Evidence map›Paper›PMID 35473359›Full record

Trial reportJournal of diabetes science and technology2023

Outcomes in Pump- and CGM-Baseline Use Subgroups in the International Diabetes Closed-Loop Trial.

Laya Ekhlaspour, Dan Raghinaru, Gregory P Forlenza, Elvira Isganaitis, Yogish C Kudva, David W Lam, Camilla Levister, Grenye O'Malley, Mei Mei Church, John W Lum and 2 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Journal of diabetes science and technology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 12% 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

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 15 citations in OpenAlex.

  1. Guideline
  2. Article
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Review
  9. Article
  10. A Systematic Review of Commercial Hybrid Closed-Loop Automated Insulin Delivery Systems.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2023 · on this map
    Review
  11. Article
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 8 institutions in 1 country.

Laya EkhlaspourDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.ORCID 0000-0002-3263-1419
Dan RaghinaruJaeb Center for Health Research, Tampa, FL, USA.
Gregory P ForlenzaBarbara Davis Center for Diabetes, Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.
Elvira IsganaitisResearch Division, Joslin Diabetes Center, Inc., Boston, MA, USA.
Yogish C KudvaDivision of Endocrinology, Diabetes, Metabolism and Nutrition, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.
David W LamDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Camilla LevisterDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Grenye O'MalleyDivision of Endocrinology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Mei Mei ChurchSansum Diabetes Research Institute, Santa Barbara, CA, USA.ORCID 0000-0003-3393-2042
John W LumJaeb Center for Health Research, Tampa, FL, USA.ORCID 0000-0002-0006-4376
Bruce BuckinghamDivision of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.ORCID 0000-0003-4581-4887
Sue A BrownUniversity of Virginia Center for Diabetes Technology, Charlottesville, VA, USA.
Icahn School of Medicine at Mount Sinai · USJaeb Center for Health Research · USStanford University · USJoslin Diabetes Center · USMayo Clinic in Arizona · USSansum Diabetes Research Institute · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Virginia · US

Funding

SPECIAL ASSAY COREP30DK036836 · NIDDK · JOSLIN DIABETES CENTER · PI Alessandro Doria · 1986 to 2026
$50.5M
Clinical Acceptance of the Artificial Pancreas: the International Diabetes Closed Loop (iDCL) TrialUC4DK108483 · NIDDK · UNIVERSITY OF VIRGINIA · PI ANDERSON, STACEY, DOYLE, FRANCIS J · 2016 to 2016
$12.7M
Modeling and modulating insulin delivery in automated insulin delivery systems to accommodate for meal compositionsK23DK121942 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI EKHLASPOUR, LAYA · 2020 to 2024
$964k
NIDDK NIH HHS K23 DK121942NIDDK NIH HHS P30 DK036836NIDDK NIH HHS UC4 DK108483
6 · The paper itself

Abstract

backgroundWe investigated the potential benefits of automated insulin delivery (AID) among individuals with type 1 diabetes (T1D) in sub-populations of baseline device use determined by continuous glucose monitor (CGM) use status and insulin delivery via multiple daily injections (MDI) or insulin pump. MATERIALS AND

methodsIn a six-month randomized, multicenter trial, 168 individuals were assigned to closed-loop control (CLC, Control-IQ, Tandem Diabetes Care), or sensor-augmented pump (SAP) therapy. The trial included a two- to eight-week run-in phase to train participants on study devices. The participants were stratified into four subgroups: insulin pump and CGM (pump+CGM), pump-only, MDI and CGM (MDI+CGM), and MDI users without CGM (MDI-only) users. We compared glycemic outcomes among four subgroups.

resultsAt baseline, 61% were pump+CGM users, 18% pump-only users, 10% MDI+CGM users, and 11% MDI-only users. Mean time in range 70-180 mg/dL (TIR) improved from baseline in the four subgroups using CLC: pump+CGM, 62% to 73%; pump-only, 61% to 70%; MDI+CGM, 54% to 68%; and MDI-only, 61% to 69%. The reduction in time below 70 mg/dL from baseline was comparable among the four subgroups. No interaction effect was detected with baseline device use for TIR (

conclusionsThere was a consistent benefit in patients with T1D when using CLC, regardless of baseline insulin delivery modality or CGM use. These data suggest that this CLC system can be considered across a wide range of patients.

Indexed as

Diabetes Mellitus, Type 1Blood GlucoseBlood Glucose Self-MonitoringHumansHypoglycemic AgentsInsulinInsulin Infusion SystemsInsulin, Regular, HumanBlood GlucoseHypoglycemic AgentsInsulinInsulin, Regular, Humanclosed-loop controlcontinuous glucose monitoringefficacyinsulin pumpmultiple daily injection

Identifiers

PMID35473359
PMCPMC10347978
OpenAlexW4224982653

What OpenQuestion 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 OpenQuestion graph.