Evidence mapPaperPMID 31865633Full record

Trial reportDiabetes, obesity & metabolism2020

Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study.

George Grunberger, Anuj Bhargava, Trang Ly, Howard Zisser, Liza L Ilag, James Malone, Ludi Fan, Shuyu Zhang, Jennal Johnson

Open access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
3.5field-weighted citation impact, top 6% 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

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Trial
  6. Article
  7. A Mini-Patch Magnetic Insulin Pump for Enhanced Delivery Resolution and Accuracy.Advanced intelligent systems (Weinheim an der Bergstrasse, Germany) · 2026
    Article
  8. Insulin Pumps for Individuals With Type 2 Diabetes.Diabetes spectrum : a publication of the American Diabetes Association · 2025
    Article
  9. Review
  10. Article
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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

9 authors at 4 institutions in 1 country.

George GrunbergerGrunberger Diabetes Institute, Bloomfield Hills, Michigan, United States.ORCID 0000-0003-2431-0532
Anuj BhargavaIowa Diabetes and Endocrinology Research Center, West Des Moines, Iowa, United States.
Trang LyInsulet Corporation, 100 Nagog Park, Acton, Massachusetts, United States.
Howard ZisserVerily Life Sciences, San Francisco, California, United States.
Liza L IlagEli Lilly and Company, Indianapolis, Indiana, United States.
James MaloneEli Lilly and Company, Indianapolis, Indiana, United States.
Ludi FanEli Lilly and Company, Indianapolis, Indiana, United States.
Shuyu ZhangEli Lilly and Company, Indianapolis, Indiana, United States.
Jennal JohnsonEli Lilly and Company, Indianapolis, Indiana, United States.
Eli Lilly (United States) · USGrunberger Diabetes Institute · USInsulet (United States) · USIowa Diabetes and Endocrinology Research Center · US

Funding

American Diabetes AssociationEli Lilly and CompanyInsulet Corporation
6 · The paper itself

Abstract

aimTo compare the safety and efficacy of U500-R delivered by a novel, specifically designed U500-R insulin pump with U-500R delivered by multiple daily injections (MDI).

methodsThe phase 3 VIVID study randomized people with type 2 diabetes to U-500R by continuous subcutaneous insulin infusion (CSII) or MDI. Participants (aged 18-85 years) had HbA1c ≥7.5% and ≤12.0% and a total daily dose of insulin >200 and ≤600 U/day. After a 2-week transition to three times daily injections of U-500R, participants were treated for 24 weeks with U-500R by CSII or MDI. Treatment arms were compared using mixed model repeated measures analysis.

resultsThe study randomized 420 participants (CSII: 209, MDI: 211) with 365 completers. Mean changes from baseline were: HbA1c, -1.27% (-13.9 mmol/mol) with CSII and -0.85% (-9.3 mmol/mol) with MDI (difference - 0.42% [-4.6 mmol/mol], P <0.001); fasting plasma glucose, -33.9 mg/dL (-1.9 mmol/L) with CSII and 1.7 mg/dL (0.09 mmol/L) with MDI (difference - 35.6 mg/dL [-2.0 mmol/L], P <0.001); total daily dose, 2.8 U with CSII and 51.3 U with MDI (P < 0.001). Weight changes and rates of documented symptomatic and severe hypoglycaemia were similar between groups; the CSII group had a higher rate of nocturnal hypoglycaemia.

conclusionsIn type 2 diabetes requiring high doses of insulin, both methods of U-500R delivery lowered HbA1c. However, the CSII group attained greater HbA1c reduction with significantly less insulin. Individualized dose titration will be important to balance glycaemic control with hypoglycaemia risk.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2AdultBlood GlucoseGlycated HemoglobinHumansHypoglycemic AgentsInjections, SubcutaneousInsulinInsulin Infusion SystemsBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulinclinical trialcontinuous subcutaneous insulin infusioninsulin resistanceinsulin therapyrandomized trialtype 2 diabetes.

Identifiers

PMID31865633
PMCPMC7065168
OpenAlexW2996374979

What Socratic holds

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LicenceCC BY-NC-ND
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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 Socratic graph.