EMBARK: A Randomized, Controlled Trial Comparing Three Approaches to Reducing Diabetes Distress and Improving HbA1c in Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of three interventions to reduce diabetes distress (DD) and improve HbA1c among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 276) with elevated DD (a score >2 on the total Type 1 Diabetes Distress Scale) and HbA1c (>7.5%) were recruited from multiple settings and randomly assigned to one of three virtual group-based programs: 1) Streamline, an educator-led education and diabetes self-management program; 2) TunedIn, a psychologist-led program focused exclusively on emotional-focused DD reduction; or 3) FixIt, an integration of Streamline and TunedIn. Assessments of the primary outcomes of DD and HbA1c occurred at baseline and at 3, 6, and 12 months. RESULTS: All three programs demonstrated substantive and sustained reductions in DD (Cohen's d = 0.58-1.14) and HbA1c (range, -0.4 to -0.72) at 12-month follow-up. TunedIn and FixIt participants reported significantly greater DD reductions compared with Streamline participants (P = 0.007). Streamline and TunedIn participants achieved significantly greater HbA1c reductions than did FixIt participants (P = 0.006). CONCLUSIONS: DD can be successfully reduced among individuals with T1D with elevated HbA1c using both the educational/behavioral and emotion-focused approaches included in the study. Although both approaches are associated with significant and clinically meaningful reductions in DD and HbA1c, TunedIn, the emotion-focused program, had the most consistent benefits across both DD and HbA1c. The study findings suggest the overall value of group-based, fully virtual, and time-limited emotion-focused strategies, like those used in TunedIn, for adults with T1D.

The Potential Impact of Continuous Glucose Monitoring Use on Diabetes-Related Attitudes and Behaviors in Adults with Type 2 Diabetes: A Qualitative Investigation of the Patient Experience.

Background: Despite the known glycemic benefits of continuous glucose monitoring (CGM) for adults with type 2 diabetes (T2D), the attitudinal and behavioral changes underlying these glycemic improvements remain understudied. This study aimed to qualitatively explore these changes among a sample of adults with T2D. Methods: In-depth, semistructured interviews were conducted with adults with T2D who had been using CGM for 3-6 months as part of a larger community project in Ohio. Thematic analysis was used to identify themes across participants' experiences. Results: A total of 34 participants provided insights into their experiences with CGM. Six primary themes emerged: (1) Making the Invisible Visible, highlighting the newfound awareness of T2D in daily life. (2) Effective Decision-Making, emphasizing the use of real-time glucose data for immediate and long-term choices. (3) Enhanced Self-Efficacy, describing a renewed sense of control and motivation. (4) Diabetes-Related Diet Modifications. (5) Changes in Physical Activity. (6) Changes in Medication Taking. Conclusions: Participants reported a far-reaching impact of CGM on their daily lives, with many stating that CGM fostered a greater understanding of diabetes and prompted positive behavior changes. The observed attitudinal and behavioral shifts likely contributed synergistically to the significant glycemic benefits observed over the study period. This study highlights the technology's potential to bring about meaningful attitudinal and behavioral changes.

Roles and competencies of the clinical psychologist in adult diabetes care-A consensus report.

AIMS: Psychological care is recognised as an integral part of quality diabetes care. We set out to describe the roles and competencies of the clinical psychologist as a member of the multidisciplinary adult diabetes care team, focused on secondary care. METHODS: The authors are clinically experienced psychologists involved in adult diabetes care, from Australia, Europe and North America, and active members of the international psychosocial aspects of diabetes study group. Consensus was reached as a group on the roles and competencies of the clinical psychologist working in adult diabetes secondary care, building both on expert opinion and a selective review and discussion of the literature on psychological care in diabetes, clinical guidelines and competency frameworks. RESULTS: The clinical psychologist fulfils multiple roles: (1) as a clinician (psychological assessment and therapy), (2) as advisor to the healthcare team (training, consulting), (3) as a communicator and promotor of person-centred care initiatives and (4) as a researcher. Four competencies that are key to successfully fulfilling the above-mentioned roles in a diabetes setting are as follows: (a) specialised knowledge, (b) teamwork and advice, (c) assessment, (d) psychotherapy (referred to as STAP framework). CONCLUSIONS: The roles and competencies of clinical psychologists working in diabetes extend beyond the requirements of most university and post-graduate curricula. There is a need for a comprehensive, accredited specialist post-graduate training for clinical psychologists working in diabetes care, building on the proposed STAP framework. This calls for a collaborative effort involving diabetes organisations, clinical psychology societies and diabetes psychology interest groups.

