Delphi-Based Consensus on Treatment Intensification in Type 2 Diabetes Subjects Failing Basal Insulin Supported Oral Treatment: Focus on Basal Insulin + GLP-1 Receptor Agonist Combination Therapies

Fadini, Gian Paolo; Disoteo, Olga; Candido, Riccardo; Bartolo, Paolo Di; Laviola, Luigi; Consoli, Agostino

doi:10.1007/s13300-021-01012-2

Cited by 7 publications

(4 citation statements)

References 54 publications

(60 reference statements)

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“…Recently, combinations of glucagon-like peptide 1 receptor agonists (GLP-1RAs) and basal insulin have been recommended by international guidelines as an alternative option. Such combinations have shown the same efficacy as the basal bolus treatment regimen in achieving glycemic control, but with a lower risk of hypoglycemia and weight gain and using a lower insulin dose [ 3 – 5 ].…”

Section: Introductionmentioning

confidence: 99%

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Fadini

Buzzetti

Fittipaldi³

et al. 2022

Diabetes Ther

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Introduction IDegLira was shown to maintain glycemic control while reducing risk of hypoglycemia and body weight gain. The REX study was designed to generate real-world evidence on the use of IDegLira in Italian clinical practice in two different subgroups of patients, those switching to IDegLira from a basal insulin-supported oral therapy (BOT group) and those from a basal plus bolus insulin regimen (BB group). Methods Adult patients with T2D diagnosed for at least 12 months and having started IDegLira 2–3 months prior to enrolment, coming from a BOT or BB regimen, were enrolled in this multicenter observational prospective cohort study conducted in 28 Italian centers. This paper presents the methodological framework of the REX study and provides the interim analysis results describing the patients’ baseline characteristics and the clinical reasons for IDegLira treatment initiation. Results Of the 360 patients enrolled in the REX study, 331 were considered eligible for this interim analysis, 76.4% in the BOT and 23.6% in the BB group. Mean (SD) HbA1c was 8.5% (1.4) in the BOT and 8.2% (1.7) in the BB group. The most common T2D complications were diabetic macroangiopathy and diabetic nephropathy in both groups. The median (interquartile range) insulin daily dose before IDegLira was 15.0 (10.0–20.0) units in the BOT group and 42 (30.0–52.0) in the BB group. Oral antidiabetics were taken by 98% and 51.3% of patients, respectively. The main reason for switching to IDegLira was the inadequate glycemic control in the BOT group (86% of patients), and the intent to simplify the treatment in the BB group (66.7%). Conclusions IdegLira is initiated after BOT in inadequately controlled patients to improve glycemic control, whereas in BB patients it is used to simplify the therapeutic regimen. Final results of the REX study will shed light on patients’ outcomes after IdegLira treatment under routine clinical care. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01287-z.

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Section: Introductionmentioning

confidence: 99%

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Fadini

Buzzetti

Fittipaldi³

et al. 2022

Diabetes Ther

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“…The Delphi method has been widely used in health sciences [ 83 ] to generate clinical recommendations [ 84 ] and standards and guidelines for theoretical or methodological issues [ 83 , 85 , 86 ] for a range of chronic illnesses such as diabetes [ 87 , 88 ], cancer [ 89 , 90 ], asthma [ 91 ], rheumatoid arthritis [ 92 ], and spinal cord injury [ 93 , 94 ]. Our objective using a Delphi procedure is to develop a CIS that facilitates optimal communication of information to people with DCM about the condition at the point of diagnosis.…”

Section: Methodsmentioning

confidence: 99%

Toward Shared Decision-Making in Degenerative Cervical Myelopathy: Protocol for a Mixed Methods Study

Sangeorzan¹,

Antonacci²,

Martin³

et al. 2023

JMIR Res Protoc

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Background Health care decisions are a critical determinant in the evolution of chronic illness. In shared decision-making (SDM), patients and clinicians work collaboratively to reach evidence-based health decisions that align with individual circumstances, values, and preferences. This personalized approach to clinical care likely has substantial benefits in the oversight of degenerative cervical myelopathy (DCM), a type of nontraumatic spinal cord injury. Its chronicity, heterogeneous clinical presentation, complex management, and variable disease course engenders an imperative for a patient-centric approach that accounts for each patient’s unique needs and priorities. Inadequate patient knowledge about the condition and an incomplete understanding of the critical decision points that arise during the course of care currently hinder the fruitful participation of health care providers and patients in SDM. This study protocol presents the rationale for deploying SDM for DCM and delineates the groundwork required to achieve this. Objective The study’s primary outcome is the development of a comprehensive checklist to be implemented upon diagnosis that provides patients with essential information necessary to support their informed decision-making. This is known as a core information set (CIS). The secondary outcome is the creation of a detailed process map that provides a diagrammatic representation of the global care workflows and cognitive processes involved in DCM care. Characterizing the critical decision points along a patient’s journey will allow for an effective exploration of SDM tools for routine clinical practice to enhance patient-centered care and improve clinical outcomes. Methods Both CISs and process maps are coproduced iteratively through a collaborative process involving the input and consensus of key stakeholders. This will be facilitated by Myelopathy.org, a global DCM charity, through its Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy community. To develop the CIS, a 3-round, web-based Delphi process will be used, starting with a baseline list of information items derived from a recent scoping review of educational materials in DCM, patient interviews, and a qualitative survey of professionals. A priori criteria for achieving consensus are specified. The process map will be developed iteratively using semistructured interviews with patients and professionals and validated by key stakeholders. Results Recruitment for the Delphi consensus study began in April 2023. The pilot-testing of process map interview participants started simultaneously, with the formulation of an initial baseline map underway. Conclusions This protocol marks the first attempt to provide a starting point for investigating SDM in DCM. The primary work centers on developing an educational tool for use in diagnosis to enable enhanced onward decision-making. The wider objective is to aid stakeholders in developing SDM tools by identifying critical decision junctures in DCM care. Through these approaches, we aim to provide an exhaustive launchpad for formulating SDM tools in the wider DCM community. International Registered Report Identifier (IRRID) DERR1-10.2196/46809

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“…The initiative was born as a follow-up to a Consensus Delphi Project, the results of which have recently been published [3]. Six virtual meetings were organized, each of them moderated by two tutors.…”

Section: Methodsmentioning

confidence: 99%

“…This study is the second phase of a project related to patients with T2DM failing basal insulin supported oral therapy (BOT) aimed to identify a set of actions to promote the reduction of inappropriate clinical practices [3].…”

Section: Introductionmentioning

confidence: 99%

Identification of the Inappropriate Clinical Actions (DON'T) to Improve the Management of Patients with Type 2 Diabetes Failing Basal Insulin Supported Oral Treatment: Results of Survey for a Panel of Diabetes Specialists in Italy

Leto

Barchetta

Candia³

et al. 2021

Diabetes Ther

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Delphi-Based Consensus on Treatment Intensification in Type 2 Diabetes Subjects Failing Basal Insulin Supported Oral Treatment: Focus on Basal Insulin + GLP-1 Receptor Agonist Combination Therapies

Cited by 7 publications

References 54 publications

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

IDegLira for the Real-World Treatment of Type 2 Diabetes in Italy: Protocol and Interim Results from the REX Observational Study

Toward Shared Decision-Making in Degenerative Cervical Myelopathy: Protocol for a Mixed Methods Study

Identification of the Inappropriate Clinical Actions (DON'T) to Improve the Management of Patients with Type 2 Diabetes Failing Basal Insulin Supported Oral Treatment: Results of Survey for a Panel of Diabetes Specialists in Italy

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