Evidence map›Paper›PMID 31338757›Full record

ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2019

Protocol of a Prospective Observational Study on the Relationship Between Glucose Fluctuation and Cardiovascular Events in Patients with Type 2 Diabetes.

Tomoya Mita, Naoto Katakami, Yosuke Okada, Hidenori Yoshii, Takeshi Osonoi, Keiko Nishida, Toshihiko Shiraiwa, Keiichi Torimoto, Akira Kurozumi, Satomi Wakasugi and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
1.9field-weighted citation impact, top 12% 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

15 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
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  11. The Role of Glycemic Variability in Cardiovascular Disorders.International journal of molecular sciences · 2021
    Review
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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

13 authors at 5 institutions in 1 country.

Tomoya MitaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, 2-1-1 Bunkyo-ku, Tokyo, Japan. tom-m@juntendo.ac.jp.ORCID http://orcid.org/0000-0002-4401-2965
Naoto KatakamiDepartment of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2,Yamadaoka, Suita, Osaka, Japan.
Yosuke OkadaFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Hidenori YoshiiDepartment of Medicine, Diabetology and Endocrinology, Juntendo Tokyo Koto Geriatric Medical Center, Shinsuna 3-3-20, Koto-ku, Tokyo, 136-0075, Japan.
Takeshi OsonoiNakakinen Clinic, 745-5, Nakadai, Naka City, Ibaraki, 311-0113, Japan.
Keiko NishidaNishida Keiko Diabetes Clinic, 1-3-26, Mitsusadadai, Yahatanishi-ku, Kitakyushu, Japan.
Toshihiko ShiraiwaShiraiwa Medical Clinic, 4-10-24 Houzenji, Kashiwara, Osaka, 582-0005, Japan.
Keiichi TorimotoFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Akira KurozumiFirst Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, 1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu, 807-8555, Japan.
Satomi WakasugiDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, 2-1-1 Bunkyo-ku, Tokyo, Japan.
Masahiko GoshoDepartment of Biostatistics, Faculty of Medicine, University of Tsukuba, 1-1-1,Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Iichiro ShimomuraDepartment of Metabolic Medicine, Osaka University Graduate School of Medicine, 2-2,Yamadaoka, Suita, Osaka, Japan.
Hirotaka WatadaDepartment of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine, 2-1-1 Bunkyo-ku, Tokyo, Japan.
Juntendo University · JPUniversity of Occupational and Environmental Health Japan · JPThe University of Osaka · JPKoto Hospital · JPUniversity of Tsukuba · JP

Funding

Manpei Suzuki Diabetes Foundation nonethe Japan Agency for Medical Research and Development none
6 · The paper itself

Abstract

introductionA recent study demonstrated that large glucose fluctuations were associated with an increased incidence of cardiovascular disease (CVD) in patients with type 2 diabetes mellitus (T2DM) and acute myocardial infarction. However, it is unknown whether glucose fluctuations are related to the incidence of CVD or the progression of atherosclerosis in patients with T2DM with no apparent history of CVD. In this protocol, we will be investigating the relationships of glucose fluctuations evaluated by continuous glucose monitoring (CGM) to the incidence of composite cardiovascular events and the progression of atherosclerosis in patients with T2DM who had no apparent history of CVD.

methodsThis is a prospective, multicenter, 5-year follow-up observational study. Between April 2018 and October 2019, 1000 participants are expected to be recruited at 34 medical institutions. CGM using FreeStyle Libre Pro is useful for evaluating glucose fluctuations by continuously monitoring glucose levels in interstitial fluid for up to 14 days. The primary study outcome is the relationship between fluctuations in glucose levels evaluated by CGM and the incidence of composite cardiovascular events. Secondary outcomes include the relationships of fluctuations in glucose levels evaluated by CGM to changes in carotid intima media thickness evaluated by echography or grayscale median (an index of tissue characteristics of the carotid wall), brachial-ankle pulse wave velocity, development or progression of diabetic retinopathy or nephropathy, quality-of-life-related diabetes therapy, quality of sleep, development of dementia, and autonomic nerve function. PLANNED OUTCOME: This protocol is designed to investigate the relationship between glucose fluctuations and the incidence of composite cardiovascular events. We completed the registration of 1000 participants in March 2019. Thus, results will be available in 2024. We expect that evaluating glucose fluctuations will aid the identification of patients with a high probability of developing CVD.

trial registrationClinicalTrials.gov identifier, UMIN000032325.

Indexed as

Cardiovascular diseaseContinuous glucose monitoringGlucose fluctuationProgression of atherosclerosisType 2 diabetes mellitus

Identifiers

PMID31338757
PMCPMC6778560
OpenAlexW2963995846

What OpenQuestion holds

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LicenceCC BY-NC
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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.