Psychosocial outcomes with the Omnipod® 5 Automated Insulin Delivery System in caregivers of very young children with type 1 diabetes.

AIM: Automated insulin delivery (AID) systems have demonstrated improved glycaemic outcomes in people with type 1 diabetes (T1D), yet limited data exist on these systems in very young children and their impact on caregivers. We evaluated psychosocial outcomes following use of the tubeless Omnipod® 5 AID System in caregivers of very young children. MATERIALS AND METHODS: This 3-month single-arm, multicentre, pivotal clinical trial enrolled 80 children aged 2.0-5.9 years with T1D to use the Omnipod 5 AID System. Caregivers completed questionnaires assessing psychosocial outcomes-diabetes distress (Problem Areas in Diabetes), hypoglycaemia confidence (Hypoglycemia Confidence Scale), well-being (World Health Organization 5 Well-Being Index), sleep quality (Pittsburgh Sleep Quality Index), insulin delivery satisfaction (Insulin Delivery Satisfaction Survey) and system usability (System Usability Scale) at baseline with standard therapy and after 3 months of AID use. RESULTS: Following 3 months of Omnipod 5 use, caregivers experienced significant improvements across all measures, including diabetes-related psychosocial outcomes (Problem Areas in Diabetes; p < 0.0001, Hypoglycemia Confidence Scale; p < 0.01), well-being (World Health Organization 5 Well-Being Index; p < 0.0001) and perceived system usability (System Usability Scale; p < 0.0001). Significant improvements were seen in the Pittsburgh Sleep Quality Index total score and the overall sleep quality, sleep duration and efficiency subscales (all p < 0.05). Insulin Delivery Satisfaction Survey scores improved on all subscales (greater satisfaction, reduced burden and reduced inconvenience; all p < 0.0001). CONCLUSIONS: Caregivers face unique challenges when managing T1D in very young children. While glycaemic metrics have unquestioned importance, these results evaluating psychosocial outcomes reveal additional meaningful benefits and suggest that the Omnipod 5 AID System alleviates some of the burdens caregivers face with diabetes management.

Inadequate insurance coverage for overweight/obesity management.

OBJECTIVES: To discuss the social, psychological, and access barriers that inhibit weight loss, and to propose steps and initiatives for addressing the growing obesity epidemic. STUDY DESIGN: Narrative review of the obesity epidemic in the US and associated racial/ethnic and socioeconomic disparities. METHODS: An internet search of relevant studies and government reports was conducted. RESULTS: Obesity is a significant health crisis affecting more than 123 million adults and children/adolescents in the US. An estimated 1 in 5 deaths in Black and White individuals aged 40 to 85 years in the US is attributable to obesity. Obesity puts individuals at elevated risk for type 2 diabetes, cardiovascular disease, chronic kidney disease, gastrointestinal disorders, nonalcoholic fatty liver disease, cancer, respiratory ailments, dementia/Alzheimer disease, and other disorders. In the US, significantly more Black (49.9%) and Hispanic (45.6%) individuals are affected by obesity than White (41.4%) and Asian (16.1%) individuals. Health care costs for obesity account for more than $260 billion of annual US health care spending-more than 50% greater in excess annual medical costs per person than individuals with normal weight. CONCLUSIONS: Addressing the obesity epidemic will require a multifaceted approach that focuses on prevention, treatment, and reducing the impact of stigma. Continued advocacy and education efforts are necessary to make progress and improve the health and well-being of individuals affected by obesity.

Promoting Self-Management in Adults with Type 2 Diabetes: Development of the Impact of Glucose Monitoring on Self-Management Scale.

