Early type 2 diabetes treatment intensification with glucagon-like peptide-1 receptor agonists in primary care: An Australian perspective on guidelines and the global evidence.

Early and intensive management of type 2 diabetes has been shown to delay disease progression, reduce the risk of cardiorenal complications and prolong time to treatment failure. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are being increasingly recognized for their potential in early disease management, with recent guideline updates recommending second-line use of this injectable drug class alongside oral glucose-lowering drugs. GLP-1RAs target at least six of the eight core defects implicated in the pathogenesis of type 2 diabetes and offer significant glycaemic and weight-related improvements over other second-line agents in head-to-head trials. In addition, placebo-controlled clinical trials have shown cardiovascular protection with GLP-1RA use. Even so, this therapeutic class is underused in primary care, largely owing to clinical inertia and patient-related barriers to early intensification with GLP-1RAs. Fortunately, clinicians can overcome barriers to treatment acceptance through patient education and training, and management of treatment expectations. In this review we comment on global and Australian guideline updates and evidence in support of early intensification with this therapeutic class, and provide clinicians with practical advice for GLP-1RA use in primary care.

Utilisation, access and recommendations regarding technologies for people living with type 1 diabetes: consensus statement of the ADS/ADEA/APEG/ADIPS Working Group.

INTRODUCTION: Type 1 diabetes presents significant challenges for optimal management. Despite intensive glycaemic control being the standard of care for several decades, glycaemic targets are infrequently achieved and the burden of complications remains high. Therefore, the advancement of diabetes management technologies has a major role in reducing the clinical and economic impact of the disease on people living with type 1 diabetes and on health care systems. However, a national framework is needed to ensure equitable and sustainable implementation of these technologies as part of holistic care. MAIN RECOMMENDATIONS: This consensus statement considers technologies for insulin delivery, glucose sensing and insulin dose advice that are commercially available in Australia. While international position statements have provided recommendations for technology implementation, the ADS/ADEA/APEG/ADIPS Working Group believes that focus needs to shift from strict trial-based glycaemic criteria towards engagement and individualised management goals that consider the broad spectrum of benefits offered by technologies. CHANGES IN MANAGEMENT AS RESULT OF THIS STATEMENT: This Australian consensus statement from peak national bodies for the management of diabetes across the lifespan outlines a national framework for the optimal implementation of technologies for people with type 1 diabetes. The Working Group highlights issues regarding equity of access to technologies and services, scope of clinical practice, credentialling and accreditation requirements, regulatory issues with "do-it-yourself" technology, national benchmarking, safety reporting, and ongoing patient advocacy.

Effect of High-Intensity Interval Training on Glycemic Control in Adults With Type 1 Diabetes and Overweight or Obesity: A Randomized Controlled Trial With Partial Crossover.

OBJECTIVE: To study the effect of 12 weeks of high-intensity interval training (HIIT) on glycemic control in adults with type 1 diabetes and overweight or obesity. RESEARCH DESIGN AND METHODS: Thirty inactive adults with type 1 diabetes who had BMI ≥25 kg/m2 and HbA1c ≥7.5% were randomized to 12 weeks of either HIIT exercise intervention consisting of 4 × 4-min HIIT (85-95% peak heart rate) performed thrice weekly or usual care control. In a partial crossover design, the control group subsequently performed the 12-week HIIT intervention. The primary end point was the change in HbA1c from baseline to 12 weeks. Glycemic and cardiometabolic outcomes were measured at 0, 12, and 24 weeks. RESULTS: Participants were aged 44 ± 10 years with diabetes duration 19 ± 11 years and BMI 30.1 ± 3.1 kg/m2. HbA1c decreased from 8.63 ± 0.66% at baseline to 8.10 ± 1.04% at 12 weeks in the HIIT intervention group (P = 0.01); however, this change was not significantly different from the control group (HIIT -0.53 ± 0.61%, control -0.14 ± 0.48%, P = 0.08). In participants who undertook at least 50% of the prescribed HIIT intervention, the HbA1c reduction was significantly greater than control (HIIT -0.64 ± 0.64% [n = 9], control -0.14 ± 0.48% [n = 15], P = 0.04). There were no differences in insulin dose, hypoglycemia on continuous glucose monitoring, blood pressure, blood lipids, body weight, or body composition between groups. CONCLUSIONS: Overall, there was no significant reduction in HbA1c with a 12-week HIIT intervention in adults with type 1 diabetes. However, glycemic control may improve for people who undertake HIIT with greater adherence.

