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Aims: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System., Methods: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses., Results: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen)., Conclusions: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D., Clinical Trials Registration Number: NCT04196140., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Aims: To investigate experiences of people with type 2 diabetes (T2DM) at the clinic visit when an additional oral antidiabetes drug (OAD) is prescribed, and how this affects their quality of life, self-management and key outcomes., Methods: We surveyed adults with T2DM from a large multinational study of patient-physician communication during early T2DM treatment (IntroDia®). We examined their experiences when an additional OAD is prescribed ("add-on") after initial OAD monotherapy, focusing on 24 key conversational elements, overall patient-perceived communication quality (PPCQ), and associations with current patient-reported outcomes. The links between PPCQ and people's efforts to delay add-on therapy were also assessed., Results: 4235 people with T2DM prescribed an additional OAD, or a combination of two, were analysed. Exploratory factor analyses of the conversational elements during add-on yielded three coherent, meaningful factors: Encouraging (Cronbach's α = 0.62), Collaborative (α = 0.81), and Discouraging (α = 0.81). PPCQ was positively associated with Encouraging (β = +1.252, p < 0.001) and Collaborative (β = +1.206, p < 0.001), but negatively associated with Discouraging (β = -0.895, p < 0.001). Better PPCQ at add-on was associated with less diabetes distress, greater well-being and better self-care at the present time. Approximately 20% of people bargained (two-thirds successfully) with their physician to delay additional medication. Non-bargaining individuals reported significantly better mean PPCQ, diabetes distress, well-being and self-care than those who bargained., Conclusions: Encouraging and patient-inclusive conversations at add-on moments may improve patient well-being and self-care outcomes. People with T2DM who attempted to delay additional medication reported poorer PPCQ and outcomes., (Copyright © 2019. Published by Elsevier B.V.)

Aims: Physician-patient communication when discussing the need for additional oral medication for type 2 diabetes (add-on) may affect the self-care of people with this condition. We aimed to investigate physicians' recalled experiences of the add-on consultation., Methods: We conducted a cross-sectional survey of physicians treating people with type 2 diabetes in 26 countries, as part of a large cross-national study of physician-patient communication during early treatment of type 2 diabetes (IntroDia®). The survey battery included novel questions about physician experiences at add-on and the Jefferson Scale of Physician Empathy., Results: Of 9247 eligible physicians, 6753 responded (73.0% response rate). Most (82%) agreed that physician-patient discussions at add-on strongly influence patients' disease acceptance and treatment adherence. Half the physicians reported ≥1 challenge in most or all add-on conversations, with a significant inverse relationship between frequency of challenges and Jefferson Scale of Physician Empathy score (standardised β coefficient: -0.313; p < 0.001). Physicians estimated that only around half their patients with type 2 diabetes follow their self-care advice. Exploratory factor analysis of physician beliefs about why their patients did not follow recommendations yielded two distinct dimensions: psychosocial barriers (e.g. depressed mood) and personal failings of the patient (e.g. not enough willpower) (r = 0.37, p < 0.001)., Conclusions: Physicians' empathy and beliefs about their patients may play a significant role in their success with the add-on conversation and, consequently, promotion of patient engagement and self-care. Although the study was limited by its retrospective, cross-sectional nature, the findings from IntroDia® may inform efforts to improve diabetes care., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Aims: To investigate patient experiences during the diagnosis of type 2 diabetes mellitus (T2DM), focusing on how physician-patient communication at diagnosis influences patients' psychosocial stress and subsequent self-management and outcomes., Methods: We surveyed adults with T2DM in 26 countries in a large cross-national study of physician-patient communication during early T2DM treatment (IntroDia®). The self-report questionnaire assessed retrospectively patient experiences during diagnosis conversations (focusing on 43 possible conversational elements, and communication quality) and potential effects on patient-reported outcomes., Results: Data from 3628 people with T2DM who had been prescribed oral treatment at diagnosis were analysed. Exploratory factor analyses of the conversational elements yielded four coherent, meaningful factors: Encouraging (Cronbach's α=0.86); Collaborative (α=0.88); Recommending Other Resources (α=0.75); and Discouraging (α=0.72). Patient-perceived communication quality (PPCQ) at diagnosis was positively associated with Encouraging (β=+1.764, p<0.001) and Collaborative (β=+0.347, p<0.001), negatively associated with Discouraging (β=-1.181, p<0.001) and not associated with Recommending Other Resources (β=+0.087, p=0.096), using a stable path model. PPCQ was associated with less current diabetes distress, greater current well-being and better current self-care. Conversation elements comprising factors associated with better PPCQ (Encouraging and Collaborative) were recalled more frequently by patients than elements associated with poor PPCQ (Discouraging)., Conclusions: Better physician-patient communication at T2DM diagnosis may contribute to subsequent greater patient well-being and self-care, and may be enhanced by greater physician use of Collaborative and Encouraging conversation elements., (Copyright © 2017 Elsevier B.V. All rights reserved.)