OBJECTIVES: Type 2 diabetes (T2D) management requires behavioural engagement to achieve optimal outcomes and continuous glucose monitoring (CGM) technologies may facilitate self-management. In this study we describe the development and validation of a self-report instrument, the Impact of Glucose Monitoring on Self-Management Scale (IGMSS), assessing the impact of device use (primarily CGM but also self-monitored blood glucose [SMBG]) on the capability, motivation, and opportunity to engage in self-management. METHODS: Potential items were generated from 3 sources: themes and quotes from 13 adults with T2D motivated by CGM use who participated in a qualitative study; behaviour change theory identifying capability, opportunity, and motivation to self-manage; and expert committee review of items. An initial pool of 42 items were generated describing CGM as promoting personalized knowledge, improved health (Capability), improved relationships, having positive device characteristics (Opportunity), and improved engagement in self-management (Motivation). Based on expert committee consensus, items were written so as to be completed by those using any glucose-sensing device (SMBG and CGM). Psychometric evaluation was conducted with 514 English-speaking Canadians. Scale reduction (22 final items) was completed using item-response distribution, internal consistency, factor analysis, and expert opinion. Construct and convergent validity were evaluated using the Impact of Glucose Monitoring Satisfaction Scale, the Diabetes Self-Management Questionnaire, the Diabetes Distress Scale, the 5-item World Health Organization Well-Being Index, and the Centre for Epidemiology Depression Scale. Test-retest reliability was determined for 130 participants. RESULTS: Internal consistency was high for all scales, ranging from 0.73 to 0.91. Test-retest reliability ranged from 0.58 to 0.79, except for Device Characteristics. Construct and convergent validity indices were acceptable. There was substantial overlap between the IGMSS and established measures of CGM satisfaction. IGMSS findings were also predictive of self-management behaviour and emotional functioning. CONCLUSIONS: The IGMSS has positive psychometric characteristics and has the potential to screen people with T2D for engagement in diabetes self-management using CGM or any sensing device. Scores can be determined for various aspects of Capability (Personalized Knowledge, Improved Health), Opportunity (Relationships and Device Characteristics), and Motivation.

Recommendations for Screening and Monitoring the Stages of Type 1 Diabetes in the Immune Therapy Era.

Type 1 diabetes (T1D) is a complex, chronic autoimmune disease that affects over 1.6 million people in the United States. It is now understood that T1D may be undetected for many years while the disease progresses quietly without producing symptoms. T1D can be identified through diabetes-related autoantibody screening and staged accordingly, enabling healthcare providers to identify high-risk individuals in the early stages of the disease and either provide a stage-specific intervention or offer clinical trial opportunities to preserve beta cell function and anticipate the onset of clinical T1D. Evidence-based clinical practice guidelines currently do not exist for routine diabetes-related autoantibody screening of individuals at risk of developing T1D or of the general population. The purpose of this article is to help clinicians acquire an understanding of the rationale and protocols recommended for identifying patients at risk of developing T1D and monitoring such patients for autoimmune markers and progression of disease from Stage 1 to Stage 3 (clinical disease).

Type 1 diabetes (T1D) is a life-long condition where the body's immune system (which normally fights infection) mistakenly attacks cells in the pancreas that make insulin. Insulin allows one to use energy from food and controls blood sugar levels. Without early recognition and treatment, high blood sugar can cause serious symptoms and life-threatening complications, such as diabetic ketoacidosis (DKA). DKA happens when there is very low insulin, and if not spotted early, it can cause coma and death. T1D can occur at any age. The chance of getting T1D is higher if another family member has it. T1D progresses silently for months or years before symptoms appear such as increased thirst, frequent urination, and unintentional weight loss. Healthcare providers can now screen and identify people who are at early stages of T1D (without symptoms) with blood tests called autoantibodies. Early detection through screening allows people to 1) learn about the disease before symptoms start and insulin is needed, 2) potentially receive treatments that delay T1D progression, and 3) participate in research trials. By detecting T1D at early stages, people can connect with the right care team and develop the skills needed to manage later stage T1D. Early detection has been shown to prevent hospitalization and life-threatening conditions. Screening for T1D will help people maximize their opportunities to delay T1D onset while preparing for diabetes care.

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.

Towards the standardisation of adult person-reported outcome domains in diabetes research: A Consensus Statement development panel.

Diabetes is unique among chronic diseases because clinical outcomes are intimately tied to how the person living with diabetes reacts to and implements treatment recommendations. It is further characterised by widespread social stigma, judgement and paternalism. This physical, social and psychological burden collectively influences self-management behaviours. It is widely recognised that the individual's perspective about the impact of trying to manage the disease and the burden that self-management confers must be addressed to achieve optimal health outcomes. Standardised, rigorous assessment of mental and behavioural health status, in interaction with physical health outcomes is crucial to aid understanding of person-reported outcomes (PROs). Whilst tempting to conceptualise PROs as an issue of perceived quality of life (QoL), in fact health-related QoL is multi-dimensional and covers indicators of physical or functional health status, psychological and social well-being. This complexity is illuminated by the large number of person reported outcome measures (PROMs) that have been developed across multiple psychosocial domains. Often measures are used inappropriately or because they have been used in the scientific literature rather than based on methodological or outcome assessment rigour. Given the broad nature of psychosocial functioning/mental health, it is important to broadly define PROs that are evaluated in the context of therapeutic interventions, real-life and observational studies. This report summarises the central themes and lessons derived in the assessment and use of PROMs amongst adults with diabetes. Effective assessment of PROMs routinely in clinical research is crucial to understanding the true impact of any intervention. Selecting appropriate measures, relevant to the specific factors of PROs important in the research study will provide valuable data alongside physical health data.

