T1-REDEEM: A Randomized Controlled Trial to Reduce Diabetes Distress Among Adults With Type 1 Diabetes.

OBJECTIVE: To compare the effectiveness of two interventions to reduce diabetes distress (DD) and improve glycemic control among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS: Individuals with T1D (n = 301) with elevated DD and HbA1c were recruited from multiple settings and randomly assigned to OnTrack, an emotion-focused intervention, or to KnowIt, an educational/behavioral intervention. Each group attended a full-day workshop plus four online meetings over 3 months. Assessments occurred at baseline and 3 and 9 months. Primary and secondary outcomes were change in DD and change in HbA1c, respectively. RESULTS: With 12% attrition, both groups demonstrated dramatic reductions in DD (effect size d = 1.06; 78.4% demonstrated a reduction of at least one minimal clinically important difference). There were, however, no significant differences in DD reduction between OnTrack and KnowIt. Moderator analyses indicated that OnTrack provided greater DD reduction to those with initially poorer cognitive or emotion regulation skills, higher baseline DD, or greater initial diabetes knowledge than those in KnowIt. Significant but modest reductions in HbA1c occurred with no between-group differences. Change in DD was modestly associated with change in HbA1c (r = 0.14, P = 0.01), with no significant between-group differences. CONCLUSIONS: DD can be successfully reduced among distressed individuals with T1D with elevated HbA1c using both education/behavioral and emotion-focused approaches. Reductions in DD are only modestly associated with reductions in HbA1c. These findings point to the importance of tailoring interventions to address affective, knowledge, and cognitive skills when intervening to reduce DD and improve glycemic control.

Fixed-ratio combination therapy for type 2 diabetes: the top ten things you should know about insulin and glucagon-like peptide-1 receptor agonist combinations.

Many individuals with type 2 diabetes (T2D) will eventually require insulin therapy to help achieve and maintain adequate glycemic control. However, the use of insulin can be associated with adverse effects such as hypoglycemia and weight gain, and in some patients the addition of insulin to treatment regimens is often still insufficient to achieve target glycemic control. Combining basal insulin with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with T2D has been demonstrated to be effective and well tolerated, while mitigating many of the adverse events associated with giving either of these drug classes alone. Two titratable, fixed-ratio combination therapies, iGlarLixi and IDegLira, that combine basal insulin and a GLP-1 RA in a once-daily subcutaneous injection are currently approved by the US Food and Drug Administration (FDA) for the treatment of patients with T2D. The fixed-ratio combination iGlarLixi combines insulin glargine 100 Units/mL with lixisenatide, while IDegLira combines insulin degludec 100 Units/mL with liraglutide. While these new fixed-ratio combinations contain antihyperglycemic medications that are familiar to most health care providers, there are many questions relating to their use when formulated as a fixed-ratio combination therapy. This article discusses the 'top 10' considerations that health care providers should know about these novel combination therapies as these agents begin to gain an increasing presence in clinical practice.

Emotion regulation contributes to the development of diabetes distress among adults with type 1 diabetes.

OBJECTIVE: To demonstrate how maladaptive emotion regulation (ER) can lead to diabetes distress (DD), with subsequent effects on management and metabolic outcomes among adults with type 1 diabetes. METHODS: Data are based on pre-intervention assessment for a random controlled trial to reduce DD. Patients were recruited in California, Oregon, Arizona and Ontario, Canada. After screening and consent, patients completed an online assessment and released their most recent laboratory HbA1C. Structural equation modeling was used to define an ER measurement model and test for significant pathways. RESULTS: Three ER mechanisms combined into a single construct: emotion processing, non-judgment of emotions, non-reactivity to emotions. Models indicated a significant pathway from ER and cognitions to DD to disease management to metabolic control. CONCLUSIONS: As hypothesized, the three ER mechanisms formed a single, coherent ER construct. Patients with poor ER reported high DD; and high DD was linked to poor diabetes management and poor metabolic control. PRACTICE IMPLICATIONS: Identifying both the level of DD and the ER mechanisms that lead to high DD should be explored in clinical settings. Helping T1Ds to become more aware, less judgmental and less reactive behaviorally to what they feel about diabetes and its management may reduce DD.

Type 2 Diabetes, Hypoglycemia, and Basal Insulins: Ongoing Challenges.

Hypoglycemia in people with insulin-treated type 2 diabetes can be a limiting factor for management and a barrier to optimizing glycemic control. Even mild episodes of hypoglycemia can affect an individual's quality of life, and fear of hypoglycemia can lead to underinsulinization. This article explores the prevalence and consequences of hypoglycemia in people with type 2 diabetes with a focus on those who use basal insulins, offering strategies for prevention and management. It also discusses the benefits and challenges associated with new basal insulins, and their potential role in reducing hypoglycemia risk.

The Contemporary Role of Masked Continuous Glucose Monitoring in a Real-Time World.

Real-time continuous glucose monitoring (RT-CGM) has, in the span of just a few years, established an essential role in the contemporary management of type 1 diabetes. Nonetheless, masked CGM retains an important place in the management of diabetes including assisting with hypoglycemia detection and avoidance, optimizing glycemic control, and acting as a teaching tool for people living with diabetes.

Understanding the sources of diabetes distress in adults with type 1 diabetes.