Training peers to deliver mental health support to adults with type 1 diabetes using the REACHOUT mobile app.

AIMS: While peer support research is growing in the Type 1 diabetes (T1D) community, the peer supporter training (PST) process is rarely documented in detail. This study provides a comprehensive description of PST and evaluation for the REACHOUT mental health support intervention, and examines the feasibility and perceived utility of PST. METHODS: Fifty-three adults with T1D were recruited to participate in a 6-hour, zoom-based PST program for mental health support. The program was structured in three parts: (1) internal motivation, resilience and empathy; (2) mindfulness, emotions and diabetes distress; and (3) active listening and deferring clinical questions to professionals. Candidates were evaluated based on eight pre-established competency criteria during a 5-day support trial with an assigned standardized T1D participant. Perceived usefulness of training skills was also assessed 3 months into the REACHOUT mental health support intervention. RESULTS: Fifty-one of the fifty-three candidates who completed training achieved the criteria to graduate. Mean scores for the eight competency domains were: listens actively (4.55); asks open-ended questions (4.12); expresses empathy (4.42); avoids passing judgment (4.67); sits with strong emotions (4.44); refrains from giving advice (4.38); makes reflections (4.5); and defers medical questions (4.58). Of the skills learned during the PST, 95% rated interpreting and discussing diabetes distress profile and expressing empathy as moderately to extremely useful. CONCLUSIONS: Findings demonstrate that it is feasible to recruit and graduate the number of trainees needed using a rigorous process. Only by making training protocols available can the PST be replicated and translated to other T1D populations (e.g. adolescents, parents of children with T1D).

The Hypoglycemic Fear Syndrome: Understanding and Addressing This Common Clinical Problem in Adults With Diabetes.

Although a broad literature on fear of hypoglycemia and its impact on people with type 1 or type 2 diabetes has accumulated over the past three decades, there has been surprisingly little guidance concerning how best to tackle this problem in clinical care. The aim of this article is to begin filling this gap by describing the "hypoglycemic fear syndrome," which we define as hypoglycemic fear that has become so overwhelming that it leads to avoidance behaviors and chronically elevated glucose levels. We begin by presenting several illustrative cases, describing the syndrome and how it is most commonly presented in clinical care, and detailing its most common precipitants. We then offer practical, evidence-based strategies for clinical intervention, based on the literature and our clinical experience.

Psychosocial and Glycemic Benefits for Insulin-Using Adults With Type 2 Diabetes After Six Months of Pump Therapy: A Quasi-Experimental Approach.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) use in adults with type 1 diabetes offers psychosocial and clinical benefits, but little is known about its impact on such outcomes in the type 2 diabetes (T2D) population. To address this gap, we conducted a quasi-experimental prospective study to assess psychosocial, glycemic, and behavioral changes over six months in T2D adults on multiple daily injections (MDI) who were interested in starting Omnipod DASH, comparing those who did versus did not start on it. METHODS: In total, 458 adults with T2D completed baseline questionnaires assessing psychosocial dimensions (eg, diabetes distress), clinical metrics (eg, HbA1c [glycosylated hemoglobin]), and behavioral measures (eg, missed mealtime boluses). Six months later, 220 (48.0%) completed the same questionnaire again. To examine differences in outcomes over time between those who began CSII (n = 176) versus those who remained on MDI (n = 44), a latent change score approach was used. RESULTS: The CSII users reported greater gains than MDI users on all major psychosocial metrics, including overall well-being (P < .001) diabetes distress (P < .001), perceived T2D impact on quality of life (P = .003), and hypoglycemic worries and concerns (P < .001). The CSII users similarly reported a larger decline in HbA1c than MDI users (P < .05) and greater declines in two critical self-care behaviors: number of missed mealtime boluses (P < .001) and number of days of perceived overeating (P = .001). CONCLUSIONS: The introduction of CSII (Omnipod DASH) in T2D adults can contribute to significant psychosocial, glycemic, and behavioral benefits, indicating that broader use of CSII in the T2D population may be of value.

