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.

Sensor-Based Technology: Bringing Value to People with Diabetes and the Healthcare System in an Evolving World.

PURPOSE: Evidence demonstrates that glucose-sensing technologies have enabled effective glycemic control for adults and children with type 1 diabetes (T1DM) or adults with type 2 diabetes (T2DM) on insulin therapy or non-insulin therapy. Here, we report on the wider value of glucose-sensing technology from the perspectives of person living with diabetes (PWD), healthcare providers (HCPs), and healthcare policy stakeholders. METHODOLOGY: Literature searches were conducted to identify published records and analysis, including across various healthcare organizations and agencies, of the impact of the FreeStyle Libre® flash glucose monitoring system in diabetes. These findings were combined with the outcomes of three healthcare attitudes surveys among PWD and diabetes healthcare professionals in Canada, including two commissioned for this purpose. RESULTS: Clinical trials data and real-world evidence have proven the benefits of the FreeStyle Libre system on limiting hypoglycemia, lowering HbA1c, optimizing metrics of glucose control and reducing hospital admissions. These benefits are accompanied by improvements in patients' quality of life, work productivity, and savings to the health system. The FreeStyle Libre system has created an opportunity to change the organization and delivery of care, including during COVID-19 restrictions on access to standard care, thus generating system-wide benefits in addition to those accrued by patients and HCPs. CONCLUSION: Evidence-based improvements in glucose control for PWD using flash glucose monitoring are accompanied by increased treatment satisfaction and quality of life. Telemedicine with such remote monitoring systems increases the opportunities for simultaneous review of glucose data with HCPs and shared decision-making, thus encouraging adherence with treatment.

Injection Technique: Development of a Novel Questionnaire and User Guide.

OBJECTIVE: Approximately 200 million people worldwide use injectable therapies as part of diabetes management. There appears to be a significant gap between insulin injection technique recommendations and injection practice for many. We aimed to develop and validate a novel, brief, self-administered injection technique assessment questionnaire. RESEARCH DESIGN AND METHODS: An iterative codesign process was conducted. Focus groups and interviews with adults (or parents of children) with type 1 or type 2 diabetes and health care providers (HCPs) elicited views and refined the tool for broader distribution to the target audience. Questions addressed ease of understanding; relevance; included items and potential missing questions; feelings about diabetes; and any discomfort or judgment felt when completing the tool. A user guide was developed with cognitive interviewing performed to ensure relevance, acceptability, readability, and understanding. Statistical analyses included propensity score matching to identify a subset of the Worldwide Injection Technique Questionnaire with similar characteristics. Boruta feature selection, Cramér's V, and multiple correspondence analysis were conducted. RESULTS: HCPs and 16 people with diabetes participated in the initial focus groups and interviews. Questions were reported as clinically relevant, simple to complete, "about the right length," relevant, and easy to understand. A total of 267 participants completed the survey reviewing the questionnaire. A further 16 participants underwent cognitive interviews. The complete resource was then reviewed by another 23 people with diabetes as a final check for completeness and usability. Statistical analyses demonstrated high validity and reliability. CONCLUSION: This novel resource is clinically relevant, acceptable, and easy to use as both a clinical tool and a self-assessment tool for people using injectable therapies for diabetes.

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.

A Coloured Pen Needle Education System Improves Insulin Site Rotation Habits: Results of a Randomized Study.

INTRODUCTION: Needle reuse and repeated injection of insulin into the same site encourage lipohypertrophy. We explored the potential of coupling a novel pen needle strategy with community pharmacists to improve injection site rotation. METHODS: Between October 2018 and January 2019, adult insulin users with type 1 or 2 diabetes were enrolled by 16 community pharmacists across 7 Canadian provinces and randomized to their usual pen needles (control) or coloured pen needles packaged with education materials in boxes with reminder sound chips (intervention [mCPN]). A total of 203 individuals completed all requirements of the 30-day study. The primary outcome was a composite of the number of zones injected, the use of new injection zones if the number of zones equaled that at baseline, and the change in size of the injection area from baseline. The pharmacists completed two questionnaires, which provided insights into whether study participation elevated their comfort and confidence in providing injection site rotation counselling. RESULTS: Compared to the control group, more participants in the mCPN arm improved their site rotation practices (54.1% vs. 33.7%; P = 0.005), 15 more increased the number of injection zones used (P = 0.03), and there was less needle reuse (25% vs. 12% reduction). The pharmacists reported improved knowledge of the consequences of lipohypertrophy and the proportion who were "very comfortable" with pen needle tip selection and use rose from 31.3% pre-study to 93.8% post-study. CONCLUSION: The coloured pen needles with their education materials are a novel means of encouraging injection site rotation. Community pharmacists represent an untapped resource for improving injection self-care practices.

