Patient Perspectives on the Benefits and Challenges of Diabetes and Digital Technology.

Diabetes technology continues to evolve, advancing with our understanding of human biology and improving our ability to treat people with diabetes. Diabetes devices are broadly classified into the following categories: glucose sensors, insulin delivery devices, and digital health care technology (i.e., software and mobile applications). When supported by education and individually tailored, technology can play a key role in optimizing outcomes. Digital devices assist in diabetes management by tracking meals, exercise, sleep, and glycemic measurements in real time, all of which can guide physicians and other clinicians in their decision-making. Here, as people with diabetes and patient advocates, as well as diabetes specialists, primary care providers, and diabetes care and education specialists, we present our perspectives on the advances, benefits, and challenges of diabetes technology in primary care practices.

Person-first language in diabetes and obesity scientific publications.

AIMS: We aimed to quantify the use of person-first language (PFL) among scholarly articles focusing on diabetes or obesity. METHODS: PFL and condition-first language (CFL) terms for diabetes and obesity (e.g. diabetic, obese) were identified from existing guidelines and a review of the literature. Exact phrase literature searches were conducted between 2011 and 2020 and results were categorised as PFL, CFL or both. RESULTS: Among diabetes articles, 43% used PFL, 40% used CFL and 17% contained both. Among obesity articles, 0.5% used PFL, 99% used CFL and 0.2% used both. The use of PFL increased by 3% per year for diabetes articles, compared to 117% for obesity articles. The rate of adoption of PFL in diabetes articles was unchanged in 2018-2020 compared to the 3 years prior. CONCLUSIONS: While the use of person-first language in diabetes articles had increased over the review period, its rate of adoption has started to slow. Conversely, the use of PFL in obesity articles is nascent and increasing.

Patient-reported outcomes in adults with type 1 diabetes in global real-world clinical practice: The SAGE study.

AIMS: To conduct a secondary analysis of the SAGE study to evaluate the association between glycaemic control and patient-reported outcomes (PROs), in adults with type 1 diabetes (T1DM) across different age groups and regions. MATERIALS AND METHODS: SAGE was a multinational, cross-sectional, observational study in adults with T1DM. Data were collected at a single visit, analysed according to predefined age groups (26-44, 45-64, and ≥65 years), and reported across different regions. PRO questionnaires were applied to assess hypoglycaemia fear (Hypoglycemia Fear Survey-II), diabetes-related distress (Problem Areas In Diabetes questionnaire), insulin treatment satisfaction (Insulin Treatment Satisfaction Questionnaire), and diabetes-specific quality of life (QoL; Audit of Diabetes-Dependent Quality of Life). Multivariable analysis was performed to evaluate the relationship between glycated haemoglobin (HbA1c) target achievement (<7% and individualised targets) with PRO scores. RESULTS: The PRO scores showed relatively low levels of diabetes-related emotional distress and fear of hypoglycaemia, moderate to high treatment satisfaction, and low diabetes-related impact on QoL. Results were generally comparable across age groups with some regional variability. Achievement of the HbA1c <7% target was associated with less worry about hypoglycaemia, lower diabetes-related emotional distress, higher insulin treatment satisfaction, and higher QoL. Achievement of individualised HbA1c targets was associated with lower diabetes-related emotional distress and higher insulin treatment satisfaction. CONCLUSIONS: Better glycaemic control was most closely associated with low emotional distress due to diabetes and high patient-reported insulin treatment satisfaction.

Comparison of Protocols to Reduce Diabetic Ketoacidosis in Patients With Type 1 Diabetes Prescribed a Sodium-Glucose Cotransporter 2 Inhibitor.

OBJECTIVE | Sodium-glucose cotransporter 2 (SGLT2) inhibitors are approved for type 1 diabetes in Europe and Japan, with off-label use in type 1 diabetes in the United States. Although there were no consistent approaches to risk mitigation in clinical trials of these agents, protocols have been developed to try to reduce the risk of diabetic ketoacidosis (DKA). However, a validated risk mitigation strategy does not exist. We reviewed available DKA risk mitigation protocols to better understand the various strategies currently in use. METHODS | We conducted a search of the published medical literature and other medical information sources, including conference presentations, for protocols. We then categorized the information provided into guidance on patient selection, initiation of SGLT2 inhibitors, ketone monitoring, necessary patient action in the event of ketosis or DKA, and inpatient treatment of ketosis or DKA. RESULTS | Patient selection is generally similar among the protocols, although some require a minimum BMI and insulin dose. All protocols advocate routine measurement of ketones, although some insist on blood ketone tests. Although action steps for ketosis varies, all protocols advocate rapid patient intervention. The importance of evaluating ketones and acid-base balance even in the absence of hyperglycemia is emphasized by all protocols, as is the need to continue administering insulin until ketosis has resolved. CONCLUSION | DKA risk mitigation must be pursued systematically in individuals with type 1 diabetes, although the best strategy remains to be determined. Given the ongoing need for adjunctive therapies in type 1 diabetes and current use of SGLT2 inhibitors for this purpose, additional education and research are crucial, especially in the hospital environment, where DKA may not be diagnosed promptly and treated appropriately.