What Role Might There Be for Continuous Glucose Monitoring in the Assessment of Diabetes Risk?

The term "prediabetes" has traditionally been used to describe the state of abnormal glucose homeostasis (dysglycemia) that could eventually lead to developing clinical type 2 diabetes. The HbA1c, oral glucose tolerance testing, and fasting glucose measurements represent the standard approaches for assessing risk. However, they do not predict with complete accuracy, nor do they provide individualized risk assessment to determine who will develop diabetes. Use of continuous glucose monitoring (CGM) provides a more complete picture of inter- and intraday glucose excursions that may help clinicians and patients quickly identify dysglycemia and make informed personalized intervention decisions. This article discusses the utility of CGM as a tool for both risk assessment and risk management.

The Influence of Real-Time Continuous Glucose Monitoring on Psychosocial Outcomes in Insulin-Using Type 2 Diabetes.

BACKGROUND: To examine the impact of real-time continuous glucose monitoring (rtCGM) on psychosocial outcomes in adults with insulin-using type 2 diabetes (T2D). METHODS: A total of 174 insulin-using adults with T2D completed questionnaires assessing diabetes distress, hypoglycemic confidence, hypoglycemic fear, device-related emotional burden, and device-related trust before and after a six-month trial of rtCGM. Hemoglobin A1c (HbA1c) was assessed at the same time points; impaired hypoglycemic awareness (IAH) was assessed at baseline. Change in psychosocial outcomes was examined with t tests, then modeled as a function of baseline HbA1c and IAH and simultaneous change in HbA1c in multiple regression analyses. RESULTS: Respondents were predominantly male (57.5%) and non-Hispanic white (67.8%). Significant improvement over the trial was observed in hypoglycemic fear (P = .031), hypoglycemic confidence (P < .001), diabetes distress (P < .001), and device-related emotional burden (P < .001). Impaired hypoglycemic awareness at baseline predicted greater improvement in hypoglycemic fear (P = .002), hypoglycemic confidence (P = .003), diabetes distress (P = .013), and device-related emotional burden (P < .001). Higher baseline HbA1c was linked with greater improvement in hypoglycemic fear (P = .030); HbA1c change over the trial was positively associated with change in diabetes distress (P = .010) and device-related emotional burden (P = .003). CONCLUSIONS: Introduction of rtCGM in adults with insulin-using T2D was associated with significant improvements in diabetes-related psychosocial outcomes over six months. Gains were significantly greater among participants reporting IAH and those with higher HbA1c at baseline, thus providing the first evidence regarding which users might more likely benefit.

The AH-HA! Project: Transforming Group Diabetes Self-Management Education Through the Addition of Flash Glucose Monitoring.

Background: The majority of individuals referred to diabetes self-management education and support (DSMES) programs do not access this resource. Of those who do, attrition is high, with anecdotal reports pointing to the didactic and impersonal nature of these programs contributing to low utilization and completion rates. In an effort to develop a more engaging form of DSMES for adults with type 2 diabetes (T2D), we constructed a nondidactic "discovery learning"-based DSMES program centered on real-time flash glucose monitoring (FGM). Methods: In this single-arm pilot study, 35 adults with T2D duration 1-5 years, ages 21-75 years, not using insulin and HbA1c ≥8.0% were introduced to FGM and participated in five weekly group sessions. DSMES content was personalized, emerging from the concerns and questions arising from participants' FGM discoveries. The primary outcome was glycemic change as assessed by blinded FGM at baseline and month 3. Secondary outcomes included psychosocial and behavioral measures. Results: There was a significant gain in percentage time in range (% TIR) 70-180 mg/dL from baseline (55%) to month 3 (74%), and a parallel drop-in percentage time above range (TAR) >180 mg/dL from 44% to 25% (Ps = 0.01). Overall well-being rose significantly (P = 0.04), whereas diabetes distress showed a nonsignificant drop. Participants reported improvements in healthy eating (P < 0.001) and physical activity, although the latter did not reach statistical significance. Conclusions: These findings support a new approach to DSMES, a method that integrates FGM with a highly interactive and engaging patient-driven "discovery learning" approach to education.