Discordance between mean glucose and time in range in relation to HbA1c in individuals with type 1 diabetes: results from the GOLD and SILVER trials.

AIMS/HYPOTHESIS: Previous studies have shown that individuals with similar mean glucose levels (MG) or percentage of time in range (TIR) may have different HbA1c values. The aim of this study was to further elucidate how MG and TIR are associated with HbA1c. METHODS: Data from the randomised clinical GOLD trial (n=144) and the follow-up SILVER trial (n=98) of adults with type 1 diabetes followed for 2.5 years were analysed. A total of 596 paired HbA1c/continuous glucose monitoring measurements were included. Linear mixed-effects models were used to account for intra-individual correlations in repeated-measures data. RESULTS: In the GOLD trial, the mean age of the participants (± SD) was 44±13 years, 63 (44%) were female, and the mean HbA1c (± SD) was 72±9.8 mmol/mol (8.7±0.9%). When correlating MG with HbA1c, MG explained 63% of the variation in HbA1c (r=0.79, p<0.001). The variation in HbA1c explained by MG increased to 88% (r=0.94, p value for improvement of fit <0.001) when accounting for person-to-person variation in the MG-HbA1c relationship. Time below range (TBR; <3.9 mmol/l), time above range (TAR) level 2 (>13.9 mmol/l) and glycaemic variability had little or no effect on the association. For a given MG and TIR, the HbA1c of 10% of individuals deviated by >8 mmol/mol (0.8%) from their estimated HbA1c based on the overall association between MG and TIR with HbA1c. TBR and TAR level 2 significantly influenced the association between TIR and HbA1c. At a given TIR, each 1% increase in TBR was related to a 0.6 mmol/mol lower HbA1c (95% CI 0.4, 0.9; p<0.001), and each 2% increase in TAR level 2 was related to a 0.4 mmol/mol higher HbA1c (95% CI 0.1, 0.6; p=0.003). However, neither TIR, TBR nor TAR level 2 were significantly associated with HbA1c when accounting for MG. CONCLUSIONS/INTERPRETATION: Inter-individual variations exist between MG and HbA1c, as well as between TIR and HbA1c, with clinically important deviations in relatively large groups of individuals with type 1 diabetes. These results may provide important information to both healthcare providers and individuals with diabetes in terms of prognosis and when making diabetes management decisions.

Understanding suboptimal insulin use in type 1 and 2 diabetes: a cross-sectional survey of healthcare providers who treat people with diabetes.

BACKGROUND: The purpose of this study was to understand the healthcare provider (HCP) perspective on the extent of suboptimal insulin dosing in people with diabetes (PwD), as well as specific challenges and solutions to insulin management. METHODS: An online survey of general practitioners and specialists (N = 640) who treat PwD in Germany, Spain, the United Kingdom, and the United States was conducted. Responses regarding HCP background and their patients, HCP perceptions of suboptimal insulin use, and challenges associated with optimal insulin use were collected. Categorical summary statistics were presented. RESULTS: Overall, for type 1 diabetes (T1D) and type 2 diabetes (T2D), most physicians indicated < 30% of PwD missed or skipped a bolus insulin dose in the last 30 days (T1D: 83.0%; T2D: 74.1%). The top 3 reasons (other than skipping a meal) HCPs believed caused the PwD to miss or skip insulin doses included they "forgot," (bolus: 75.0%; basal: 67.5%) "were too busy/distracted," (bolus: 58.8%; basal: 48.3%), and "were out of their normal routine" (bolus: 57.8%; basal: 48.6%). HCPs reported similar reasons that they believed caused PwD to mistime insulin doses. Digital technology and improved HCP-PwD communication were potential solutions identified by HCPs to optimize insulin dosing in PwD. CONCLUSIONS: Other studies have shown that PwD frequently experience suboptimal insulin dosing. Conversely, results from this study showed that HCPs believe suboptimal insulin dosing among PwD is limited in frequency. While no direct comparisons were made in this study, this apparent discrepancy could lead to difficulties in HCPs giving PwD the best advice on optimal insulin management. Approaches such as improving the objectivity of dose measurements for both PwD and HCPs may improve associated communications and help reduce suboptimal insulin dosing, thus enhancing treatment outcomes.

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.

A novel approach to understanding and assessing the emotional side of type 1 diabetes: The Type 1-Diabetes Distress Assessment System.

