Evidence map›Paper›PMID 31470740›Full record

Trial reportJournal of diabetes science and technology2019

Feasibility Studies of an Insulin-Only Bionic Pancreas in a Home-Use Setting.

Laya Ekhlaspour, Laura M Nally, Firas H El-Khatib, Trang T Ly, Paula Clinton, Eliana Frank, Molly L Tanenbaum, Sarah J Hanes, Rajendranath R Selagamsetty, Korey Hood and 2 more

Open access · bronzeAbstract readClinical Trial
In one paragraph

Trial report in Journal of diabetes science and technology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 20% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review of the OmnipodTherapeutic delivery · 2020
    Review
  5. Review
  6. Evolution of Insulin Delivery Devices: From Syringes, Pens, and Pumps to DIY Artificial Pancreas.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2020
    Review
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

12 authors at 3 institutions in 1 country.

Laya EkhlaspourDiabetes Unit, Massachusetts General Hospital, Boston, MA, USA.ORCID 0000-0002-3263-1419
Laura M NallyDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.ORCID 0000-0003-4349-4808
Firas H El-KhatibDepartment of Biomedical Engineering, Boston University, Boston, MA, USA.
Trang T LyDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.ORCID 0000-0002-5995-1447
Paula ClintonDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.
Eliana FrankDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.
Molly L TanenbaumDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.ORCID 0000-0003-4222-4224
Sarah J HanesDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.
Rajendranath R SelagamsettyDepartment of Biomedical Engineering, Boston University, Boston, MA, USA.
Korey HoodDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.
Edward R DamianoDepartment of Biomedical Engineering, Boston University, Boston, MA, USA.
Bruce A BuckinghamDivision of Pediatric Endocrinology and Diabetes, Stanford University School of Medicine, Palo Alto, CA, USA.
Stanford University · USBoston University · USMassachusetts General Hospital · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Training Research Leaders in Type 1 DiabetesK12DK122550 · NIDDK · STANFORD UNIVERSITY · PI MAAHS, DAVID MATTHEW · 2019 to 2023
$2.1M
NCATS NIH HHS UL1 TR001863NIDDK NIH HHS K12 DK122550
6 · The paper itself

Abstract

backgroundWe tested the safety and performance of the "insulin-only" configuration of the bionic pancreas (BP) closed-loop blood-glucose control system in a home-use setting to assess glycemic outcomes using different static and dynamic glucose set-points.

methodThis is an open-label non-randomized study with three consecutive intervention periods. Participants had consecutive weeks of usual care followed by the insulin-only BP with (1) an individualized static set-point of 115 or 130 mg/dL and (2) a dynamic set-point that automatically varied within 110 to 130 mg/dL, depending on hypoglycemic risk. Human factors (HF) testing was conducted using validated surveys. The last five days of each study arm were used for data analysis.

resultsThirteen participants were enrolled with a mean age of 28 years, mean A1c of 7.2%, and mean daily insulin dose of 0.6 U/kg (0.4-1.0 U/kg). The usual care arm had an average glucose of 145 ± 20 mg/dL, which increased in the static set-point arm (159 ± 8 mg/dL,

conclusionsThe insulin-only configuration of the BP using either static or dynamic set-points and initialized only with body weight performed similarly to other published insulin-only systems.

Indexed as

Blood GlucoseBlood Glucose Self-MonitoringAdultDiabetes Mellitus, Type 1Feasibility StudiesFemaleHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsMalePancreas, ArtificialTreatment OutcomeBlood GlucoseHypoglycemic AgentsInsulinartificial pancreasbionic pancreasclosed-loop systemtype 1 diabetes

Identifiers

PMID31470740
PMCPMC6835195
OpenAlexW2971110869

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.