Young Adult Depression, Antidepressant Prescriptions, and Therapy Intensification in People With Incident Depression in the United States.

Objective: To evaluate the temporal trend in young adult depression, prescription patterns of first- and second-line antidepressants, and factors influencing therapy intensification for depression stratified by sex.Methods: A retrospective cohort of people aged ≥ 18 years with incident depression between 2006 and 2017 was extracted from the Centricity Electronic Medical Records.Results: Among 2,201,086 people with depression (82% on antidepressants), the mean age was 47 years, 29% were male, 40% had cardiometabolic multimorbidity, and 32% were diagnosed at age < 40 years (young adult depression). Prevalence of young adult depression increased significantly from 26% to 36% with a higher proportion in females compared to males (34% vs 26%) between 2006 and 2017. Selective serotonin reuptake inhibitors (SSRIs) were the most prescribed first-line antidepressant (56%), with a prescribing rate increase from 47 per 1,000 person-years to 81 per 1,000 person-years. Among first-line antidepressant recipients, 23% had treatment intensification after a median of 17 months. Compared to those aged 60-70 years, younger males and females had a similar significantly higher treatment intensification risk (range of hazard ratio [HR], 1.09-1.46). Cardiometabolic multimorbidity was associated with a 2% (HR CI, 1.01-1.05) and 7% (HR CI, 1.05-1.09) higher treatment intensification risk in males and females, respectively, while anxiety increased the treatment intensification risk by 63% (HR CI, 1.57-1.68) in males and 57% (HR CI, 1.52-1.62) in females. Non-Whites and SSRI initiators had lower risks of treatment intensification (all HR CI < 1).Conclusions: More than one-third of US adults with depression are aged < 40 years with an increasing trend among females. The temporal antidepressant prescribing rates were similar between sex, while significant ethnic disparity in therapy intensification was observed between sex.

Temporal trends in the prevalence and incidence of depression and the interplay of comorbidities in patients with young- and usual-onset type 2 diabetes from the USA and the UK.

AIMS/HYPOTHESIS: We aimed to investigate the prevalence and incidence of depression, and the interplay of cardiometabolic comorbidities, in the differentiation of depression risk between young-onset diabetes (diagnosis at age <40 years) and usual-onset diabetes (diagnosis at age ≥40 years). METHODS: Using electronic medical records from the UK and USA, retrospective cohorts of adults with incident type 2 diabetes diagnosed between 2006 and 2017 were examined. Trends in the prevalence and incidence of depression, and risk of developing depression, in participants with young-onset type 2 diabetes compared with usual-onset type 2 diabetes were assessed separately by sex and comorbidity status. RESULTS: In total 230,932/1,143,122 people with type 2 diabetes from the UK/USA (mean age 58/60 years, proportion of men 57%/46%) were examined. The prevalence of depression in the UK/USA increased from 29% (95% CI 28, 30)/22% (95% CI 21, 23) in 2006 to 43% (95% CI 42, 44)/29% (95% CI 28, 29) in 2017, with the prevalence being similar across all age groups. A similar increasing trend was observed for incidence rates. In the UK, compared with people aged ≥50 years with or without comorbidity, 18-39-year-old men and women had 23-57% and 20-55% significantly higher risks of depression, respectively. In the USA, compared with those aged ≥60 years with or without comorbidity, 18-39-year-old men and women had 5-17% and 8-37% significantly higher risks of depression, respectively. CONCLUSIONS/INTERPRETATION: Depression risk has been increasing in people with incident type 2 diabetes in the UK and USA, particularly among those with young-onset type 2 diabetes, irrespective of other comorbidities. This suggests that proactive mental health assessment from the time of type 2 diabetes diagnosis in primary care is essential for effective clinical management of people with type 2 diabetes.

Improved patient-reported outcomes with iGlarLixi versus premix BIAsp 30 in people with type 2 diabetes in the SoliMix trial.

