Long-term cost-effectiveness of implementing a lifestyle intervention during pregnancy to reduce the incidence of gestational diabetes and type 2 diabetes

Melanie Lloyd1,2 iD Jedidiah Morton1,2,3 ● Helena Teede2 ● Clara Marquina1 ● Dina Abushanab1 ● Dianna J. Magliano2,3 ● Emily J. Callander2 ● Zanfina Ademi1,2

Received: 25 August 2022 /Accepted: 31 January 2023 © The Author(s) 2023

Abstract

Aims/hypothesis The aim of this study was to determine the long-term cost-effectiveness and return on investment of implementing a structured lifestyle intervention to reduce excessive gestational weight gain and associated incidence of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus.

Methods A decision-analytic Markov model was used to compare the health and cost-effectiveness outcomes for (1) a structured lifestyle intervention during pregnancy to prevent GDM and subsequent type 2 diabetes; and (2) current usual antenatal care. Life table modelling was used to capture type 2 diabetes morbidity, mortality and quality-adjusted life years over a lifetime horizon for all women giving birth in Australia. Costs incorporated both healthcare and societal perspectives. The intervention effect was derived from published meta-analyses. Deterministic and probabilistic sensitivity analyses were used to capture the impact of uncertainty in the model.

Results The model projected a 10% reduction in the number of women subsequently diagnosed with type 2 diabetes through implementation of the lifestyle intervention compared with current usual care. The total net incremental cost of intervention was approximately AU$70 million, and the cost savings from the reduction in costs of antenatal care for GDM, birth complications and type 2 diabetes management were approximately AU$85 million. The intervention was dominant (cost-saving) compared with usual care from a healthcare perspective, and returned AU$1.22 (95% CI 0.53, 2.13) per dollar invested. The results were robust to sensitivity analysis, and remained cost-saving or highly cost-effective in each of the scenarios explored.

Conclusions/interpretation This study demonstrates significant cost savings from implementation of a structured lifestyle intervention during pregnancy, due to a reduction in adverse health outcomes for women during both the perinatal period and over their lifetime.

Keywords Cost-effectiveness . Decision modelling . Dietary intervention . Epidemiology . Gestational diabetes mellitus . Life table modelling . Physical activity . Pregnancy . Type 2 diabetes mellitus

Zanfina Ademi

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1 Centre for Medicine Use and Safety, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Melbourne, Australia

2 School of Public Health and Preventive Medicine, Monash University, Melbourne, Australia

3 Diabetes and Population Health, Baker Heart and Diabetes Institute, Melbourne, Australia

Islet Autoantibody Standardization Program: interlaboratory comparison of insulin autoantibody assay performance in 2018 and 2020 workshops

Ilaria Marzinotto1 iD David L. Pittman2 iD Alistair J. K. Williams3 iD Anna E. Long3 iD Peter Achenbach4 iD Michael Schlosser5,6 & Beena Akolkar7 iD William E. Winter2 & Vito Lampasona1 iD participating laboratories

Received: 30 August 2022 /Accepted: 21 December 2022 / The Author(s) 2023

Abstract

Aims/hypothesis The Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring autoantibodies in type 1 diabetes and the concordance of results across laboratories. IASP organises international workshops distributing anonymised serum samples to participating laboratories and centralises the collection and analysis of results. In this report, we describe the results of assays measuring IAA submitted to the IASP 2018 and 2020 workshops. Methods The IASP distributed uniquely coded sera from individuals with new-onset type 1 diabetes, multiple islet autoantibodypositive individuals, and diabetes-free blood donors in both 2018 and 2020. Serial dilutions of the anti-insulin mouse monoclonal antibody HUI-018 were also included. Sensitivity, specificity, area under the receiver operating characteristic curve (ROCAUC), partial ROC-AUC at 95% specificity (pAUC95) and concordance of qualitative/quantitative results were compared across Results Results from 45 IAA assays of seven different formats and from 37 IAA assays of six different formats were submitted to the IASP in 2018 and 2020, respectively. The median ROC-AUC was 0.736 (IQR 0.617–0.803) and 0.790 (IQR 0.730–0.836), while the median pAUC95 was 0.016 (IQR 0.004–0.021) and 0.023 (IQR 0.014–0.026) in the 2018 and 2020 workshops, respectively. Assays largely differed in AUC (IASP 2018 range 0.232–0.874; IASP 2020 range 0.379–0.924) and pAUC95 (IASP 2018 and IASP 2020 range 0–0.032). Conclusions/interpretation Assay formats submitted to this study showed heterogeneous performance. Despite the high variability across laboratories, the in-house radiobinding assay (RBA) remains the gold standard for IAA measurement. However, novel non-radioactive IAA immunoassays showed a good performance and, if further improved, might be considered valid alternatives to RBAs.

