Evidence map›Paper›PMID 29563196›Full record

Trial reportDiabetes care2018

Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia.

Eric D Foster, Nancy D Bridges, Irene D Feurer, Thomas L Eggerman, Lawrence G Hunsicker, Rodolfo Alejandro, Clinical Islet Transplantation Consortium

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Diabetes care, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 58 papers.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed
15.6field-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.

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

58 citing papers in PubMed, 118 citations in OpenAlex.

  1. Phase 3 trial of human islet-after-kidney transplantation in type 1 diabetes.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2021
    Trial
  2. Review
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Concept analysis of diabetes-related quality of life.Health and quality of life outcomes · 2025
    Review
  10. Article
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Review
  20. Validation of Igls Criteria for Islet Transplant Functional Status Using Person-Reported Outcome Measures in a Cross-Sectional Study.Transplant international : official journal of the European Society for Organ Transplantation · 2023
    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

7 authors at 4 institutions in 1 country.

Eric D FosterClinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA eric-foster@uiowa.edu.ORCID 0000-0002-1877-4595
Nancy D BridgesNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.
Irene D FeurerDepartments of Surgery and Biostatistics, Vanderbilt University Medical Center, and Vanderbilt Transplant Center, Nashville, TN.
Thomas L EggermanNational Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.
Lawrence G HunsickerClinical Trials Statistical and Data Management Center, Department of Biostatistics, University of Iowa, Iowa City, IA.
Rodolfo AlejandroDiabetes Research Institute, Miller School of Medicine, University of Miami, Miami, FL.ORCID 0000-0003-4387-5360
Clinical Islet Transplantation Consortium
National Institutes of Health · USUniversity of Iowa · USUniversity of Miami · USVanderbilt University Medical Center · US

Funding

Implementing a Maternal health and PRegnancy Outcomes Vision for Everyone (IMPROVE)UL1TR002378 · NCATS · EMORY UNIVERSITY · PI Andres J Garcia, Elizabeth O. Ofili · 2017 to 2026
$92.1M
Engaging University of California Stakeholders for Biorespository ResearchUL1TR000004 · NCATS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI GRANDIS, JENNIFER RUBIN · 2012 to 2015
$78.0M
Northwestern University Clinical and Translational Science Institute (NUCATS)UL1TR001422 · NCATS · NORTHWESTERN UNIVERSITY AT CHICAGO · PI D'AQUILA, RICHARD · 2015 to 2023
$56.8M
Continuation of Clin Islet Transplantation Consortium: Data Coordinating CenterU01DK070431 · NIDDK · UNIVERSITY OF IOWA · PI CLARKE, WILLIAM R. · 2004 to 2014
$54.8M
Institutional Clinical and Translational Science AwardUL1TR000003 · NCATS · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 2012 to 2015
$38.9M
University of Minnesota Clinical and Translational Science Institute (UMN CTSI)UL1TR000114 · NCATS · UNIVERSITY OF MINNESOTA · PI BLAZAR, BRUCE R · 2012 to 2015
$35.0M
YOUTH DRUG ABUSE, ADHD, AND RELATED DISRUPTIVE DISORDERSM01RR000400 · NCRR · UNIVERSITY OF MINNESOTA TWIN CITIES · PI KOTLYAR, MICHAEL · 1985 to 2009
$33.7M
Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
MULTIDISCIPLINARY CLINICAL AND TRANSLATIONAL SCIENCE (MCTS) PROGRAM (UL1)UL1RR025741 · NCRR · NORTHWESTERN UNIVERSITY AT CHICAGO · PI GREENLAND, PHILIP · 2008 to 2011
$24.7M
ZDV VS ZDV + DDL VS ZDV + DDL + NVP IN ASYMPTOMATIC HIV PATIENTSM01RR000040 · NCRR · UNIVERSITY OF PENNSYLVANIA · PI FITZGERALD, GARRET A · 1985 to 2006
$21.1M
Miami Clinical and Translational Science InstituteUL1TR000460 · NCATS · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI SACCO, RALPH L. · 2012 to 2016
$16.9M
Strategies to Improve Long Term Islet Graft SurvivalU01DK070460 · NIDDK · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI RICORDI, CAMILLO · 2004 to 2012
$11.6M
NCATS NIH HHS UL1 TR000003NCATS NIH HHS UL1 TR000004NCATS NIH HHS UL1 TR000050NCATS NIH HHS UL1 TR000114NCATS NIH HHS UL1 TR000150NCATS NIH HHS UL1 TR000454NCATS NIH HHS UL1 TR000460NCATS NIH HHS UL1 TR001422NCATS NIH HHS UL1 TR002378NCRR NIH HHS M01 RR000040NCRR NIH HHS M01 RR000400NCRR NIH HHS UL1 RR025741NIAID NIH HHS U01 AI065191NIAID NIH HHS U01 AI065192NIAID NIH HHS U01 AI065193NIAID NIH HHS U01 AI089316NIAID NIH HHS U01 AI089317NIDDK NIH HHS U01 DK070430NIDDK NIH HHS U01 DK070431NIDDK NIH HHS U01 DK070460NIDDK NIH HHS U01 DK085531
6 · The paper itself

Abstract

objectiveAttaining glycemic targets without severe hypoglycemic events (SHEs) is a challenging treatment goal for patients with type 1 diabetes complicated by impaired awareness of hypoglycemia (IAH). The CIT Consortium Protocol 07 (CIT-07) trial showed islet transplantation to be an effective treatment for subjects with IAH and intractable SHEs. We evaluated health-related quality of life (HRQOL), functional health status, and health utility before and after pancreatic islet transplantation in CIT-07 trial participants. RESEARCH DESIGN AND

methodsFour surveys, the Diabetes Distress Scale (DDS), the Hypoglycemic Fear Survey (HFS), the Short Form 36 Health Survey (SF-36), and the EuroQoL 5 Dimensions (EQ-5D), were administered repeatedly before and after islet transplantation. Summary statistics and longitudinal modeling were used to describe changes in survey scores from baseline and to characterize change in relation to a minimally important difference (MID) threshold of half an SD.

resultsImprovements in condition-specific HRQOL met the MID threshold. Reductions from baseline in the DDS total score and its four DDS subscales (all

conclusionsIn CIT-07, 87.5% of the subjects achieved the primary end point of freedom from SHE along with glycemic control (HbA

Indexed as

Health StatusIslets of Langerhans TransplantationQuality of LifeAdultBlood GlucoseDiabetes Mellitus, Type 1FemaleFollow-Up StudiesHumansHypoglycemiaHypoglycemic AgentsMaleMiddle AgedSeverity of Illness IndexSurveys and QuestionnairesTreatment OutcomeBlood GlucoseHypoglycemic Agents

Identifiers

PMID29563196
PMCPMC5911786
OpenAlexW2790698710

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.