AIM: To assess patient-reported outcomes (PROs) in the SoliMix trial, which compared the efficacy and safety of iGlarLixi versus BIAsp 30 in people with type 2 diabetes (T2D). MATERIALS AND METHODS: SoliMix (EudraCT: 2017-003370-13), a 26-week, open-label study, randomized (1:1) 887 adults with T2D and HbA1c ≥7.5%-≤10.0% (≥58-≤86 mmol/mol) on basal insulin plus oral antihyperglycaemic drugs (OADs) to once-daily iGlarLixi or twice-daily premix insulin, BIAsp 30. PROs were assessed using the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) questionnaires. RESULTS: Over 26 weeks, iGlarLixi showed greater improvement from baseline versus BIAsp 30 in total TRIM-D score (least squares mean difference [95% confidence interval]: 5.08 [3.69, 6.47]; effect size: 0.32) and in each TRIM-D domain, with the greatest differences seen in diabetes management (8.47 [6.11, 10.84]) and treatment burden (6.95 [4.83, 9.07]). GTEE scores showed a greater proportion of participants and physicians rated a complete or marked improvement of diabetes control with iGlarLixi (80.5%, 82.8%) versus BIAsp 30 (63.3%, 65.1%) at week 26. Post hoc analyses showed that after adjusting for HbA1c, body weight and hypoglycaemia outcomes, iGlarLixi continued to show greater improvements in TRIM-D total scores versus BIAsp 30. CONCLUSIONS: In addition to better glycaemic control, weight benefit and less hypoglycaemia, once-daily iGlarLixi provided improved diabetes management, treatment burden and perceived effectiveness versus twice-daily premix BIAsp 30, further supporting iGlarLixi as an advanced treatment option in people with suboptimally controlled T2D on basal insulin plus OADs.

How introduction of automated insulin delivery systems may influence psychosocial outcomes in adults with type 1 diabetes: Findings from the first investigation with the Omnipod® 5 System.

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.

The Role of Retrospective Data Review in the Personal Use of Real-Time Continuous Glucose Monitoring: Perceived Impact on Quality of Life and Health Outcomes.

Background: To explore whether regularly reviewing one's own retrospective continuous glucose monitoring (CGM) data might be linked with perceived quality of life (QoL) and glycemic benefits. Methods: Adults with type 1 diabetes (N = 300) or insulin-using type 2 diabetes (N = 198) using the Dexcom G5 Mobile or G6 Real-Time CGM (RT-CGM) system and receiving the weekly CLARITY summary report of their glucose data completed a survey exploring their use of the report and its perceived value and impact on QoL and glycemic outcomes. Regression analyses examined whether personal use of the report was associated with QoL, perceived glycemic outcomes, and RT-CGM metrics. Results: The majority reported that receiving and viewing the report contributed to improved hypoglycemic confidence (75.9%) and overall well-being (50.0%), reduced diabetes distress (59.3%-74.1%), and helped to improve A1C (73.1%) and reduce problems with hypoglycemia (61.8%) and chronic hyperglycemia (73.1%). Regularly reviewing the report with family or friends (positive predictor) and doing nothing with the report's information (negative predictor) were independently associated with QoL and perceived glycemic outcomes. Surprisingly, both predictors were also associated with poorer glycemic control (e.g., greater % time above range >180). Conclusions: These findings suggest that receiving a weekly RT-CGM summary report may contribute to QoL and health benefits, especially if the individual chooses to actively review and make use of the report's findings and openly reviews the findings with family or friends. Prospective studies are needed to more precisely determine how retrospective RT-CGM data summaries can best be presented and utilized effectively by adults with diabetes to enhance health outcomes.

Impact of Real-Time CGM Data Sharing on Quality of Life in the Caregivers of Adults and Children With Type 1 Diabetes.

