Evidence map›Paper›PMID 31937608›Full record

Trial reportDiabetes care2020

Randomized Controlled Trial of Mobile Closed-Loop Control.

Boris Kovatchev, Stacey M Anderson, Dan Raghinaru, Yogish C Kudva, Lori M Laffel, Carol Levy, Jordan E Pinsker, R Paul Wadwa, Bruce Buckingham, Francis J Doyle and 11 more

Erratum issued 2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Diabetes care, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 3 pooled it
–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.

NCT02985866 nacompletednot on this map

Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) Trial: A Randomized Clinical Trial to Assess the Efficacy of Adjunctive Closed Loop Control Versus Sensor-Augmented Pump Therapy in the Management of Type 1 Diabetes

TypeinterventionalSponsorUniversity of VirginiaRan2017 to 2018Enrolled127ConditionsType1 Diabetes MellitusArmsArtificial Pancreas, Sensor Augmented Therapy
NCT05653518 narecruitingnot on this mapstarted 2023, after this paper: background citation

Using Closed-Loop Artificial Pancreas Technology to Reduce Glycemic Variability and Subsequently Improve Cardiovascular Health in Type 1 Diabetes

TypeinterventionalSponsorUniversity of VirginiaRan2023 to 2027Enrolled40ConditionsType 1 DiabetesArmsTandem t:slim X2 with Control-IQ Technology, Sensor augmented pump (SAP) therapy
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Article
  8. Article
  9. Early Stages of Automated Insulin Delivery.Diabetes technology & therapeutics · 2025
    Review
  10. Early Stages of Automated Insulin Delivery.Journal of diabetes science and technology · 2025
    Review
  11. Article
  12. Review
  13. Article
  14. Article
  15. Review
  16. Review
  17. Article
  18. Review
  19. Real-World User and Clinician Perspective and Experience with MiniMed™ 780G Advanced Hybrid Closed Loop System.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023
    Article
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

21 authors.

Boris KovatchevCenter for Diabetes Technology, University of Virginia, Charlottesville, VA.
Stacey M AndersonDivision of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA.
Dan RaghinaruJaeb Center for Health Research, Tampa, FL.
Yogish C KudvaDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.ORCID 0000-0003-0285-6622
Lori M LaffelJoslin Diabetes Center, Harvard Medical School, Boston, MA.ORCID 0000-0002-9675-3001
Carol LevyDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY.
Jordan E PinskerSansum Diabetes Research Institute, Santa Barbara, CA.ORCID 0000-0003-4080-9034
R Paul WadwaBarbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO.
Bruce BuckinghamDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.
Francis J DoyleHarvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.ORCID 0000-0002-3293-9114
Sue A BrownDivision of Endocrinology and Metabolism, Department of Medicine, University of Virginia, Charlottesville, VA.
Mei Mei ChurchSansum Diabetes Research Institute, Santa Barbara, CA.
Vikash DadlaniDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN.
Eyal DassauHarvard John A. Paulson School of Engineering and Applied Sciences, Harvard University, Cambridge, MA.ORCID 0000-0001-5333-6892
Laya EkhlaspourDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA.ORCID 0000-0002-3263-1419
Gregory P ForlenzaBarbara Davis Center for Diabetes, University of Colorado, Anschutz Medical Campus, Aurora, CO.ORCID 0000-0003-3607-9788
Elvira IsganaitisJoslin Diabetes Center, Harvard Medical School, Boston, MA.
David W LamDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY.
John LumJaeb Center for Health Research, Tampa, FL jl_manuscripts@jaeb.org.ORCID 0000-0002-0006-4376
Roy W Beck
iDCL Study Group

Funding

PILOT STUDY--SECRETORY TARGETING IN PANCREATIC B CELLSP30DK036836 · JOSLIN DIABETES CENTER · 1986 to 2025
$12.1M
Training Research Leaders in Type 1 DiabetesK12DK122550 · NIDDK · STANFORD UNIVERSITY · PI David Matthew Maahs · 2023 to 2023
$649k
NIDDK NIH HHS K12 DK122550NIDDK NIH HHS P30 DK036836NIDDK NIH HHS UC4 DK108483
6 · The paper itself

Abstract

objectiveAssess the efficacy of inControl AP, a mobile closed-loop control (CLC) system. RESEARCH DESIGN AND

methodsThis protocol, NCT02985866, is a 3-month parallel-group, multicenter, randomized unblinded trial designed to compare mobile CLC with sensor-augmented pump (SAP) therapy. Eligibility criteria were type 1 diabetes for at least 1 year, use of insulin pumps for at least 6 months, age ≥14 years, and baseline HbA

resultsBetween November 2017 and May 2018, 127 participants were randomly assigned 1:1 to CLC (

conclusionsIn meeting its coprimary end points, superiority of CLC over SAP in CGM-measured time below 3.9 mmol/L and noninferiority in CGM-measured time above 10 mmol/L, the study has demonstrated that mobile CLC is feasible and could offer certain usability advantages over embedded systems, provided the connectivity between system components is stable.

Indexed as

Insulin Infusion SystemsAdolescentAdultAgedBiosensing TechniquesBlood GlucoseBlood Glucose Self-MonitoringDiabetes Mellitus, Type 1FemaleHumansHypoglycemic AgentsInsulinInsulin, Regular, HumanMaleMiddle AgedMobile ApplicationsBlood GlucoseHypoglycemic AgentsInsulinInsulin, Regular, Human

Identifiers

PMID31937608
PMCPMC7035585

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.