Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone
Model scores of the 29,894 trials active now.
Model score 14% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (220 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2009-09-30, after 2008-11-30 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2009-09-30. 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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Sponsor's past termination rate: 100% (raises risk) · Sponsor's track record
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: cellpriorsmallchronicgreater than
Phrases that lowered it: topicaltypeinvestigatormultipleabuse -
Design: crossover (lowers risk) · Design
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Accepts healthy volunteers: No (raises risk) · Who can join
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Drug's FAERS reports marked serious: 56.5% (lowers risk) · Drug's FDA history
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Minimum age: 21 (lowers risk) · Who can join
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Blinding: single (lowers risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Trials the sponsor started in the prior 2 years: 1 (raises risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Drug's FAERS reports with a death: 4.4% (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 3619 (raises risk) · Drug's FDA history
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Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
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Number of arms: 3 (lowers risk) · Design
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Responsible party: principal investigator (lowers risk) · Design
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Maximum age: 65 (lowers risk) · Who can join
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
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- single (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 2 (typical: 0)
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 21 (typical: 18)
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 2 (typical: 32)
- Sponsor's past termination rate
- 100% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 1 (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
- 3619 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1080 (typical: 412.5)
- Drug's FAERS reports marked serious
- 56.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, immunology, endocrine
- Drugs matched to FDA substances
- glucagon, glucagon like peptide, insulin aspart
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
- Individualizing Automated Closed Loop Glucose Control Through Pharmacokinetic Profiling in an Insulin-Only Bionic Pancreas NCT03262116 · started 2019 · scored riskier than 44% of active trials terminated
- Three Way Crossover Closed Loop Study With Xeris Glucagon NCT03424044 · started 2018 · scored riskier than 19% of active trials completed
- 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
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.