Evidence map›Paper›PMID 24929429›Full record

Trial reportDiabetes care2014

Safety of outpatient closed-loop control: first randomized crossover trials of a wearable artificial pancreas.

Boris P Kovatchev, Eric Renard, Claudio Cobelli, Howard C Zisser, Patrick Keith-Hynes, Stacey M Anderson, Sue A Brown, Daniel R Chernavvsky, Marc D Breton, Lloyd B Mize and 13 more

Registry-linked trialOpen access · hybridAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01714505 (Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy), which is not on this map. Cited by 81 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
81citing papers in PubMed, 2 pooled it
21.5field-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.

NCT01714505 nacompletednot on this map

Early Feasibility Study 2 of Outpatient Control-to-Range - Testing System Efficacy

TypeinterventionalSponsorUniversity of VirginiaRan2012 to 2013Enrolled20ConditionsDiabetes Mellitus, Type 1ArmsDiabetes Assistant (DiAs)
3 · Its place in the literature

Who cites it

81 citing papers in PubMed, 2 syntheses or guidelines pooled it, 177 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. Trial
  15. Trial
  16. Trial
  17. Trial
  18. Trial
  19. Home Use of an Artificial Beta Cell in Type 1 Diabetes.The New England journal of medicine · 2015
    Trial
  20. Trial

21 more citing papers are in PubMed but not listed here.

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

23 authors at 8 institutions in 3 countries.

Boris P KovatchevCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA boris@virginia.edu.
Eric RenardDepartment of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Center 1001, Institute of Functional Genomics, CNRS UMR 5203, INSERM U661, University of Montpellier 1, Montpellier, France.
Claudio CobelliDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Howard C ZisserSansum Diabetes Research Institute, Santa Barbara, CA.
Patrick Keith-HynesCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Stacey M AndersonCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Sue A BrownCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Daniel R ChernavvskyCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Marc D BretonCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Lloyd B MizeCenter for Diabetes Technology and Department of Medicine, Division of Endocrinology, University of Virginia, Charlottesville, VA.
Anne FarretDepartment of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Center 1001, Institute of Functional Genomics, CNRS UMR 5203, INSERM U661, University of Montpellier 1, Montpellier, France.
Jérôme PlaceDepartment of Endocrinology, Diabetes, and Nutrition, Montpellier University Hospital, INSERM Clinical Investigation Center 1001, Institute of Functional Genomics, CNRS UMR 5203, INSERM U661, University of Montpellier 1, Montpellier, France.
Daniela BruttomessoDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Simone Del FaveroDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Federico BoscariDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Silvia GalassoDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Angelo AvogaroDepartment of Information Engineering and Department of Internal Medicine, Unit of Metabolic Disease, University of Padova, Padova, Italy.
Lalo MagniDepartment of Systems Engineering, University of Pavia, Pavia, Italy.
Federico Di PalmaDepartment of Systems Engineering, University of Pavia, Pavia, Italy.
Chiara ToffaninDepartment of Systems Engineering, University of Pavia, Pavia, Italy.
Mirko MessoriDepartment of Systems Engineering, University of Pavia, Pavia, Italy.
Eyal DassauDepartment of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA.
Francis J DoyleDepartment of Chemical Engineering, University of California, Santa Barbara, Santa Barbara, CA.
University of Virginia · USUniversity of Padua · ITUniversity of Pavia · ITUniversity of California, Santa Barbara · USCentre National de la Recherche Scientifique · FRInserm · FRSansum Diabetes Research Institute · USUniversité de Montpellier · FR

Funding

Personalized Fully-Automated Regulation and Co-Regulation of Type 1 Diabetes: A Foundation Biobehavioral ApproachR01DK085623 · NIDDK · UNIVERSITY OF VIRGINIA · PI SUE A BROWN, BORIS P KOVATCHEV · 2009 to 2026
$10.6M
NIDDK NIH HHS R01 DK085623NIDDK NIH HHS R01-DK-085623
6 · The paper itself

Abstract

objectiveWe estimate the effect size of hypoglycemia risk reduction on closed-loop control (CLC) versus open-loop (OL) sensor-augmented insulin pump therapy in supervised outpatient setting. RESEARCH DESIGN AND

methodsTwenty patients with type 1 diabetes initiated the study at the Universities of Virginia, Padova, and Montpellier and Sansum Diabetes Research Institute; 18 completed the entire protocol. Each patient participated in two 40-h outpatient sessions, CLC versus OL, in randomized order. Sensor (Dexcom G4) and insulin pump (Tandem t:slim) were connected to Diabetes Assistant (DiAs)-a smartphone artificial pancreas platform. The patient operated the system through the DiAs user interface during both CLC and OL; study personnel supervised on site and monitored DiAs remotely. There were no dietary restrictions; 45-min walks in town and restaurant dinners were included in both CLC and OL; alcohol was permitted.

resultsThe primary outcome-reduction in risk for hypoglycemia as measured by the low blood glucose (BG) index (LGBI)-resulted in an effect size of 0.64, P = 0.003, with a twofold reduction of hypoglycemia requiring carbohydrate treatment: 1.2 vs. 2.4 episodes/session on CLC versus OL (P = 0.02). This was accompanied by a slight decrease in percentage of time in the target range of 3.9-10 mmol/L (66.1 vs. 70.7%) and increase in mean BG (8.9 vs. 8.4 mmol/L; P = 0.04) on CLC versus OL.

conclusionsCLC running on a smartphone (DiAs) in outpatient conditions reduced hypoglycemia and hypoglycemia treatments when compared with sensor-augmented pump therapy. This was accompanied by marginal increase in average glycemia resulting from a possible overemphasis on hypoglycemia safety.

Indexed as

Pancreas, ArtificialAdultBlood GlucoseBlood Glucose Self-MonitoringCell PhoneCross-Over StudiesDiabetes Mellitus, Type 1FemaleHumansHypoglycemiaHypoglycemic AgentsInsulinInsulin Infusion SystemsMaleMiddle AgedOutpatientsBlood GlucoseHypoglycemic AgentsInsulin

Identifiers

PMID24929429
PMCPMC4067397
OpenAlexW2134076472

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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 OpenQuestion graph.