Jacksonville, Florida, United States
• Emory University (Pediatrics) — Atlanta, Georgia, United States
• Massachusetts General Hospital - Diabetes Research Center (Peds and Adults) — Boston, Massachusetts, United States
• Henry Ford Health System (Adults) — Detroit, Michigan, United States
• Washington University (Adults) — St Louis, Missouri, United States
• Naomi Berrie Diabetes Center at Columbia University (Pediatrics) — New York, New York, United States
• University of Noth Carolina- Chapel Hill (Adults) — Chapel Hill, North Carolina, United States
• Cleveland Clinic (Adults) — Cleveland, Ohio, United States
• University of Texas- Southwestern (Pediatrics and Adults) — Dallas, Texas, United States
• University of Texas Health Science Center (Pediatrics) — San Antonio, Texas, United States
• University of Washington (Adults) — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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