Understanding the Clinical Profile of Insulin Degludec, the Latest Basal Insulin Approved for Use in Canada: a Narrative Review.

In recent years, the development of basal insulin therapies has focused on insulin analogues that have longer durations of action and more predictable pharmacokinetic/pharmacodynamic (PK/PD) profiles than their human insulin-based predecessors, such as neutral protamine Hagedorn (NPH) insulin. Dosed once-daily, such analogues can provide a more stable glucose-lowering action, which translates clinically into a reduced risk of hypoglycemia. Insulin degludec (degludec) became available in Canada in 2017 and is the first basal insulin analogue to have a half-life exceeding the dosing interval. As well as offering the promise of an exceptionally flat PK/PD profile when at steady state, this characteristic means that insulin degludec can be dosed with some flexibility with regard to time of day and that it need not be taken at the same time each day. However, the approximately 25-h half-life also has some implications concerning dose titration. This article provides an up-to-date review of the study data describing the clinical profile of degludec, and aims to give helpful and practical advice to prescribers about its use. While the clinical benefits of degludec are described, it is also acknowledged that further study is required to better understand how its clinical performance compares with that of insulin glargine 300 units/mL.

Insulin Injection Practices in a Population of Canadians with Diabetes: An Observational Study.

INTRODUCTION: Proper insulin injection technique has demonstrated positive clinical outcomes in patients with diabetes. A Canadian-based practice reflective was undertaken to evaluate the current state of understanding of injection technique practices by patients administering insulin, and the importance physicians place on proper injection technique. METHODS: Twenty-four sites across Canada completed a practice profile survey and enrolled adult non-pregnant patients with either type 1 or type 2 diabetes injecting insulin using an insulin pen. Seven areas of proper injection technique to be evaluated were identified by the study steering committee: size of injection site, use of a skin lift, needle reuse, length of the needle, duration of the needle in the skin, injection into lipohypertrophic tissue, and applied injection force. During a scheduled visit, each patient filled out the Injection Technique Survey and the physician documented the answers via an electronic database. RESULTS: Almost all physicians surveyed agreed (96%) that proper insulin injection technique is important or very important and 80% indicated they were either completely confident or fairly confident in discussing overall insulin injection technique. All patients surveyed were making at least one insulin injection technique error within the following categories: applied injection force (76%), area size of injection site (64%), duration of pen needle in skin (61%), pen needle reuse (39%), performs a skin lift with a 4 or 5 mm needle (38%), uses a longer pen needle than required (34%), and injection of insulin into lipohypertrophic tissue (37%). CONCLUSION: Patients commonly make insulin injection errors. Patient and physician education on optimal insulin injection technique continues to be an unmet medical need for the treatment of patients with diabetes. Prospective trials examining the impact of new technology, diabetes educational teams, and e-learning as educational interventions are potential avenues to explore in future studies to support improved insulin injection technique.

Fixed-Ratio Combination of Insulin and GLP-1 RA in Patients with Longstanding Type 2 Diabetes: A Subanalysis of LixiLan-L.

INTRODUCTION: With longer duration and progression of type 2 diabetes (T2D), ß-cell function deteriorates and insulin therapy often becomes necessary. Glucagon-like peptide-1 receptor agonists such as lixisenatide that do not rely only on ß-cell function and glucagon suppression primarily, but also lower glucose by other (insulin-independent) mechanisms such as delayed gastric emptying, may be appropriate adjuvant therapy to basal insulin in patients with longstanding T2D. METHODS: We assessed the efficacy and safety of insulin glargine (iGlar) versus iGlarLixi, a fixed-ratio combination of iGlar and lixisenatide, stratified by quartiles (Q) of T2D duration (≤ 7.305 [Q1], > 7.305 to ≤ 10.75 [Q2], > 10.75 to ≤ 15.67 [Q3], and > 15.67 years [Q4]) in the LixiLan-L trial (N = 736). RESULTS: Across all quartiles, the reduction in glycated haemoglobin was greater with iGlarLixi versus iGlar, and the difference was most pronounced in patients with the longest duration (Q4; least squares mean difference [standard error] - 0.62 [0.13], P < 0.0001). Additionally, hypoglycaemia rates were significantly lower with iGlarLixi versus iGlar in patients in Q4 (3.3 vs. 6.9 events/patient-year, P < 0.0001). CONCLUSION: iGlarLixi lowered glycated haemoglobin more versus iGlar regardless of T2D duration, with benefit retained even among patients with the longest T2D duration.

The importance of the initial period of basal insulin titration in people with diabetes.

