Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (48 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2019-07-23, after 2019-03-19 start.
Reason given by the sponsor: “other”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2019-07-23. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: coronaryarterytype diabetesepisodenon
Phrases that lowered it: subjectsparticipantsafety ofprescriptionabnormal -
Sponsor's past termination rate: 14.6% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Design: crossover (lowers risk) · Design
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Drug's FAERS reports marked serious: 53.2% (lowers risk) · Drug's FDA history
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Sponsor's past trials: 842 (raises risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Blinding: single (lowers risk) · Design
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Drug's FAERS reports with a death: 5.1% (lowers risk) · Drug's FDA history
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Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 192 (lowers risk) · Sponsor's track record
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Drug's FAERS reports before start: 124005 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2/3 (typical: 2)
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 5 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 842 (typical: 32)
- Sponsor's past termination rate
- 14.6% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 192 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 124005 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 18272 (typical: 412.5)
- Drug's FAERS reports marked serious
- 53.2% (typical: 85.6%)
- Drug's FAERS reports with a death
- 5.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- insulin aspart, insulin lispro
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- The Insulin-Only Bionic Pancreas Bridging Study NCT03565666 · started 2018 · scored riskier than 54% of active trials completed
- The Bihormonal iLet Bionic Pancreas Feasibility Study NCT03840278 · started 2019 · scored riskier than 65% of active trials completed
- GPR119 Agonist for Hypoglycemia in Type 1 Diabetes NCT04432090 · started 2021 · scored riskier than 6% of active trials completed
- Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone NCT00797823 · started 2008 · scored riskier than 35% of active trials completed
- Three Way Crossover Closed Loop Study With Xeris Glucagon NCT03424044 · started 2018 · scored riskier than 19% of active trials completed
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.