Keywords Autoantibodies . IAA . IASP interlaboratory comparison study . Sensitivity . Specificity . Type 1 diabetes

Ilaria Marzinotto and David L. Pittman contributed equally.

Alistair John Kerr Williams died on 17th September 2020.

* Peter Achenbach

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* Vito Lampasona

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1 San Raffaele Diabetes Research Institute, San Raffaele Scientific Institute, Milan, Italy

2 Department of Pathology, University of Florida, Gainesville, FL, USA

3 Diabetes and Metabolism, Translational Health Sciences, University of Bristol, Bristol, UK

4 Institute of Diabetes Research, Helmholtz Munich, German Research Center for Environmental Health, Neuherberg, Germany

5 Department of General Surgery, Visceral, Thoracic and Vascular Surgery, University Medical Center Greifswald, Greifswald, Germany

6 Institute of Pathophysiology, Research Group of Predictive Diagnostics, University Medical Center Greifswald, Karlsburg, Germany

7 Division of Diabetes, Endocrinology, and Metabolic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, USA

https://doi.org/10.1007/s00125-023-05877-9 / Published online: 10 February 2023

Embracing complexity: making sense of diet, nutrition, obesity and type 2 diabetes

Nita G. Forouhi1

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1 MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Institute of Metabolic Science, Cambridge Biomedical Campus, Cambridge, UK

Received: 27 July 2022 /Accepted: 13 December 2022 / Published online: 14 February 2023 © The Author(s) 2023

Abstract

      Nutrition therapy has been emphasised for decades for people with type 2 diabetes, and the vital importance of diet and nutrition is now also recognised for type 2 diabetes prevention. However, the complexity of diet and mixed messages on what is unhealthy, healthy or optimal have led to confusion among people with diabetes and their physicians as well as the general public. What should people eat for the prevention, management and remission of type 2 diabetes? Recently, progress has been made in research evidence that has advanced our understanding in several areas of past uncertainty. This article examines some of these issues, focusing on the role of diet in weight management and in the prevention and management of type 2 diabetes. It considers nutritional strategies including low-energy, low-fat and low-carbohydrate diets, discusses inter-relationships between nutrients, foods and dietary patterns, and examines aspects of quantity and quality together with new developments, challenges and future

Keywords Diet . Epidemiology . Nutrients . Nutrition . Obesity . Quality . Quantity . Review . Study design . Type 2 diabetes

Abbreviations

DASH Dietary Approaches to Stop Hypertension

GI Glycaemic index

GL Glycaemic load

NHS National Health Service

Causal factors underlying diabetes risk informed by Mendelian randomisation analysis: evidence, opportunities and challenges

Shuai Yuan1 & Jordi Merino2,3,4,5 & Susanna C. Larsson1,6

Received: 5 October 2022 /Accepted: 4 January 2023 / Published online: 14 February 2023

© The Author(s) 2023

Abstract

      Diabetes and its complications cause a heavy disease burden globally. Identifying exposures, risk factors and molecular processes causally associated with the development of diabetes can provide important evidence bases for disease prevention and spur novel therapeutic strategies. Mendelian randomisation (MR), an epidemiological approach that uses genetic instruments to infer causal associations between an exposure and an outcome, can be leveraged to complement evidence from observational and clinical studies. This narrative review aims to summarise the evidence on potential causal risk factors for diabetes by integrating published MR studies on type 1 and 2 diabetes, and to reflect on future perspectives of MR studies on diabetes. Despite the genetic influence on type 1 diabetes, few MR studies have been conducted to identify causal exposures or molecular processes leading to increased disease risk. In type 2 diabetes, MR analyses support causal associations of somatic, mental and lifestyle factors with development of the disease. These studies have also identified biomarkers, some of them derived from the gut microbiota, and molecular processes leading to increased disease risk. These studies provide valuable data to better understand disease pathophysiology and explore potential therapeutic targets. Because genetic association studies have mostly been restricted to participants of European descent, multi-ancestry cohorts are needed to examine the role of different types of physical