Continuous Glucose Monitoring Use in Clinical Trials for On-Market Diabetes Drugs.

To the best of our knowledge, there are no published data on the historical and recent use of CGM in clinical trials of pharmacological agents used in the treatment of diabetes. We analyzed 2,032 clinical trials of 40 antihyperglycemic therapies currently on the market with a study start date between 1 January 2000 and 31 December 2019. According to ClinicalTrials.gov, 119 (5.9%) of these trials used CGM. CGM usage in clinical trials has increased over time, rising from <5% before 2005 to 12.5% in 2019. However, it is still low given its inclusion in the American Diabetes Association's latest guidelines and known limitations of A1C for assessing ongoing diabetes care.

Automated Insulin Delivery: Easy Enough to Use in Primary Care?

There are three automated insulin delivery devices on the U.S. market, two of which are currently approved by the U.S. Food and Drug Administration. These systems have already made a significant impact for the people who use them in improving diabetes outcomes, including glycemic control and hypoglycemia prevention. This article aims to help primary care and endocrinology providers better understand the components, differences, limitations, and potential fit of these systems into clinical practice.

How Does Diabetes Affect Daily Life? A Beyond-A1C Perspective on Unmet Needs.

IN BRIEF Given the progressive nature of type 2 diabetes, treatment intensification is usually necessary to maintain glycemic control. However, for a variety of reasons, treatment is often not intensified in a timely manner. The combined use of basal insulin and a glucagon-like peptide-1 receptor agonist is recognized to provide a complementary approach to the treatment of type 2 diabetes. This review evaluates the efficacy and safety of two co-formulation products, insulin degludec/liraglutide and insulin glargine/lixisenatide, for the treatment of type 2 diabetes inadequately controlled on either component agent alone. We consider the benefits and limitations of these medications based on data from randomized clinical trials and discuss how they may address barriers to treatment intensification.

Does Time-in-Range Matter? Perspectives From People With Diabetes on the Success of Current Therapies and the Drivers of Improved Outcomes.

IN BRIEF After assessing patient perspectives on the success of current diabetes therapies and the factors that have the greatest impact on daily life, we show that time-in-range is a crucial outcome for people with diabetes and that current therapies are falling short on this metric. We also show that patients feel significant stress and worry, and they believe they are falling short in diet, exercise, and weight maintenance. In addition, they believe diet and exercise and in-range blood glucose are the biggest drivers of improved diabetes management and mindset. Together, these findings support the need for therapies that improve outcomes including and beyond A1C.

Erratum: Stigma in People With Type 1 or Type 2 Diabetes. Clinical Diabetes 2017;35:27-34. DOI: 10.2337/cd16-0020.

[This corrects the article on p. 27 in vol. 35, PMID: 28144043.].

Stigma in People With Type 1 or Type 2 Diabetes.

IN BRIEF This study quantitatively measures diabetes stigma and its associated psychosocial impact in a large population of U.S. patients with type 1 or type 2 diabetes using an online survey sent to 12,000 people with diabetes. A majority of respondents with type 1 (76%) or type 2 (52%) diabetes reported that diabetes comes with stigma. Perceptions of stigma were significantly higher among respondents with type 1 diabetes than among those with type 2 diabetes, with the highest rate in parents of children with type 1 diabetes (83%) and the lowest rate in people with type 2 diabetes who did not use insulin (49%). Our results suggest that a disturbingly high percentage of people with diabetes experience stigma, particularly those with type 1 or type 2 diabetes who are on intensive insulin therapy. The experience of stigma disproportionately affects those with a higher BMI, higher A1C, and poorer self-reported blood glucose control, suggesting that those who need the most help are also the most affected by stigma.

A Commentary on Pediatric Oral Health in North Carolina.

Pediatric oral health care in North Carolina has taken a unique path to its current form and will require similar innovation to counter headwinds to its continued success. This commentary describes that path and attempts to set a vision and strategy for the future that leverages Community Care of North Carolina's infrastructure and continues to promote the expansion of clinical guidelines for pediatric preventive oral health care for vulnerable populations.