BACKGROUND: To examine caregivers' experiences with real-time continuous glucose monitoring (RT-CGM) data sharing and its impact on quality of life (QoL) and health outcomes. METHODS: Parents of children with type 1 diabetes (T1D) (N = 303) and spouses/partners of T1D adults (N = 212) using the Dexcom G5 Mobile or G6 RT-CGM system and who were actively following their T1Ds' RT-CGM data completed a survey examining their perceived value of data sharing, the impact of sharing on their own QoL and their child/partner's health, and how they used RT-CGM data to support their T1Ds' diabetes management. Regression analyses examined whether their actions were linked to reported changes in QoL and health outcomes. RESULTS: Respondents were predominantly non-Hispanic White (91.1% parents; 88.7% partners), female (78.2% parents; 54.7% partners), and college-educated (65.3% parents; 61.8% partners). The majority reported that data sharing had enhanced hypoglycemic confidence (97.7% parents; 98.1% partners), overall well-being (60.4% parents; 63.2% partners), and sleep quality (78.0% parents; 61.3% partners). Of note, three positive caregiver actions were broadly consistent and significant predictors of QoL and health benefits for both parents and partners: celebrating success related to glycemic control, providing encouragement when glycemic control is challenging, and teamwork discussions about how the caregiver should respond to out-of-range values. CONCLUSIONS: RT-CGM data sharing was associated with a range of QoL and health benefits for caregivers. Degree of benefits was influenced by the collaborative actions taken by caregivers to support their child's or partner's diabetes management. To determine the most effective strategies for collaborative data sharing, longitudinal trials are needed.

A systematic review and meta-analysis to compare the prevalence of depression between people with and without Type 1 and Type 2 diabetes.

AIMS: Diabetes can significantly impact quality of life and mental health. However, inconsistencies have been reported in the prevalence of depression in those with Type 1 and Type 2 diabetes, and those without. Systematic reviews also included studies without adequate control subjects. We update existing literature, by comparing depression prevalence between individuals with and without Type 1 and Type 2 diabetes. METHODS: A systematic review and meta-analysis. We searched MEDLINE, EMBASE and PSYCHINFO, from January 1985 to August 2021. Studies were excluded if they failed to have an adequate control group, specified type of diabetes, or reported depression prevalence by type of diabetes. RESULTS: 44 studies were selected for inclusion. The prevalence of depression was significantly higher in people with Type 1 (22% vs 13%, OR = 2.10 (95% CI: 1.23, 3.52)), or Type 2 diabetes (19% vs 11%, OR = 1.76 (1.55, 2.01)) compared to those without diabetes. There was no association between study effect size and mean age or gender. Findings did not significantly differ between methods of depression assessment. Prevalence of depression in people with diabetes was higher in studies carried out in specialist care (36%, OR = 3.14 (2.12, 4.63)) compared to those in community or primary care (12%, OR = 1.51 (1.35, 1.70) and in low- and middle-income countries (OR = 2.58 (1.91, 3.50) compared to countries with high income economies (OR = 1.59 (1.39, 1.82)). CONCLUSIONS: Depression prevalence remains significant in those with type 1 and type 2 diabetes. Effective chronic disease management in people with diabetes is important, particularly screening and managing depression and diabetes distress in specialist care settings.

Higher Rates of Persistence and Adherence in Patients with Type 2 Diabetes Initiating Once-Weekly vs Daily Injectable Glucagon-Like Peptide-1 Receptor Agonists in US Clinical Practice (STAY Study).

INTRODUCTION: Reducing dosing frequency may lower treatment burden and improve persistence and adherence. This retrospective, observational study assessed persistence and adherence in patients with type 2 diabetes (T2D) initiating once-weekly or daily injectable glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in US clinical practice. METHODS: The study used data from adults (≥ 18 years) with T2D who were included in the IBM MarketScan Explorys Claims-EMR Data Set for ≥ 180 days pre-index and ≥ 365 days post-index, were GLP-1 RA and insulin naïve at first claim (index date) for once-weekly or daily injectable GLP-1 RAs (follow-up: index date + 365 days), and were propensity score (PS) matched 1:1 by baseline characteristics. Persistence, defined as the stay time, was assessed using Kaplan-Meier analysis and Cox proportional hazards models. Adherence was defined as a proportion of days covered of 0.8 or greater. To assess whether patients with more advanced disease would benefit from long-acting treatments, patients were matched to the baseline characteristics of basal insulin initiators using inverse probability of treatment weighting (IPTW). RESULTS: The PS-matched cohorts (n = 784 each) had similar baseline characteristics. Once-weekly regimens were associated with significantly higher persistence than daily treatments (median stay time: 333 vs 269 days; hazard ratio 0.80 [95% confidence interval 0.71, 0.90]; p < 0.01) and with significantly higher adherence than daily regimens at 6 months and 12 months (p < 0.01 for both). Mean glycated haemoglobin reductions were greater with once-weekly than with daily treatment at 6 months (- 1.1% vs - 0.9%; p < 0.01) and 12 months (- 0.9% vs - 0.7%; p = not significant); adherent patients experienced greater reductions than those with poor adherence. Results were similar in the IPTW-matched analysis. CONCLUSION: In US clinical practice, once-weekly injectable treatments are associated with better persistence and adherence than daily regimens over 1 year. Once-weekly regimens may also benefit patients with more advanced T2D.

