Evidence mapPaperPMID 32118347Full record

Trial reportDiabetes/metabolism research and reviews2020

Comparable efficacy with similarly low risk of hypoglycaemia in patient- vs physician-managed basal insulin initiation and titration in insulin-naïve type 2 diabetic subjects: The Italian Titration Approach Study.

Riccardo C Bonadonna, Andrea Giaccari, Raffaella Buzzetti, Gianluca Perseghin, Domenico Cucinotta, Angelo Avogaro, Gianluca Aimaretti, Monica Larosa, Carmine G Fanelli, Geremia B Bolli

Open access · hybridAbstract readClinical Trial, Phase IVComparative StudyMulticenter Study
In one paragraph

Trial report in Diabetes/metabolism research and reviews, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. Article
  7. Observational
  8. Article
  9. Article
  10. 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

10 authors at 9 institutions in 2 countries.

Riccardo C BonadonnaDivision of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma Italy, Parma, Italy.ORCID 0000-0002-9809-1005
Andrea GiaccariFondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy.ORCID 0000-0002-7462-7792
Raffaella BuzzettiSapienza University of Rome, Rome, Italy.ORCID 0000-0003-1490-6041
Gianluca PerseghinUniversity of Milan Bicocca, Milan, Italy.
Domenico CucinottaUniversity of Messina, Messina, Italy.
Angelo AvogaroUniversity of Padua, Padova, Italy.
Gianluca AimarettiUniversity of the Eastern Piedmont, Vercelli, Italy.
Monica LarosaSanofi, Milan, Italy.
Carmine G FanelliSection of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.
Geremia B BolliSection of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.
University of Perugia · ITSanofi (Italy) · ITSapienza University of Rome · ITUniversità Cattolica del Sacro Cuore · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity of Messina · ITUniversity of Milano-Bicocca · ITUniversity of Padua · ITUniversity of Parma · IT

Funding

Sanofi, Milan, Italy
6 · The paper itself

Abstract

aimsPeople with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM. MATERIALS AND

methodsITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA

resultsThree hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA

conclusionsIn the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.

Indexed as

AdolescentAdultAgedAged, 80 and overBiomarkersBlood GlucoseDiabetes Mellitus, Type 2FemaleFollow-Up StudiesGlycated HemoglobinGlycemic ControlHumansHypoglycemiaHypoglycemic AgentsIncidenceInsulinBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic AgentsInsulinglargine 300 U/mLglycaemic controlhypoglycaemiainsulin analoguespersonalized medicinerandomized trialtype 2 diabetes

Identifiers

PMID32118347
PMCPMC7540052
OpenAlexW3010059674

What Socratic holds

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LicenceCC BY
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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 Socratic graph.