Evidence map›Paper›PMID 27208316›Full record

Trial reportDiabetes care2016

Multinational Home Use of Closed-Loop Control Is Safe and Effective.

Stacey M Anderson, Dan Raghinaru, Jordan E Pinsker, Federico Boscari, Eric Renard, Bruce A Buckingham, Revital Nimri, Francis J Doyle, Sue A Brown, Patrick Keith-Hynes and 21 more

3 registry-linked trialsOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Diabetes care, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 1 pooled it
17.3field-weighted citation impact, top 1% 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.

NCT02137512 nacompletednot on this map

Pilot Study 3 of Outpatient Control-to-Range: Safety and Efficacy With Day-and-Night In-Home Use

TypeinterventionalSponsorJaeb Center for Health ResearchRan2014 to 2015Enrolled30ConditionsType 1 DiabetesArmsClosed-Loop Control System, Sensor-Augmented Pump (SAP)
NCT03212950 nacompletednot on this mapstarted 2017, after this paper: background citation

Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study

TypeinterventionalSponsorUniversity of Ljubljana, Faculty of MedicineRan2017 to 2017Enrolled20ConditionsType 1 Diabetes MellitusArmsFast-CL, Regular-CL
NCT07306364 phase2not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes

TypeinterventionalSponsorYale UniversityRan2026 to 2029Enrolled45ConditionsChronic Low Back Pain (CLBP), Physical Therapy, PsilocybinArmsPsilocybin 10 mg, Psilocybin 25 mg, Niacin 100 mg
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 1 synthesis or guideline pooled it, 117 citations in OpenAlex.

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  17. Review
  18. Artificial Pancreas: The First 20 Years.Journal of diabetes science and technology · 2025
    Article
  19. Early Stages of Automated Insulin Delivery.Journal of diabetes science and technology · 2025
    Review
  20. Early Stages of Automated Insulin Delivery.Diabetes technology & therapeutics · 2025
    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

31 authors at 11 institutions in 4 countries.

Stacey M AndersonUniversity of Virginia, Charlottesville, VA.
Dan RaghinaruJaeb Center for Health Research, Tampa, FL.
Jordan E PinskerWilliam Sansum Diabetes Center, Santa Barbara, CA.
Federico BoscariUniversity of Padova, Padova, Italy.
Eric RenardDepartment of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
Bruce A BuckinghamDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
Revital NimriJesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, and Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
Francis J DoyleDepartment of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
Sue A BrownUniversity of Virginia, Charlottesville, VA.
Patrick Keith-HynesUniversity of Virginia, Charlottesville, VA TypeZero Technologies, LLC, Charlottesville, VA.
Marc D BretonUniversity of Virginia, Charlottesville, VA.
Daniel ChernavvskyUniversity of Virginia, Charlottesville, VA.
Wendy C BevierWilliam Sansum Diabetes Center, Santa Barbara, CA.
Paige K BradleyWilliam Sansum Diabetes Center, Santa Barbara, CA.
Daniela BruttomessoUniversity of Padova, Padova, Italy.
Simone Del FaveroUniversity of Padova, Padova, Italy.
Roberta CaloreUniversity of Padova, Padova, Italy.
Claudio CobelliUniversity of Padova, Padova, Italy.
Angelo AvogaroUniversity of Padova, Padova, Italy.
Anne FarretDepartment of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
Jerome PlaceDepartment of Endocrinology, Diabetes, and Nutrition and INSERM 1411 Clinical Investigation Center, Montpellier University Hospital, and UMR CNRS 5203/INSERM U1191, Institute of Functional Genomics, University of Montpellier, Montpellier, France.
Trang T LyDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
Satya ShanmughamDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
Moshe PhillipJesse Z and Sara Lea Shafer Institute of Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, and Sackler Faculty of Medicine, Tel Aviv University, Petah Tikva, Israel.
Eyal DassauDepartment of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA Harvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.
Isuru S DasanayakeDepartment of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA.
Craig KollmanJaeb Center for Health Research, Tampa, FL.
John W LumJaeb Center for Health Research, Tampa, FL.
Roy W BeckJaeb Center for Health Research, Tampa, FL rbeck@jaeb.org.
Boris KovatchevUniversity of Virginia, Charlottesville, VA.
Control to Range Study Group
University of Padua · ITUniversity of Virginia · USJaeb Center for Health Research · USSansum Diabetes Research Institute · USStanford University · USCentre National de la Recherche Scientifique · FRHarvard University · USSchneider Children's Medical Center · ILTel Aviv University · ILUniversité de Montpellier · FRUniversity of California, Santa Barbara · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of a portable, wearable, wireless artificial pancreas system (the Diabetes Assistant [DiAs] running the Unified Safety System) on glucose control at home in overnight-only and 24/7 closed-loop control (CLC) modes in patients with type 1 diabetes. RESEARCH DESIGN AND

methodsAt six clinical centers in four countries, 30 participants 18-66 years old with type 1 diabetes (43% female, 96% non-Hispanic white, median type 1 diabetes duration 19 years, median A1C 7.3%) completed the study. The protocol included a 2-week baseline sensor-augmented pump (SAP) period followed by 2 weeks of overnight-only CLC and 2 weeks of 24/7 CLC at home. Glucose control during CLC was compared with the baseline SAP.

resultsGlycemic control parameters for overnight-only CLC were improved during the nighttime period compared with baseline for hypoglycemia (time <70 mg/dL, primary end point median 1.1% vs. 3.0%; P < 0.001), time in target (70-180 mg/dL: 75% vs. 61%; P < 0.001), and glucose variability (coefficient of variation: 30% vs. 36%; P < 0.001). Similar improvements for day/night combined were observed with 24/7 CLC compared with baseline: 1.7% vs. 4.1%, P < 0.001; 73% vs. 65%, P < 0.001; and 34% vs. 38%, P < 0.001, respectively.

conclusionsCLC running on a smartphone (DiAs) in the home environment was safe and effective. Overnight-only CLC reduced hypoglycemia and increased time in range overnight and increased time in range during the day; 24/7 CLC reduced hypoglycemia and increased time in range both overnight and during the day. Compared with overnight-only CLC, 24/7 CLC provided additional hypoglycemia protection during the day.

Indexed as

Insulin Infusion SystemsPancreas, ArtificialSmartphoneAdolescentAdultAgedBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleHumansHypoglycemiaHypoglycemic AgentsInsulinInternationalityMaleBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID27208316
PMCPMC5876016
OpenAlexW2335897113

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.