An interventional study of Bihormonal Bionic Pancreas in Hyperinsulinism, Diabetes and Pancreatic Diseases, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 6 Years to 30 Years. Per ClinicalTrials.gov, last updated 2020-10-27.
Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment
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Among 56 studies in Hyperinsulinism with a site in United States — 14 open to participants now, 17 under way, 2 of them phase 3. Hyperinsulinism · United States.
Among the 56 studies in Hyperinsulinism with a site in United States, this one is the 38th largest by enrollment of the 46 interventional ones that give a count, is one of 3 that started in 2018, is one of 14 with no phase, and was the 27th registered.
112 studies on the registry are indexed under Hyperinsulinism; 24 are open to participants now.
Browse Hyperinsulinism studies →14 of the 56 studies in Hyperinsulinism with a site in United States are open now. Recruiting first, the newest first:
Columbia University · Sites in United States
Ages 18–70 · Healthy volunteers
Columbia University · Sites in United States
Ages 18–65
Rezolute · Sites in United States, France, Netherlands and 2 more countries
Ages 18+
Yale University · Sites in United States
Ages 18+ · Women only
Columbia University · Sites in United States
Ages 18–70 · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 18 Hyperinsulinism studies recruiting now, 5 (28%) set no upper age limit and 11 (61%) stop at 75 or younger; 5 take children under 18; 8 take healthy volunteers.
This study: 6 Years to 30 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
56 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 19 · Phase 2 13 · Phase 3 4 · Phase 4 1
First in 1995; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 10 is below the median of 29 across 79 interventional studies indexed under Hyperinsulinism.
Median enrollment 23 across the 46 interventional studies, 150 across the 7 observational. Of the 33 that completed or were terminated, 14 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
2 of 56 have an industry lead sponsor. The 10 most frequent:
Children's Hospital of Philadelphia is the lead sponsor of 489 studies on the registry; 90 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 22 (79%) have results posted.
Children's Hospital of Philadelphia has 8 studies filed under Hyperinsulinism — fewer than ten, so there is no comparison to draw.
5 of the studies in Hyperinsulinism with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06881992Phase 3RezoluteA Phase 3 Study of Ersodetug in Patients With Tumor Hyperinsulinism | 2027-09 |
| NCT05455619SynDevRx, Inc.Evexomostat Plus PI3K or AKT Inhibitor and Fulvestrant in Patients With a PI3K Alteration and HR+/Her2- Breast Cancer | 2026-12 |
| NCT03374215National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks | 2026-12-31 |
| NCT06354088Columbia UniversityHuman Models of Selective Insulin Resistance: Alpelisib, Part I | 2026-12-31 |
| NCT05950282Ali ChappellDeterminants of Insulin Sensitivity by Age, Sex, Race/Ethnicity, BMI, and PCOS Diagnosis | 2027-10 |
Add all 5 to your calendar (.ics) → With an account.
Among the 56 studies in Hyperinsulinism with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after having a pancreatectomy.
The management of diabetes following pancreatectomy for hyperinsulinism (HI) generally consists of the same approaches that are used for individuals with type 1 diabetes (T1D). However, there are significant differences in individuals with HI and post-pancreatectomy diabetes that increases the risk of hypoglycemia in these individuals and prevent achieving tight glycemic control. Individuals with HI have glucagon deficiency and unlike T1D, those with HI and post-pancreatectomy diabetes have residual dysregulated insulin secretion that results in marked hypo- and hyper-glycemia. Furthermore, pancreatic insufficiency can result in disturbances in nutrient absorption and fluctuations in glucose concentrations.
Current treatment approaches with intermittent subcutaneous insulin administration or insulin pump therapy offer inadequate glycemic control in these individuals. We propose a novel approach to the management of these individuals with the bihormonal bionic pancreas to replace both hormones, insulin and glucagon, through an automated glycemic management system.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Diabetes confirmed by one or more of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Four day inpatient admission where participants will have blood sugar managed by the Bihormonal Bionic Pancreas. Blood sugars will be monitored for safety by study staff.
Device: Bihormonal Bionic Pancreas
Four day inpatient admission where participants will have blood sugar managed by the participant's home-glucose control regimen. Blood sugars will be monitored for safety by study staff.
A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
Mean Plasma Glucose Level.
Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 2 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
Time frame: Days 2-3 of each admission
| Milestone | Bihormonal Bionic Pancreas Admission | Standard Care Admission |
|---|---|---|
| Started | 5 | 5 |
| Washout | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
Mean plasma glucose concentration, as measured by the Continuous glucose monitoring system (CGMS), during the final 2 days of the Bihormonal Bionic Pancreas Admission compared to the Standard Care Admission.
| mg/dL | Sequential Admissions |
|---|---|
| Bihormonal Bionic Pancreas Admission | 149.666118 ± 12.7998623 |
| Standard Care Admision | 162.574753 ± 32.2642656 |
Collected over Adverse event data was collected from the start of screening until the end of the last day of the subject's second admission. This time period ranged from 16 to 38 days, depending on how many days in between admissions they had.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bihormonal Bionic Pancreas Admission | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Standard Care Admission | 0/5 (0%) | 0/5 (0%) | 5/5 (100%) |
| Event | Bihormonal Bionic Pancreas Admission | Standard Care Admission |
|---|---|---|
| Intermittent nasueaGastrointestinal disorders | 2/5 | 3/5 |
| HeadacheNervous system disorders | 0/5 | 3/5 |
| HyperglycemiaMetabolism and nutrition disorders | 0/5 | 1/5 |
| Upper respiratory infectionInfections and infestations | 0/5 | 1/5 |
| Age, Continuous(years) | Sequential Admissions |
|---|---|
| Mean | 15.1 (7 to 25) |
| Sex: Female, Male(Participants) | Sequential Admissions |
|---|---|
| Female | 5 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Sequential Admissions |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 10 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Sequential Admissions |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 9 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Sequential Admissions |
|---|---|
| United States | 10 |
| Mean Plasma Glucose Level(mmmol/L) | Sequential Admissions |
|---|---|
| Bionic Pancreas Admission | 8.3 ± 0.7 |
| Standard Care Admission | 9.0 ± 1.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Sep 2019, 17 months.
Results were first posted in Oct 2020, 1 year after primary completion.
Of 24 interventional studies with no phase under Hyperinsulinism, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 90. This study's 17 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Philadelphia →