AIMS: To describe the development of a novel, conceptually sound instrument with contemporary content for assessing diabetes distress (DD) among adults with type 1 diabetes. METHODS: Qualitative interviews with 15 adults and 7 clinicians were used to develop Core (intensity of DD emotional burden) and primary Source (key DD contributors) items. These were administered to a national sample recruited from the TCOYD Research Registry, T1D Exchange and our previous studies. Exploratory and confirmatory factor analyses were undertaken, along with reliability and construct validity studies, and cut-point analyses to determine elevated DD. RESULTS: Analyses based on 650 respondents yielded an 8-item Core DD scale (α = 0.95) and 10 2- or 3-item DD Source Scales (α range = 0.53-0.88): Financial Worries, Interpersonal Challenges, Management Difficulties, Shame, Hypoglycemia Concerns, Healthcare Quality, Lack of Diabetes Resources, Technology Challenges, Burden to Others and Worries about Complications. Core and Source scores were significantly associated with criterion variables: Higher DD scores were significantly linked with higher HbA1C, more frequent episodes of severe hypoglycaemia, missed boluses, and poorer quality of life (p > 0.001). A ≥2.0 scale cut-point to define elevated DD is suggested. CONCLUSIONS: The new T1-Diabetes Distress Assessment System demonstrated good reliability and validity, and with measures of both Core emotional burden and Sources of DD, it provides a contemporary, flexible and practical approach to assessing DD that can be used seamlessly to inform intervention for clinicians and researchers.

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.

Treatment Satisfaction and Well-Being With CGM in People With T1D: An Analysis Based on the GOLD Randomized Trial.

BACKGROUND: The GOLD trial demonstrated that continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D) managed with multiple daily insulin injections (MDI) improved not only glucose control but also overall well-being and treatment satisfaction. This analysis investigated which factors contributed to improved well-being and treatment satisfaction with CGM. METHODS: The GOLD trial was a randomized crossover trial comparing CGM versus self-monitored blood glucose (SMBG) over 16 months. Endpoints included well-being measured by the World Health Organization-Five Well-Being Index (WHO-5) and treatment satisfaction by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) as well as glucose metrics. Multivariable R2-decomposition was used to understand which variables contributed most to treatment satisfaction. RESULTS: A total of 139 participants were included. Multivariable analyses revealed that increased convenience and flexibility contributed to 60% (95% confidence interval [CI] = 50%-69%) of the improvement in treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire change version [DTSQc]) observed with CGM, whereas perceived effects on hypoglycemia and hyperglycemia only contributed to 6% (95% CI = 2%-11%) of improvements. Significant improvements in well-being (WHO-5) by CGM were observed for the following: feeling cheerful (P = .025), calm and relaxed (P = .024), being active (P = .046), and waking up fresh and rested (P = .044). HbA1c reductions and increased time in range (TIR) were associated with increased treatment satisfaction, whereas glycemic variability was not. HbA1c reduction showed also an association with increased well-being and increased TIR with less diabetes-related distress. CONCLUSIONS: While CGM improves glucose control in people with T1D on MDI, increased convenience and flexibility through CGM is of even greater importance for treatment satisfaction and patient well-being. These CGM-mediated effects should be taken into account when considering CGM initiation.

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.

How Continuous Glucose Monitoring Can Motivate Self-management: Can Motivation Follow Behaviour?

OBJECTIVES: Motivation to adhere to clinical recommendations requires engagement, and the urgency to act is one of many factors that contribute to achieving glycemic benefits in people with type 2 diabetes (PwT2D). Continuous glucose monitoring (CGM) devices are associated with improved glycemic benefits. We conducted a qualitative assessment of PwT2D who found using CGM extremely beneficial and examined the potential for CGM to elicit motivation to engage in self-management behaviours. METHODS: Participants using CGM were recruited through social media and interviewed, and transcripts were analyzed (template analysis using thematic analysis) to generate coded responses and inductive themes by 2 raters. RESULTS: Thirteen participants (84.6% women, with a duration of T2D >5 years and CGM use for >6 months) were interviewed. Codes were organized around 3 themes: improved self-management, experience of glucose-sensing technology vis-à-vis general positive or negative experience, and positive impact of CGM on living with diabetes. Improved self-management was reflected in how the CGM technology provided personalized knowledge and ability to self-manage, particularly in contrast to finger pricking. Positive experience included motivation for behaviour changes as well as improved relationships with health-care providers and in social situations. This translated into a sense of improved health and an avoidance of complications. Negative experience included costs, concern over location of the sensor, and discomfort with the device. CONCLUSIONS: CGM technology profoundly impacts multiple aspects of self-management and care for PwT2D. Developing a validated instrument to assess identified constructs could contribute to developing interventions and leveraging benefits of this technology, particularly the motivational constructs of engagement and urgency.

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.