A growing number of instruments measuring diabetes-specific health-related quality of life (HRQOL) have been identified in previous systematic reviews, the most recent being published in 2008. The purpose of this paper is report on an updated systematic review of diabetes-specific HRQOL measures highlighting the time period 2006-2016; to deconstruct existing diabetes-specific HRQOL measures into a simple framework for evaluating the goodness-of-fit between specific research needs and instrument characteristics; and to present core characteristics of measures not yet reported in other reviews to further facilitate scale selection. Using the databases Medline, Pubmed, CINAHL, OVID Embase, and PsycINFO, we identified 20 diabetes-specific HRQOL measures that met our inclusion criteria. For each measure, we extracted eight core characteristics for our measurement selection framework. These characteristics include target population (type 1 vs. type 2), number and type of HRQOL dimensions measured and scored, type of score and calculation algorithm, sensitivity to change data reported in subsequent studies, number of survey items, approximate time length to complete, number of studies using the instrument in the past 10years, and specific languages instruments is translated. This report provides a way to compare and contrast existing diabetes-specific HRQOL measures to aid in appropriate scale selection and utilization., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Introduction: Patients with T2DM often view self-monitoring of blood glucose (SMBG) as burdensome and pointless, which may affect their broader attitudes toward diabetes management. We examined how a structured SMBG protocol influenced diabetes self-efficacy and autonomous motivation over time, and linked these to changes in glycemic control., Materials and Methods: The Structured Testing Program (STeP) is a 12-month, two-arm, cluster-randomized trial that assessed the efficacy of structured SMBG in 483 insulin-naïve T2DM patients. Measures included: Confidence in Diabetes Self-Care for Type 2 patients (CIDS-T2), Diabetes-related Autonomous Motivation (DRAM), self-management behaviors and HbA1c., Results: Intent-to-treat (ITT) and per-protocol (PP) analyses showed significant increases in CIDS-T2 scores over time (main effects p<0.0001). PP analysis showed significant between-group differences (p<0.05), with adherent STG patients displaying greater CIDS-T2 improvement than ACG patients. PP analyses showed main and between-group effects in DRAM with similar findings. Changes in CIDS-T2 were related to HbA1c changes over time; no self-management variable mediated this relationship. CIDS-T2 and HbA1c displayed a significant time-concordant relationship., Discussion: Structured SMBG leads to significant increases in self-confidence and autonomous motivation associated with diabetes self-management. Changes in self-confidence are linked to changes in glycemic control and share a time-concordant relationship., (Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.)

Aims: To examine issues of weight misperception, perceived importance of weight management, and patient reports of their HCP's weight-related recommendations among patients with type 2 diabetes., Methods: 575 overweight adults with type 2 diabetes completed a survey that assessed perceptions about weight management and discussions with HCP's about weight issues., Results: Among patients with BMI>30, weight misperception was rare (<10%) and perceived importance of weight loss common (>85%). Among overweight patients with BMI<30, weight misperception was more common (47%) and importance of weight loss was endorsed less frequently (68%). Most patients reported that HCP's had advised weight loss (72%) and discussed weight issues at most visits (59%). However, recommendations from HCP's were rarely specific. Few were informed by HCP's that certain diabetes medications might make weight management difficult. Weight misperception was less common, importance of weight loss was more common and weight management efforts were more frequent when HCPs discussed these issues directly., Conclusions: Most overweight patients with type 2 diabetes recognize the importance of weight management. Patient reports indicate that HCP's are actively engaged in promoting weight loss and that their recommendations, when specific, are associated with patients' more frequent weight management efforts., (Copyright 2010 Elsevier Ireland Ltd. All rights reserved.)