An on-line support tool to reduce exercise-related hypoglycaemia and improve confidence to exercise in type 1 diabetes.

OBJECTIVE: Hypoglycaemia related to exercise and lack of confidence to exercise, are common in T1DM. An online educational exercise tool (ExT1D) was tested to determine whether these parameters can be improved. RESEARCH DESIGN AND METHODS: Thirty two adults with T1DM (50%M, age 35.8 ±â€¯9.5 yr diabetes duration 12.3 ±â€¯9.9 yr, median HbA1c 7.1%[ICR 6.4-7.7] NGSPU) exercising ≥ 60 min/week enrolled in a RCT utilising ExT1D, with partial cross-over design. The primary end-point was Exercise-related hypoglycaemia (ErH) number corrected for exercise session number, with ErH defined as CGM episodes < 4.0 mM occurring within 24 h of exercise. Secondary RCT endpoints were total ErH duration, and ErH duration/episode. A pre-defined longitudinal analysis with each subject compared with their baseline was also undertaken, for the three ErH parameters, and using fear of hypoglycaemia questionnaires. RESEARCH: In the RCT a 50% lower median ErH number (P = 0.6) (37% lower ErH number per exercise session (P = 0.06, NS primary endpoint) occurred in the Intervention vs Control group. A 49% lower ErH duration per episode (P = 0.2), and 80% less ErH duration (P = 0.3), were also observed in the Intervention vs Control group. In the longitudinal study, ErH number reduced by 43% (P = 0.088), ErH duration per episode by 52% (P = 0.157) and total duration of ErH fell by 71% (P = 0.015). Confidence to prevent glucose lowering by exercise also improved (P = 0.039). Post-hoc analysis showed those with the greatest ErH events at baseline benefited most. Fructosamine and HbA1c levels were unchanged from baseline. CONCLUSIONS: ExT1D can reduce exercise-related hypoglycaemia and provide greater confidence to exercise.

Use of 50/50 Premixed Insulin Analogs in Type 2 Diabetes: Systematic Review and Clinical Recommendations.

INTRODUCTION: Premixed insulin analogs represent an alternative to basal or basal-bolus insulin regimens for the treatment of type 2 diabetes (T2D). "Low-mix" formulations with a low rapid-acting to long-acting analog ratio (e.g., 25/75) are commonly used, but 50/50 formulations (Mix50) may be more appropriate for some patients. We conducted a systematic literature review to assess the efficacy and safety of Mix50, compared with low-mix, basal, or basal-bolus therapy, for insulin initiation and intensification. METHODS: MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, ClinicalTrials.gov, LillyTrials.com, and NovoNordisk-trials.com were searched (11 or 13 Dec 2016) using terms for T2D, premixed insulin analogs, and/or Mix50. Studies (randomized, nonrandomized, or observational; English only) comparing Mix50 with other insulins (except human) and reporting key efficacy [glycated hemoglobin (HbA1c), fasting and postprandial glucose] and/or safety (hypoglycemia, weight gain) outcomes were eligible for inclusion. Narrative reviews, letters, editorials, and conference abstracts were excluded. Risk of bias in randomized trials was assessed using the Cochrane tool. RESULTS: MEDLINE and EMBASE searches identified 716 unique studies, of which 32 met inclusion criteria. An additional three studies were identified in the other databases. All 19 randomized trials except one were open label; risk of other biases was generally low. Although not conclusive, the evidence suggests that Mix50 may provide better glycemic control (HbA1c reduction) and, particularly, postprandial glucose reduction in certain patients, such as those with high carbohydrate diets and Asian patients, than low-mix and basal therapy. Based on this evidence and our experience, we provide clinical guidance on factors to consider when deciding whether Mix50 is appropriate for individual patients. CONCLUSIONS: Mix50 may be more suitable than low-mix therapy for certain patients. Clinicians should consider not only efficacy and safety but also patient characteristics and preferences when tailoring insulin treatment to individuals with T2D. FUNDING: Eli Lilly.

