Evidence map›Paper›PMID 33011923›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2020

Reduced Rates of Hypoglycemia in Type 1 or Type 2 Diabetes After Switching to Insulin Degludec: Results from the Italian Cohort of the ReFLeCT Study.

Gian Paolo Fadini, Carla Giordano, Laura Salvi, Antonio Nicolucci, REFLECT Italian Study Group

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02392117 (A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 39% 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.

NCT02392117 completednot on this map

A Multi-centre, Prospective, Non-interventional Study of Insulin Degludec Investigating the Safety and Effectiveness in a Real World Population With Type 1 and 2 Diabetes Mellitus

TypeobservationalSponsorNovo Nordisk A/SRan2015 to 2018Enrolled1,262ConditionsDiabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2Armsinsulin degludec
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 2 citations in OpenAlex.

No citing paper in PubMed yet.

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

5 authors at 4 institutions in 1 country.

Gian Paolo FadiniDepartment of Medicine, University of Padova, Padua, Italy. gianpaolo.fadini@unipd.it.ORCID http://orcid.org/0000-0002-6510-2097
Carla GiordanoSection of Endocrinology, Diabetology and Metabolism, Biomedical Department of Internal and Specialist Medicine (DIBIMIS), University of Palermo, Palermo, Italy.
Laura SalviNovo Nordisk Spa, Rome, Italy.
Antonio NicolucciThe Center for Outcomes Research and Clinical Epidemiology (CORESEARCH), Pescara, Italy.
REFLECT Italian Study Group
Center for Outcomes Research and Clinical Epidemiology · ITNovo Nordisk (Italy) · ITUniversity of Padua · ITUniversity of Palermo · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTo evaluate in an Italian real-world setting the safety and effectiveness of insulin degludec 100 units/mL, given once daily in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) after switching from other basal insulins.

methodsReFLeCT was a multicenter, prospective, observational study conducted across seven European countries which involved adult patients whose physician planned to switch their medication from basal insulin to insulin degludec. The primary outcome was the change in the number of hypoglycemic episodes before and after the switch to insulin degludec. Results are expressed as 12-month follow-up/baseline incidence rate ratios (IRRs) with 95% confidence intervals (95% CIs).

resultsThe Italian cohort of the ReFLect study comprised 148 patients with T1DM and 311 patients with T2DM. In patients with T1DM, the switch to insulin degludec was associated with significantly lower rates of overall (IRR 0.69, 95% CI 0.57-0.82), non-severe (IRR 0.72, 95% CI 0.60-0.85), and nocturnal hypoglycemia (IRR 0.46, 95% CI 0.31-0.69). Following the switch, hemoglobin A

conclusionIn Italian routine clinical practice, switching from other basal insulins to insulin degludec reduced the total episodes of hypoglycemia and improved glycemic control and treatment satisfaction in patients with T1DM and T2DM.

trial registrationClinicalTrials.gov NCT02392117.

Indexed as

HypoglycemiaInsulin degludecTreatment satisfactionType 1 diabetesType 2 diabetes

Identifiers

PMID33011923
PMCPMC7644665
OpenAlexW3091367244

What Socratic holds

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Registered trials

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.