Achieving target glycaemic control is essential in people with diabetes to minimize the risk of long-term complications, and many people with type 2 diabetes will ultimately require basal insulin (BI) therapy to achieve their individualized glycaemic targets. Usually, the first 12 weeks following initiation of BI therapy represents the period when the greatest dose increases and glycaemic reductions occur. Effective glycaemic control combined with minimizing the risk of hypoglycaemia is important to enable the achievement of glycaemic control in the longer term. However, substantial therapeutic inertia exists in clinical practice, both in initiation and up-titration of BI, owing to patient-, physician- and healthcare system-related barriers, including fear of hypoglycaemia and the perception of a burdensome regimen. The more prolonged duration of action, reduced glycaemic variability and lower risk of hypoglycaemia seen with second-generation versus first-generation BI analogues may help alleviate patients' and physicians' concerns and facilitate titration. In turn, optimal BI titration and subsequent metabolic benefits may help improve therapy adherence and self-management. This review details the clinical implications of prompt titration of BI to achieve early glycaemic control, and the importance of minimizing hypoglycaemia risk within the initial titration period. Facilitation of patients' self-management of BI is also addressed.

Insulin Matters: A Practical Approach to Basal Insulin Management in Type 2 Diabetes.

It is currently estimated that 11 million Canadians are living with diabetes or prediabetes. Although hyperglycemia is associated with serious complications, it is well established that improved glycemic control reduces the risk of microvascular complications and can also reduce cardiovascular (CV) complications over the long term. The UKPDS and ADVANCE landmark trials have resulted in diabetes guidelines recommending an A1C target of ≤ 7.0% for most patients or a target of ≤ 6.5% to further reduce the risk of nephropathy and retinopathy in those with type 2 diabetes (T2D), if it can be achieved safely. However, half of the people with T2D in Canada are not achieving these glycemic targets, despite advances in diabetes pharmacological management. There are many contributing factors to account for this poor outcome; however, one of the major factors is the delay in treatment advancement, particularly a resistance to insulin initiation and intensification. To simplify the process of initiating and titrating insulin in T2D patients, a group of Canadian experts reviewed the evidence and best clinical practices with the goal of providing guidance and practical recommendations to the diabetes healthcare community at large. This expert panel included general practitioners (GPs), nurses, nurse practitioners, endocrinologists, dieticians, pharmacists, and a psychologist. This article summarizes the panel recommendations.

Adding prandial GLP-1 receptor agonists to basal insulin: a promising option for type 2 diabetes therapy.

BACKGROUND: Diabetes mellitus is a serious and increasingly prevalent condition in Canada and around the world. Treatment strategies have become increasingly complex, with a widening array of pharmacological agents available for glycemic management in type 2 diabetes mellitus (T2DM). New therapies that act in concert with available basal insulins may represent alternatives to basal insulin intensification with prandial or pre-mixed insulin. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have recently shown promise as useful additions to basal insulin, with significant reductions in glycated hemoglobin and potentially beneficial effects on body weight. This review will focus on pivotal clinical trials to assess the potential benefits of adding prandial GLP-1 RAs to basal insulin in patients with T2DM. METHODS: Clinical studies combining prandial GLP-1 RAs and basal insulin (published between 2011 and July 2017) were identified and reviewed in PubMed, the Cochrane Central Register of Clinical Trials (Issue 6, June 2017), and clinicaltrials.gov. RESULTS: Most of the studies presented in this review show that the addition of a prandial GLP-1 RA to basal insulin results in equal or slightly superior efficacy compared to the addition of prandial insulin, together with weight loss and less hypoglycemia. CONCLUSIONS: The results of the studies suggest that a prandial GLP-1 RA as an add-on to basal insulin may be a safe and effective treatment intensification option (vs basal-plus or basal-bolus insulin).

Insights Into the Current Management of Older Adults With Type 2 Diabetes in the Ontario Primary Care Setting.

OBJECTIVE: The Goal Oriented controL of Diabetes in the Elderly populatioN (GOLDEN) Program assessed the management of older persons with type 2 diabetes in Canadian primary care. METHODS: Data were extracted from the records of 833 consecutively identified persons 65 years of age or older who had type 2 diabetes and were taking 1 antihyperglycemic agent or more; they were managed by 64 physicians from 36 Ontario clinics. RESULTS: More than half (53%) had glycated hemoglobin (A1C) levels of 7.0% or lower, 41% had blood pressure levels below 130/80 mm Hg, and 73% had low-density lipoprotein levels of 2.0 mmol/L or lower; 19% met all 3 criteria. Over the past year, 11% had been assessed for frailty, 16% for cognitive dysfunction and 19% for depression; 88% were referred for eye checkups, and 83% had undergone foot examinations. One-tenth were taking 4 or more antihyperglycemic agents, 87% statins and 52% an angiotensin-converting enzyme inhibitor. More than half of those with high clinical complexity had A1C levels of 7.0% or lower; of these, one-third were taking a sulfonylurea, and one-fifth were taking insulin. In the patients with A1C levels of 7.0% or above and low clinical complexity, there was often no up-titration or initiation of additional antihyperglycemic agents. CONCLUSIONS: Older persons with type 2 diabetes often have multiple comorbidities. Unlike eye and foot examinations, there was less emphasis on evaluating for frailty, cognitive dysfunction and depression. The GOLDEN patients had generally well-controlled glycemic, blood pressure and cholesterol profiles, but whether these would be reflected in a "sicker" population is not known. Personalized strategies are necessary to avoid undertreatment of "healthy" older patients and overtreatment of the frail elderly.