AIMS: To identify the unique sources of diabetes distress (DD) for adults with type 1 diabetes (T1D). METHODS: Sources of DD were developed from qualitative interviews with 25 T1D adults and 10 diabetes health care providers. Survey items were then developed and analyzed using both exploratory (EFA) and confirmatory CFA) analyses on two patient samples. Construct validity was assessed by correlations with depressive symptoms (PHQ8), complications, HbA1C, BMI, and hypoglycemia worry scale (HWS). Scale cut-points were created using multiple regression. RESULTS: An EFA with 305 U.S. participants yielded 7 coherent, reliable sources of distress that were replicated by a CFA with 109 Canadian participants: Powerlessness, Negative Social Perceptions, Physician Distress, Friend/Family Distress, Hypoglycemia Distress, Management Distress, Eating Distress. Prevalence of DD was high with 41.6% reporting at least moderate DD. Higher DD was reported for women, those with complications, poor glycemic control, younger age, without a partner, and non-White patients. CONCLUSIONS: We identified a profile of seven major sources of DD among T1D using a newly developed assessment instrument. The prevalence of DD is high and is related to glycemic control and several patient demographic and disease-related patient characteristics, arguing for a need to address DD in clinical care.

Biosimilar insulins are coming: the top 10 things you should know.

Biologic drugs, such as currently prescribed insulins, are large, complex, 3-dimensional molecules manufactured in biological systems. The complexity of the structure of the biologic drug and its manufacturing process means that it is challenging to create a biologic drug that is identical to the original branded drug. With the potential availability on the horizon of follow-on insulin products (also known as biosimilar insulins) in the United States and other countries where they are not currently in use, physicians (and other prescribers) need to be aware of the potential benefits and concerns regarding biosimilar insulins in order to facilitate informed decision making and to provide the best possible advice and guidance to their patients with diabetes. This article offers a brief, practical overview regarding biosimilar insulins by answering 10 key questions about the topic.

Diabetes and pregnancy: an endocrine society clinical practice guideline.

OBJECTIVE: Our objective was to formulate a clinical practice guideline for the management of the pregnant woman with diabetes. PARTICIPANTS: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, 5 additional experts, a methodologist, and a medical writer. EVIDENCE: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. CONSENSUS PROCESS: One group meeting, several conference calls, and innumerable e-mail communications enabled consensus for all recommendations save one with a majority decision being employed for this single exception. CONCLUSIONS: Using an evidence-based approach, this Diabetes and Pregnancy Clinical Practice Guideline addresses important clinical issues in the contemporary management of women with type 1 or type 2 diabetes preconceptionally, during pregnancy, and in the postpartum setting and in the diagnosis and management of women with gestational diabetes during and after pregnancy.

Using multiple measures of glycemia to support individualized diabetes management: recommendations for clinicians, patients, and payers.

By the year 2030, the diabetes pandemic will likely affect more than 10% of the world's population. The personal, public health, and economic crises implicit in this trend call for decisive action. Yet, escalating dilemmas thwart full realization of current therapies. First, controversial studies, such as the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial, have amplified calls to individualize glycated hemoglobin (A1C) targets in the absence of adequate infrastructures for supporting personalized care. Second, costlier medications and technologies addressing more nuanced aspects of metabolic dysfunction are expanding options for diabetes management amidst growing disparities between "affordable" and "best" care. Third, common clinical quandaries, such as discrepancies between A1C and self-monitoring of blood glucose data, as well as misconceptions about long-term glycemic assessment, compound entrenched cycles of inadequate self-care, delayed intervention, and suboptimal glycemic outcomes. Because individual, clinical, and public policy responses to these conflicting forces are based largely on methodologies for glucose measurement, a panel of clinical experts from Europe and North America was convened to reexamine our glucose measuring tools and determine ways in which they can be better applied toward more purposeful processes of glycemic management. Among the main issues addressed were the need for caution in interpreting A1C for individual patients, the role of alternative biomarkers in identifying aspects of glycemic dysregulation not captured by A1C, and the value of using patients' own glucose data to consolidate therapeutic, educational, and behavior-change objectives.

Breastfeeding predicts the risk of childhood obesity in a multi-ethnic cohort of women with diabetes.

OBJECTIVE: To determine whether breastfeeding reduced the risk of childhood obesity in the infants of a multi-ethnic cohort of women with pregestational diabetes. METHODS: In this retrospective cohort study, women with pregestational diabetes were mailed a questionnaire about breastfeeding and current height and weight of mothers and infants. Predictors of obesity (weight for age >85 percentile) were assessed among offspring of index pregnancies, using univariate and multivariable logistic regression. RESULTS: Of 125 women, 81 (65%) had type 1 diabetes and 44 (35%) had type 2 diabetes. The mean age of offspring was 4.5 years. On univariate analysis, significant predictors of obesity in offspring were type 2 diabetes (odds ratio, OR 2.4, 95% confidence interval, CI 0.99-5.72); maternal body mass index (BMI)>25 (OR 4.4, 95% CI 1.4-19.4); and any breastfeeding (OR 0.22, 95% CI 0.07-0.72). After multivariable adjustment, breastfeeding (OR 0.20, 95% CI 0.06-0.69) and having an overweight/obese mother (OR 3.49, 95% CI 1.03-16.2) remained independently associated with childhood obesity. CONCLUSION: Breastfeeding significantly decreased the likelihood of obesity in offspring of mothers with pregestational diabetes, independent of maternal BMI and diabetes type. Women with diabetes should be encouraged to breastfeed, given the increased risk of obesity in their children.