Evidence map›Paper›PMID 36877259›Full record

Trial reportDiabetes technology & therapeutics2023

Utility and Safety of Backup Insulin Regimens Generated by the Bionic Pancreas: A Randomized Study.

Nelly Mauras, Edward R Damiano, Firas H El-Khatib, Martin Chase Marak, Peter Calhoun, Katrina J Ruedy, Courtney Balliro, Zoey Li, Roy W Beck, Steven J Russell

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes technology & therapeutics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04200313 (The Insulin-Only Bionic Pancreas Pivotal Trial), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04200313 nacompletednot on this map

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

TypeinterventionalSponsorJaeb Center for Health ResearchRan2020 to 2022Enrolled440ConditionsDiabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 1ArmsBionic Pancreas (BP) with Aspart or Lispro, Bionic Pancreas with Fiasp (BPFiasp), Usual Care (UC), BP Guidance Insulin Dosing
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Nelly MaurasDivision of Pediatric Endocrinology, Diabetes & Metabolism, Nemours Children's Health, Jacksonville, Florida, USA.ORCID 0000-0003-1175-3852
Edward R DamianoBeta Bionics, Concord, Massachusetts, USA.
Firas H El-KhatibBeta Bionics, Concord, Massachusetts, USA.
Martin Chase MarakJaeb Center for Health Research, Tampa, Florida, USA.
Peter CalhounJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5325-7200
Katrina J RuedyJaeb Center for Health Research, Tampa, Florida, USA.
Courtney BalliroBeta Bionics, Concord, Massachusetts, USA.
Zoey LiJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5950-9317
Roy W BeckJaeb Center for Health Research, Tampa, Florida, USA.ORCID 0000-0002-5194-8446
Steven J RussellBeta Bionics, Concord, Massachusetts, USA.

Funding

NIDDK NIH HHS UC4 DK108612
6 · The paper itself

Abstract

The bionic pancreas (BP) is initialized with body weight only and doses insulin autonomously without carbohydrate counting, instead using qualitative meal announcements. In case of device malfunction, the BP generates and continuously updates backup insulin doses for injection or pump users, including long-acting insulin dose, a four-period basal insulin profile, short-acting meal doses, and a glucose correction factor. Following a 13-week trial in type 1 diabetes, participants using the BP (6-83 years) completed 2-4 days, in which they were randomly assigned to their prestudy insulin regimen (

Indexed as

Diabetes Mellitus, Type 1Pancreas, ArtificialBionicsBlood GlucoseGlucoseHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsInsulin, Regular, HumanPancreasBlood GlucoseGlucoseHypoglycemic AgentsInsulinInsulin, Regular, HumanArtificial pancreasAutomated insulin deliveryBionic pancreasType 1 diabetes

Identifiers

PMID36877259
PMCPMC10398715

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.