More Than 7 Years of Hindsight: Revisiting the FDA's 2008 Guidance on Cardiovascular Outcomes Trials for Type 2 Diabetes Medications.

IN BRIEF Concerns raised about the cardiovascular safety of type 2 diabetes medications such as rosiglitazone prompted the U.S. Food and Drug Administration to issue draft guidance in 2008 that, in practice, has required large cardiovascular outcomes trials (CVOTs) for all new type 2 diabetes therapies. After more than 7 years and six completed and published trials to date, this is an opportune time to consider whether these studies, as currently designed and conducted, accurately assess the long-term benefit/risk profile of new therapies and whether they represent an optimal use of limited health care resources. This article presents and contextualizes opinions on CVOTs from 10 thought leaders in diabetes. It is intended to inform an exploration of the costs, medical ethics, and effectiveness of using large-scale CVOTs to assess the safety of new diabetes therapies.

Challenges in Diabetes Care: Can Digital Health Help Address Them?

In Brief There is great enthusiasm for the potential of digital health solutions in medicine and diabetes to address key care challenges: patient and provider burden, lack of data to inform therapeutic decision-making, poor access to care, and costs. However, the field is still in its nascent days; many patients and providers do not currently engage with digital health tools, and for those who do, the burden is still often high. Over time, digital health has excellent potential to collect data more seamlessly, make collected data more useful, and drive better outcomes at lower costs in less time. But there is still much to prove. This review offers key background information on the current state of digital health in diabetes, six of the most promising digital health technologies and services, and the challenges that remain.

From Individuals to International Policy: Achievements and Ongoing Needs in Diabetes Advocacy.

Diabetes impacts tens of millions of people in the United States of America and 9 % of the worldwide population. Given the public health implications and economic burden of diabetes, the needs of people with diabetes must be addressed through strategic and effective advocacy efforts. Diabetes advocacy aims to increase public awareness about diabetes, raise funds for research and care, influence policy impacting people with diabetes, and promote optimal individual outcomes. We present a framework for diabetes advocacy activities by individuals and at the community, national, and international levels and identify challenges and gaps in current diabetes advocacy. Various groups have organized successful diabetes advocacy campaigns toward these goals, and lessons for further advancing diabetes advocacy can be learned from other health-related populations. Finally, we discuss the role of healthcare providers and mental/behavioral health professionals in advocacy efforts that can benefit their patients and the broader population of people with diabetes.

A cluster-randomized trial determining the efficacy of caterpillar cereal as a locally available and sustainable complementary food to prevent stunting and anaemia.

OBJECTIVE: We conducted a cluster-randomized controlled trial to assess the efficacy of a cereal made from caterpillars, a micronutrient-rich, locally available alternative animal-source food, on reducing stunting and anaemia in infants in the Democratic Republic of Congo. DESIGN: Six-month-old infants were cluster randomized to receive either caterpillar cereal daily until 18 months of age or the usual diet. At 18 months of age, anthropometric measurements and biological samples were collected. SETTING: The rural Equateur Province in the Democratic Republic of Congo. SUBJECTS: One hundred and seventy-five infants followed from 6 to 18 months of age. RESULTS: Stunting was common at 6 months (35%) and the prevalence increased until 18 months (69%). There was no difference in stunting prevalence at 18 months between the intervention and control groups (67% v. 71%, P = 0.69). Infants in the cereal group had higher Hb concentration than infants in the control group (10.7 v. 10.1 g/dl, P = 0.03) and fewer were anaemic (26 v. 50%, P = 0.006), although there was no difference in estimates of body Fe stores (6.7 v. 7.2 mg/kg body weight, P = 0.44). CONCLUSIONS: Supplementation of complementary foods with caterpillar cereal did not reduce the prevalence of stunting at 18 months of age. However, infants who consumed caterpillar cereal had higher Hb concentration and fewer were anaemic, suggesting that caterpillar cereal might have some beneficial effect. The high prevalence of stunting at 6 months and the lack of response to this micronutrient-rich supplement suggest that factors other than dietary deficiencies also contribute to stunting.

Prioritizing Patient Experiences in the Management of Diabetes and Its Complications: An Endocrine Society Position Statement.