Severe Hypoglycemia and the Role of the Significant Other: Expert, Sentry, and Protector.

PURPOSE: The purpose of the study was to gain a better understanding of what severe hypoglycemia means to significant others. METHODS: Narrative inquiry methodology was utilized. In-depth interviews were conducted with 7 significant others of adults with type 1 diabetes about their experience with severe hypoglycemia. Interviews were recorded, transcribed verbatim, and then developed into narrated core stories through a process of selecting and organizing events and by describing the relationship among these events. This was followed by thematic analysis to reveal the shared narrative of significant others. RESULTS: Episodes of severe hypoglycemia were found to turn the participants' lives upside down. The inability of the individual with diabetes to manage severe hypoglycemia required the significant other to detect and treat these episodes. The theme "managing disruption" captured how the significant others' role shifted from one of background support to an active, primary role in severe hypoglycemia management. They became (1) the expert by arming themselves with knowledge and skills to assist with the severe hypoglycemia episodes, (2) the sentry by becoming more vigilant and prepared for these episodes, and (3) the protector of the person with diabetes by shielding him or her from the vulnerable position that the severe hypoglycemia episodes placed one in. CONCLUSIONS: This study highlights the important role that significant others play in the management of severe hypoglycemia. It also emphasizes the need for health care professionals to provide appropriate education and support.

Improving Self-Monitoring of Blood Glucose among Adults with Type 1 Diabetes: Results of the Mobile™ Study.

INTRODUCTION: The objective of this study was to determine whether people with type 1 diabetes are more likely to self-monitor their blood glucose (SMBG) as recommended by their diabetes health care professional using the Accu-Chek Mobile™ (F. Hoffmann-La Roche AG, Basel, Switzerland) monitoring system compared to the Freestyle Optium™ (Abbott, North Chicago, IL, USA). METHODS: Thirty-five participants with type 1 diabetes participating in a randomized cross-over study were assigned to monitor their blood glucose levels for a 3-month period using the Accu-Chek Mobile or the Freestyle Optium monitoring system and then to cross-over to the alternative device. After completion of the 6-month cross-over period, participants were invited to select their meter of choice and were followed for a further 3 months. RESULTS: SMBG frequency increased in both groups but participants monitored significantly more often using the Accu-Chek Mobile meter (frequency SMBG/week median: 19 vs. 10, P = 0.04). After 3 months using each meter, 77% of participants indicated a preference for the Accu-Chek Mobile meter. Monitoring frequency in this group remained higher than baseline during the 3-month post-cross-over follow-up period. CONCLUSION: Our results indicate that the Accu-Chek Mobile meter improves SMBG frequency. After experience of both systems, Accu-Chek Mobile was the meter of choice for the majority of participants in this study. FUNDING: Roche Diabetes Care Unconditional Education Grant.

Glycemic control and blood glucose monitoring over time in a sample of young Australians with type 1 diabetes: the role of personality.

OBJECTIVE: To determine whether personality traits (conscientiousness, agreeableness, emotional regulation, extraversion, and openness to experience) are associated with glycemic control and blood glucose monitoring behavior, and change or stability of these outcomes over time, in young people with type 1 diabetes. RESEARCH DESIGN AND METHODS: A 3-year longitudinal study was conducted using data from 142 individuals with type 1 diabetes, 8-19 years of age. Personality was assessed at baseline using the Five-Factor Personality Inventory for Children. Data relating to glycemic control (HbA1c) and frequency of blood glucose monitoring (based on meter memory) were collected annually. Relationships between personality traits and HbA1c and monitoring frequency were examined using regression models and mixed-design ANOVA. RESULTS: Three of the Five-Factor domains were independently associated with glycemic control. Individuals high in conscientiousness and agreeableness had a lower and more stable HbA1c across the 3-year study period. In contrast, the HbA1c of individuals scoring low on these traits was either consistently worse or deteriorated over time. Low or high emotional regulation scores were also associated with worse glycemic control. By the third year, these domains, together with initial HbA1c, accounted for 39% of HbA1c variance. Conscientiousness was the only personality factor associated with blood glucose monitoring behavior. CONCLUSIONS: Results of this study underline the importance of personality in contributing to diabetes outcomes. Attention to a young person's personality, and appropriate tailoring of diabetes management to ensure an individualized approach, may help to optimize diabetes outcomes.