For people who take medication over a prolonged time, less frequent doses are often more convenient. This can help people to continue with treatment for as long as prescribed (persistence) and to take their medication as prescribed (adherence). This study examined persistence and adherence in people with type 2 diabetes who started treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The GLP-1 RAs in this study are injected under the skin using a small needle. Some types are given daily and others are given once weekly. We used a US database of medical records to identify people with type 2 diabetes who had been prescribed these medications and split them into two groups (784 people each) with similar characteristics. One group had received once-weekly GLP-1 RAs and the other group had received daily GLP-1 RAs. We found that the once-weekly group continued taking their medication for longer (333 days) than the daily group (269 days). People in the once-weekly group were also 20% less likely to stop the treatment too early than those in the daily group. More people in the once-weekly group took their medication as prescribed over 1 year compared with the daily group. The once-weekly group also had larger reductions in blood sugar levels after 1 year than the daily group. People who took their medication as prescribed had the greatest improvements in blood sugar levels. Our results suggest that GLP-1 RAs that are injected less frequently can help people to take their medication as prescribed.

Toward a more comprehensive understanding of the emotional side of type 2 diabetes: A re-envisioning of the assessment of diabetes distress.

AIMS: To develop an updated, more theoretically sound system for describing and assessing diabetes-related emotional distress (DD) in adults with type 2 diabetes (T2D). METHODS: Items were developed from qualitative interviews with 11 adults with T2D and 6 clinicians, then categorized as reflecting a core emotional experience of DD or a primary source of DD. Items were then administered to a national sample of TCOYD Registry participants. Data were analyzed using both exploratory (EFA) and confirmatory (CFA) factor analyses. Reliability (alpha) and construct validity also were assessed. RESULTS: EFAs with 599 adults (258 insulin users, 341 non-insulin users) yielded a coherent DD Core scale and 7 DD Source scales (management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma, healthcare access), which were confirmed by CFA. All alphas were >0.65. DD Core and DD Source scales were associated with criterion variables (all p < .001). Higher DD Core scores were linked to higher HbA1c, BMI, more frequent severe hypoglycemia, and poorer self-management (all p < .001). CONCLUSIONS: Good reliability and validity were found for this two-part T2DD Assessment System. It reflects a more contemporary and actionable approach to DD assessment that distinguishes between its key emotional dimension and its underlying contributors.

Personal Continuous Glucose Monitoring Use Among Adults with Type 2 Diabetes: Clinical Efficacy and Economic Impacts.

PURPOSE OF REVIEW: This article reviews recent clinical efficacy research and economic analysis of the use of personal continuous glucose monitoring (CGM) in type 2 diabetes (T2D). RECENT FINDINGS: Studies from the past 5 years include a variety of randomized controlled trials, meta-analyses, and other studies which generally favor CGM over self-monitoring of blood glucose (SMBG) in T2D, especially among people with T2D treated with insulin. Concurrently, some studies show no significant difference, but there is no evidence of worse outcomes with CGM. CGM is frequently associated with greater reduction in HbA1c than is SMBG. HbA1c reductions tend to be greater when baseline HbA1c is higher. Reductions in hypoglycemia and hyperglycemia have also been demonstrated with CGM in people with T2D, as have comfort with, preference for, and psychosocial benefits of CGM compared to SMBG. There is a small but growing evidence base on the economics and cost-effectiveness of CGM in T2D. CGM has been clearly demonstrated to have clinical benefits in people with T2D, especially among those treated with insulin. Economic and cost-effectiveness data are more scant but are generally favorable. CGM should be an important consideration in the management of T2D, and its use is likely to increase as efficacy data accumulate further and as costs associated with CGM gradually decrease.