Diabetes can be an arduous journey both for people with diabetes (PWD) and their caregivers. While the journey of every person with diabetes is unique, common themes emerge in managing this disease. To date, the experiences of PWD have not been fully considered to successfully implement the recommended standards of diabetes care in practice. It is critical for health-care providers (HCPs) to recognize perspectives of PWD to achieve optimal health outcomes. Further, existing tools are available to facilitate patient-centered care but are often underused. This statement summarizes findings from multistakeholder expert roundtable discussions hosted by the Endocrine Society that aimed to identify existing gaps in the management of diabetes and its complications and to identify tools needed to empower HCPs and PWD to address their many challenges. The roundtables included delegates from professional societies, governmental organizations, patient advocacy organizations, and social enterprises committed to making life better for PWD. Each section begins with a clinical scenario that serves as a framework to achieve desired health outcomes and includes a discussion of resources for HCPs to deliver patient-centered care in clinical practice. As diabetes management evolves, achieving this goal will also require the development of new tools to help guide HCPs in supporting PWD, as well as concrete strategies for the efficient uptake of these tools in clinical practice to minimize provider burden. Importantly, coordination among various stakeholders including PWD, HCPs, caregivers, policymakers, and payers is critical at all stages of the patient journey.

Continuous glucose monitoring and metrics for clinical trials: an international consensus statement.

Randomised controlled trials and other prospective clinical studies for novel medical interventions in people with diabetes have traditionally reported HbA1c as the measure of average blood glucose levels for the 3 months preceding the HbA1c test date. The use of this measure highlights the long-established correlation between HbA1c and relative risk of diabetes complications; the change in the measure, before and after the therapeutic intervention, is used by regulators for the approval of medications for diabetes. However, with the increasing use of continuous glucose monitoring (CGM) in clinical practice, prospective clinical studies are also increasingly using CGM devices to collect data and evaluate glucose profiles among study participants, complementing HbA1c findings, and further assess the effects of therapeutic interventions on HbA1c. Data is collected by CGM devices at 1-5 min intervals, which obtains data on glycaemic excursions and periods of asymptomatic hypoglycaemia or hyperglycaemia (ie, details of glycaemic control that are not provided by HbA1c concentrations alone that are measured continuously and can be analysed in daily, weekly, or monthly timeframes). These CGM-derived metrics are the subject of standardised, internationally agreed reporting formats and should, therefore, be considered for use in all clinical studies in diabetes. The purpose of this consensus statement is to recommend the ways CGM data might be used in prospective clinical studies, either as a specified study endpoint or as supportive complementary glucose metrics, to provide clinical information that can be considered by investigators, regulators, companies, clinicians, and individuals with diabetes who are stakeholders in trial outcomes. In this consensus statement, we provide recommendations on how to optimise CGM-derived glucose data collection in clinical studies, including the specific glucose metrics and specific glucose metrics that should be evaluated. These recommendations have been endorsed by the American Association of Clinical Endocrinologists, the American Diabetes Association, the Association of Diabetes Care and Education Specialists, DiabetesIndia, the European Association for the Study of Diabetes, the International Society for Pediatric and Adolescent Diabetes, the Japanese Diabetes Society, and the Juvenile Diabetes Research Foundation. A standardised approach to CGM data collection and reporting in clinical trials will encourage the use of these metrics and enhance the interpretability of CGM data, which could provide useful information other than HbA1c for informing therapeutic and treatment decisions, particularly related to hypoglycaemia, postprandial hyperglycaemia, and glucose variability.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

BACKGROUND: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. METHODS: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. RESULTS: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. CONCLUSION: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Consensus Recommendations for the Use of Automated Insulin Delivery Technologies in Clinical Practice.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers, and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past 6 years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Pediatricians' assessments of caries risk and need for a dental evaluation in preschool aged children.

BACKGROUND: Risk-based prioritization of dental referrals during well-child visits might improve dental access for infants and toddlers. This study identifies pediatrician-assessed risk factors for early childhood caries (ECC) and their association with the need for a dentist's evaluation. METHODS: A priority oral health risk assessment and referral tool (PORRT) for children < 36 months was developed collaboratively by physicians and dentists and used by 10 pediatricians during well-child visits. PORRT documented behavioral, clinical, and child health risks for ECC. Pediatricians also assessed overall ECC risk on an 11-point scale and determined the need for a dental evaluation. Logistic regression models calculated the odds for evaluation need for each risk factor and according to a 3-level risk classification. RESULTS: In total 1,288 PORRT forms were completed; 6.8% of children were identified as needing a dentist evaluation. Behavioral risk factors were prevalent but not strong predictors of the need for an evaluation. The child's overall caries risk was the strongest predictor of the need for an evaluation. Cavitated (OR = 17.5; 95% CI = 8.08, 37.97) and non-cavitated (OR = 6.9; 95% CI = 4.47, 10.82) lesions were the strongest predictors when the caries risk scale was excluded from the analysis. Few patients (6.3%) were classified as high risk, but their probability of needing an evaluation was only 0.36. CONCLUSIONS: Low referral rates for children with disease and prior to disease onset but at elevated risk, indicate interventions are needed to help improve the dental referral rates of physicians.