Evidence map›Paper›PMID 29652893›Full record

ArticlePloS one2018

Glucose sensor-augmented continuous subcutaneous insulin infusion in patients with diabetic gastroparesis: An open-label pilot prospective study.

Jorge Calles-Escandón, Kenneth L Koch, William L Hasler, Mark L Van Natta, Pankaj J Pasricha, James Tonascia, Henry P Parkman, Frank Hamilton, William H Herman, Marina Basina and 20 more

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Observational
  5. Review
  6. Review
  7. Review
  8. Concept analysis of diabetes-related quality of life.Health and quality of life outcomes · 2025
    Review
  9. Review
  10. Article
  11. Progress in Gastroparesis - A Narrative Review of the Work of the Gastroparesis Clinical Research Consortium.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Review
  12. Review
  13. Article
  14. Diabetic Gastroparesis: A Review.Diabetes spectrum : a publication of the American Diabetes Association · 2020
    Article
  15. Article
  16. Article
  17. Article
  18. Diabetic Gastroparesis and Glycaemic Control.Current diabetes reports · 2019
    Review
  19. Diabetic Gastroparesis.Endocrine reviews · 2019
    Review
  20. 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

30 authors at 12 institutions in 1 country.

Jorge Calles-EscandónEndocrinology Section, MetroHealth Regional, Case Western Reserve University, Cleveland, Ohio, United States of America.
Kenneth L KochSection on Gastroenterology, Wake Forest University, Winston-Salem, North Carolina, United States of America.
William L HaslerDivision of Gastroenterology, University of Michigan, Ann Arbor, Michigan, United States of America.ORCID 0000-0002-6158-2871
Mark L Van NattaDepartments of Biostatistics and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Pankaj J PasrichaSection of Gastroenterology, Johns Hopkins School of Medicine, Baltimore, Maryland, United States of America.
James TonasciaDepartments of Biostatistics and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Henry P ParkmanSection of Gastroenterology, Temple University School of Medicine, Philadelphia, Pennsylvania, United States of America.
Frank HamiltonNational Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland, United States of America.
William H HermanDivision of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan, United States of America.
Marina BasinaDivision of Pediatric Endocrinology, Stanford University School of Medicine, Palo Alto, California, United States of America.
Bruce BuckinghamDivision of Pediatric Endocrinology, Stanford University School of Medicine, Palo Alto, California, United States of America.
Karen EarleDivision of Endocrinology, California Pacific Medical Center, San Francisco, California, United States of America.
Kjersti KirkebyDivision of Endocrinology, California Pacific Medical Center, San Francisco, California, United States of America.
Kristen HairstonSection of Endocrinology, Wake Forest University, Winston-Salem, North Carolina, United States of America.
Tamis BrightDivision of Endocrinology, Diabetes, and Metabolism, Texas Tech University School of Medicine, El Paso, Texas, United States of America.
Amy E RothbergDivision of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan, United States of America.
Andrew T KraftsonDivision of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan, United States of America.
Elias S SirajSection of Endocrinology, Temple University School of Medicine, Philadelphia, Pennsylvania, United States of America.
Angela SubausteDivision of Endocrinology, University of Mississippi, Jackson, Mississippi, United States of America.
Linda A LeeSection of Gastroenterology, Johns Hopkins School of Medicine, Baltimore, Maryland, United States of America.
Thomas L AbellDivision of Gastroenterology, University of Louisville School of Medicine, Louisville, Kentucky, United States of America.
Richard W McCallumSection of Gastroenterology, Texas Tech University School of Medicine, El Paso, Texas, United States of America.
Irene SarosiekSection of Gastroenterology, Texas Tech University School of Medicine, El Paso, Texas, United States of America.
Linda NguyenDivision of Gastroenterology, Stanford University School of Medicine, Palo Alto, California, United States of America.
Ronnie FassGastroenterology Division, MetroHealth Regional, Case Western Reserve University, Cleveland, Ohio, United States of America.
William J SnapeDivision of Gastroenterology, California Pacific Medical Center, San Francisco, California, United States of America.
Ivana A VaughnDepartments of Biostatistics and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Laura A MirielDepartments of Biostatistics and Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Gianrico FarrugiaSection of Gastroenterology, Mayo Clinic, Rochester, Minnesota, United States of America.
NIDDK Gastroparesis Clinical Research Consortium (GpCRC)
Johns Hopkins University · USUniversity of Michigan · USCalifornia Pacific Medical Center · USStanford University · USTexas Tech University · USMetroHealth Medical Center · USTemple University · USWake Forest University · USMayo Clinic · USNational Institute of Diabetes and Digestive and Kidney Diseases · USUniversity of Louisville · USUniversity of Mississippi · US