Application of Australian clinical management guidelines: the current state of play in a sample of young people living with Type 1 diabetes in the state of New South Wales and the Australian Capital Territory.

AIMS: To describe care provided to a sample of young Australians with Type 1 diabetes, and benchmark this against national guidelines. METHODS: 158 children and adolescents with Type 1 diabetes, aged 8-19 years, were recruited independent of their source of care as part of a three-year longitudinal study. Data were gathered annually regarding type of health-care services attended, demographic, health-care and self-care information. Participants were also telephoned quarterly to ascertain planned and actual attendance to diabetes services, and current diabetes management. A capillary sample was collected annually for HbA1c determination. RESULTS: The mean HbA1c of participants was significantly higher than recommended levels. The annual number of visits to diabetes clinics also fell short of the stipulated 3-4 visits a year and less than 25% of participants received care from all recommended multidisciplinary team members. While the majority of care was provided through the publicly funded system, there was an increasing reliance on privately funded psychologists. CONCLUSION: Standards of care received by this group of young Australians and levels of glycaemic control fall short of treatment guidelines, highlighting the need to identify ways to ensure equitable access to specialist multidisciplinary care for all young people affected by diabetes.

Glycemic control and type 1 diabetes: the differential impact of model of care and income.

OBJECTIVE: To examine the effect of model of care (specialist care vs. shared care), and income, on glycemic control in a sample of young people with type 1 diabetes. METHODS: A total of 158 children and young people with type 1 diabetes, aged 8-19 yr, and their families, were recruited independent of their source of care as part of a longitudinal, cross-sectional exploratory study. At enrollment, participants completed a series of questionnaires and underwent a structured interview to gather data regarding the type of specialist and healthcare services attended, as well as demographic, healthcare, and self-care information. Capillary sample was taken for HbA1c determination. RESULTS: The mean HbA1c for the group as a whole was 8.6 ± 1.4%. There was no effect for model of care on glycemic control. However, young people living in households with a family income of less than AUS$83,000 (US$73,500) per year had a significantly higher mean HbA1c than their counterparts reporting a higher household income (8.8 ± 1.4% vs. 8.3 ± 1.1%; p = 0.019). CONCLUSION: Although no differences were found with respect to the short-term impact of specialist vs. shared care, it is evident that more support is required to improve glycemic control in this sample of young people where the mean level of HbA1c was significantly higher than target. Further research is also indicated to determine the relationship between glycemic control and socioeconomic status.

Social disadvantage: its impact on the use of Medicare services related to diabetes in NSW.

OBJECTIVE: To use Medicare data to examine the impact of social disadvantage on the use of health services related to diabetes. METHOD: Information on number of diabetic individuals and number of services for select Medicare item codes were retrieved by New South Wales postcodes using a Health Insurance Commission data file. The postcodes were graded into quintiles of social disadvantage. RESULTS: People at most social disadvantage were significantly less likely to be under the care of a general practitioner (adjusted OR 0.41; 95% CI 0.40-0.41) or consultant physician (adjusted OR 0.50; 95% CI 0.48-0.53), despite this group having the highest prevalence of diabetes. The difference in attendance to other specialists was less marked but nevertheless significant (adjusted OR 0.71; 95% CI 0.68-0.75). Once under a doctor's care, patients at most disadvantage were slightly more likely to undergo HbA1c or microalbuminuria estimation (adjusted OR 1.04; 95% CI 1.00-1.10 and adjusted OR 1.22; 95% CI 1.12-1.33, respectively) but were less likely to undergo lipid or HDL cholesterol estimation (adjusted OR 0.81; 95% CI 0.48-0.53 and adjusted OR 0.85; 95% CI 0.79-0.90, respectively). CONCLUSION: While access to medical care is decreased for people at most social disadvantage, once under a doctor's care they receive a level of monitoring that is relatively equal to that provided to people less disadvantaged. IMPLICATION: Strategies are required to ensure equal access to medical services for all persons with diabetes, especially for persons who are at most social and medical disadvantage.