Susanna C. Larsson

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1 Unit of Cardiovascular and Nutritional Epidemiology, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden

2 Diabetes Unit and Center for Genomic Medicine, Massachusetts General Hospital, Boston, MA, USA

3 Programs in Metabolism and Medical and Population Genetics, Eli and Edythe L. Broad Institute of MIT and Harvard, Cambridge, MA, USA

4 Department of Medicine, Harvard Medical School, Boston, MA, USA

5 Novo Nordisk Foundation Center for Basic Metabolic Research, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

6 Unit of Medical Epidemiology, Department of Surgical Sciences, Uppsala University, Uppsala, Sweden activity, dietary components, metabolites, protein biomarkers and gut microbiome in diabetes development.

Keywords Causality . Diabetes . Mendelian randomisation . Review . Risk factor

Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis

Rongli Zhang, Yahui Zhang, Liyuan Hou and Chengyong Yan*

Abstract

Background Necrotizing fasciitis is a rapid and severe soft tissue infection that targets subcutaneous fat tissue, muscle, and fascia. This study compares the clinical outcomes of vacuum-assisted closure (VAC) versus conventional dressing on necrotizing fasciitis.

Methods We systematically searched Embase, Cochrane, and PubMed for clinical trials (published between January 1, 1995 and September 30, 2021), which compared VAC with conventional dressing for necrotizing fasciitis. The mortality rate of necrotizing fasciitis was the primary outcome of this study. The number of debridements, the total length of hospital stay, and the complication rate were secondary outcomes. A random effects model assessed all pooled

Results A total of 230 identified studies and seven controlled clinical trials met the inclusion criteria and were included in this analysis (n =249 participants). Compared to the conventional dressing, patients treated with VAC had a significantly lower mortality rate [OR =0.27, 95% CI (0.09, 0.87)] (P=0.03). Total length of hospital stays [MD=8.46, 95% CI (− 0.53, 17.45)] (P=0.07), number of debridements [MD =0.86, 95% CI (− 0.58, 2.30)] (P=0.24), and complication rate [OR=0.64, 95% CI (0.07, 5.94)] (P=0.69) were not significant. These results did not show significant diferences between both groups treated with VAC or conventional treatment.

Conclusion VAC could significantly decrease the death rate compared to conventional dressing. No significant impacts were found on the number of debridements, the total length of hospital stay, and the complication rate in this study. Level of evidence Level-III. Registration Research Registry (reviewregistry1246).

Keywords Necrotizing fasciitis, Vacuum-assisted closure, Conventional dressing, Meta-analysis

*Correspondence:

Chengyong Yan

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Department of Orthopaedic Surgery, Third Hospital of Hebei Medical

University, Shijiazhuang, China

© The Author(s) 2023. Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativeco mmons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

Serum neurofilament light chain: a novel biomarker for early diabetic sensorimotor polyneuropathy

Haifa Maalmi1,2  iD  Alexander Strom1,2  iD Agnese Petrera2,3  iD Stefanie M. Hauck2,3  iD Klaus Strassburger2,4  iD Oliver Kuss2,4,5  iD Oana-Patricia Zaharia1,2,6  iD Gidon J. Bönhof1,2,6  iD Wolfgang Rathmann2,4  iD Sandra Trenkamp1,2  iD Volker Burkart1,2  iD Julia Szendroedi1,2,7,8  iD Dan Ziegler1,2,6  iD Michael Roden1,2,6  iD Christian Herder 1,2,6  iD the GDS Group

Received: 31 May 2022 / Accepted: 19 October 2022 /Published online: 6 December 2022  ©The Author(s) 2022

Abstract

Aims/hypothesis No established blood-based biomarker exists to monitor diabetic sensorimotor polyneuropathy (DSPN) and evaluate treatment response. The neurofilament light chain (NFL), a blood biomarker of neuroaxonal damage in several neurodegenerative diseases, represents a potential biomarker for DSPN. We hypothesised that higher serum NFL levels are associated with prevalent DSPN and nerve dysfunction in individuals recently diagnosed with diabetes.