Funding

Regional Pilot And Feasibility Study Grants ProgramP30DK020572 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Mehboob A Hussain · 2013 to 2026
$24.3M
Gastroparesis Consortium Continuation-Data Coordinating CenterU01DK074008 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI TONASCIA, JAMES A · 2006 to 2015
$17.4M
PGpR2 Year 4 Supplement for the Scientific Data Research Center (SDRC) of the GpCRC 4U24DK074008 · NIDDK · JOHNS HOPKINS UNIVERSITY · PI David M Shade · 2017 to 2026
$11.7M
Research BaseP30DK092926 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MARY ELLEN MICHELE HEISLER, ADESUWA B OLOMU · 2011 to 2026
$10.0M
Subtypes of GastroparesisU01DK073974 · NIDDK · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Baharak Moshiree · 2006 to 2026
$7.4M
Temple University Gastroparesis Clinical CenterU01DK073975 · NIDDK · TEMPLE UNIV OF THE COMMONWEALTH · PI HENRY PAUL PARKMAN · 2006 to 2026
$7.4M
U of L Clinical Center to Investigate the Pathogenesis, Etiology, and Treatment of Gastroparesis through the NIDDK Gastroparesis ConsortiumU01DK074007 · NIDDK · UNIVERSITY OF MISSISSIPPI MED CTR · PI Thomas Lyman Abell · 2006 to 2026
$7.0M
Molecular Approaches to Pathogenesis/Therapy in GastropaU01DK073983 · NIDDK · UNIVERSITY OF TEXAS MED BR GALVESTON · PI PANKAJ J PASRICHA · 2006 to 2026
$6.8M
The GpCRC Pediatric Gastroparesis Registry 2 (PGpR2): Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants with Symptoms of GastU01DK074035 · NIDDK · UNIVERSITY OF KANSAS MEDICAL CENTER · PI Irene Sarosiek · 2008 to 2026
$6.7M
New England Gastropareis Consortium: Neurobiology of GastroparesisU01DK112193 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Helen Burton Murray, Braden Kuo · 2016 to 2026
$4.8M
Visceral Afferent Dysfunction in Diabetic GastropathyU01DK073985 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI HASLER, WILLIAM L · 2006 to 2015
$2.7M
NIDDK NIH HHS P30 DK020572NIDDK NIH HHS P30 DK092926NIDDK NIH HHS U01 DK073974NIDDK NIH HHS U01 DK073975NIDDK NIH HHS U01 DK073983NIDDK NIH HHS U01 DK073985NIDDK NIH HHS U01 DK074007NIDDK NIH HHS U01 DK074008NIDDK NIH HHS U01 DK074035NIDDK NIH HHS U01 DK112193NIDDK NIH HHS U24 DK074008NIH HHS U01DK073974NIH HHS U01DK073975NIH HHS U01DK073983NIH HHS U01DK073985NIH HHS U01DK074007NIH HHS U01DK074008NIH HHS U01DK074035
6 · The paper itself

Abstract

Erratic blood glucose levels can be a cause and consequence of delayed gastric emptying in patients with diabetes. It is unknown if better glycemic control increases risks of hypoglycemia or improves hemoglobin A1c levels and gastrointestinal symptoms in diabetic gastroparesis. This study investigated the safety and potential efficacy of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) in poorly controlled diabetes with gastroparesis. Forty-five type 1 or 2 patients with diabetes and gastroparesis and hemoglobin A1c >8% from the NIDDK Gastroparesis Consortium enrolled in a 24 week open-label pilot prospective study of CSII plus CGM. The primary safety outcome was combined numbers of mild, moderate, and severe hypoglycemic events at screening and 24 weeks treatment. Secondary outcomes included glycemic excursions on CGM, hemoglobin A1c, gastroparesis symptoms, quality-of-life, and liquid meal tolerance. Combined mild, moderate, and severe hypoglycemic events occurred similarly during the screening/run-in (1.9/week) versus treatment (2.2/week) phases with a relative risk of 1.18 (95% CI 0.85-1.64, P = 0.33). CGM time in hypoglycemia (<70 mg/dL) decreased from 3.9% to 1.8% (P<0.0001), time in euglycemia (70-180 mg/dL) increased from 44.0% to 52.0% (P = 0.02), time in severe hyperglycemia (>300 mg/dL) decreased from 14.2% to 7.0% (P = 0.005), and hemoglobin A1c decreased from 9.4±1.4% to 8.3±1.3% (P = 0.001) on CSII plus CGM. Symptom scores decreased from 29.3±7.1 to 21.9±10.2 with lower nausea/vomiting, fullness/early satiety, and bloating/distention scores (P≤0.001). Quality-of-life scores improved from 2.4±1.1 to 3.1±1.1 (P<0.0001) and volumes of liquid nutrient meals tolerated increased from 420±258 to 487±312 mL (P = 0.05) at 24 weeks. In conclusion, CSII plus CGM appeared to be safe with minimal risks of hypoglycemic events and associated improvements in glycemic control, gastroparesis symptoms, quality-of-life, and meal tolerance in patients with poorly controlled diabetes and gastroparesis. This study supports the safety, feasibility, and potential benefits of improving glycemic control in diabetic gastroparesis.

Indexed as

Blood GlucoseDiabetes ComplicationsAdolescentAdultAgedFemaleGastroparesisHumansInfusions, SubcutaneousInsulinMaleMiddle AgedPilot ProjectsQuality of LifeSymptom AssessmentTreatment OutcomeBlood GlucoseInsulin

Identifiers

PMID29652893
PMCPMC5898706
OpenAlexW2805766648

What OpenQuestion holds

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Registered trials

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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.