Methods This cross-sectional study included 423 adults with type 1 and type 2 diabetes and known diabetes duration of less than 1 year from the prospective observational German Diabetes Study cohort. NFL was measured in serum samples of fasting participants in a multiplex approach using proximity extension assay technology. DSPN was assessed by neurological examination, nerve conduction studies and quantitative sensory testing. Associations of serum NFL with DSPN (defined according to the Toronto Consensus criteria) were estimated using Poisson regression, while multivariable linear and quantile regression models were used to assess associations with nerve function measures. In exploratory analyses, other biomarkers in the multiplex panel were also analysed similarly to NFL.

Results DSPN was found in 16% of the study sample. Serum NFL levels increased with age. After adjustment for age, sex, waist circumference, height, HbA1c, known diabetes duration, diabetes type, cholesterol, eGFR, hypertension, CVD, use of lipidlowering drugs and use of non-steroidal anti-inflammatory drugs, higher serum NFL levels were associated with DSPN (RR [95% CI] per 1-normalised protein expression increase, 1.92 [1.50, 2.45], p<0.0001), slower motor (all p<0.0001) and sensory (all p≤0.03) nerve conduction velocities, lower sural sensory nerve action potential (p=0.0004) and higher thermal detection threshold to warm stimuli (p=0.023 and p=0.004 for hand and foot, respectively). There was no evidence for associations between other neurological biomarkers and DSPN or nerve function measures.

Dan Ziegler, Michael Roden and Christian Herder contributed equally to this study.

Christian Herder

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1 Institute for Clinical Diabetology, German Diabetes Center (Deutsches Diabetes-Zentrum/DDZ), Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf, Düsseldorf, Germany

2 German Center for Diabetes Research (DZD), München-Neuherberg, Germany

3 Metabolomics and Proteomics Core, Helmholtz Zentrum München, German Research Center for Environmental Health (GmbH), Neuherberg, Germany

4 Institute for Biometrics and Epidemiology, German Diabetes Center (Deutsches Diabetes-Zentrum/DDZ), Düsseldorf, Germany

5 Centre for Health and Society, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany

6 Department of Endocrinology and Diabetology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Düsseldorf, Germany

7 Department of Endocrinology, Diabetology, Metabolism and Clinical Chemistry, Heidelberg University Hospital, Heidelberg, Germany

8 Institute for Diabetes and Cancer (IDC) & Joint Heidelberg–IDC Translational Diabetes Program, Helmholtz Center Munich, München-Neuherberg, Germany

Conclusions/interpretation Our findings in individuals recently diagnosed with diabetes provide new evidence associating higher serum NFL levels with DSPN and peripheral nerve dysfunction. The present study advocates NFL as a potential

Keywords Axonal damage . Biomarker . Demyelination . Diabetes . Diabetic neuropathy . Diabetic sensorimotor polyneuropathy . Distal sensorimotor polyneuropathy . Electrophysiological tests . Large fibre . Nerve conduction study . Nerve dysfunction . Nerve injury . Neurofilament light chain . Neurofilaments . Neurological biomarkers . Peripheral nervous system . Peripheral neuropathy . Quantitative sensory tests . Small fibre biomarker for DSPN.

Abbreviations

ADAM15 Disintegrin and metalloproteinase domain

containing protein 15

CDH Cadherin

DSPN Diabetic sensorimotor polyneuropathy

GDS German Diabetes Study

MNCV Motor nerve conduction velocity

NCS Nerve conduction study

NCV Nerve conduction velocity

NFL Neurofilament light chain

NPX Normalised protein expression

NSAID Non-steroidal anti-inflammatory drug

QST Quantitative sensory testing

SFRP1 Secreted frizzled-related protein 1

SNAP Sensory nerve action potential

SNCV Sensory nerve conduction velocity

TDT Thermal detection threshold