Insights into optimal basal insulin titration in type 2 diabetes: Results of a quantitative survey.

AIMS: Basal insulin (BI) treatment initiation and dose titration in type 2 diabetes (T2DM) are often delayed. Such "clinical inertia" results in poor glycaemic control and high risk of long-term complications. This survey aimed to determine healthcare professional (HCP) and patient attitudes to BI initiation and titration. METHODS: An online survey (July-August 2015) including HCPs and patients with T2DM in the USA, France and Germany. Patients were ≥18 years old and had been on BI for 6 to 36 months, or discontinued BI within the previous 12 months. RESULTS: Participants comprised 386 HCPs and 318 people with T2DM. While >75% of HCPs reported discussing titration at the initiation visit, only 16% to 28% of patients remembered such discussions, many (32%-42%) were unaware of the need to titrate BI, and only 28% to 39% recalled mention of the time needed to reach glycaemic goals. Most HCPs and patients agreed that more effective support tools to assist BI initiation/titration are needed; patients indicated that provision of such tools would increase confidence in self-titration. HCPs identified fear of hypoglycaemia, failure to titrate in the absence of symptoms, and low patient motivation as important titration barriers. In contrast, patients identified weight gain, the perception that titration meant worsening disease, frustration over the time to reach HbA1c goals and fear of hypoglycaemia as major factors. CONCLUSION: A disconnect exists between HCP- and patient-perceived barriers to effective BI titration. To optimize titration, strategies should be targeted to improve HCP-patient communication, and provide support and educational tools.

Considerations for Initiating a Sodium-Glucose Co-Transporter 2 Inhibitor in Adults With Type 2 Diabetes Using Insulin.

In order to meet and maintain glycemic control, pharmacological management of individuals with type 2 diabetes typically begins with metformin followed by the introduction of other oral antihyperglycemic agents as needed. In some patients, the aggressive and progressive degeneration of pancreatic ß cell activity means insulin therapy will become a given. The need to routinely monitor blood glucose levels coupled with the undesirable effects associated with insulin-primarily hypoglycemia and weight gain-commonly contribute to physician and patient inertia. The new ß-cell-independent sodium-glucose co-transporter 2 (SGLT2) inhibitors are approved for combination use with all of the currently approved oral and injectable antihyperglycemic classes. The addition of SGLT2 inhibitors to background insulin therapy has the potential to afford many benefits and, in some cases, may reduce the incidence of insulin-associated side effects. This article reviews the available literature on SGLT2 inhibitor-insulin combination therapy and underscores the issues that should be considered prior to introducing SGLT2 inhibitors to individuals with type 2 diabetes who are already on insulin (with or without other antihyperglycemic agents) to ensure individualization of therapy.

TITRATION: A Randomized Study to Assess 2 Treatment Algorithms with New Insulin Glargine 300 units/mL.

OBJECTIVE: It was uncertain whether an algorithm that involves increasing insulin dosages by 1 unit/day may cause more hypoglycemia with the longer-acting insulin glargine 300 units/mL (GLA-300). The objective of this study was to compare safety and efficacy of 2 titration algorithms, INSIGHT and EDITION, for GLA-300 in people with uncontrolled type 2 diabetes mellitus, mainly in a primary care setting. METHODS: This was a 12-week, open-label, randomized, multicentre pilot study. Participants were randomly assigned to 1 of 2 algorithms: they either increased their dosage by 1 unit/day (INSIGHT, n=108) or the dose was adjusted by the investigator at least once weekly, but no more often than every 3 days (EDITION, n=104). The target fasting self-monitored blood glucose was in the range of 4.4 to 5.6 mmol/L. RESULTS: The percentages of participants reaching the primary endpoint of fasting self-monitored blood glucose ≤5.6 mmol/L without nocturnal hypoglycemia were 19.4% (INSIGHT) and 18.3% (EDITION). At week 12, 26.9% (INSIGHT) and 28.8% (EDITION) of participants achieved a glycated hemoglobin value of ≤7%. No differences in the incidence of hypoglycemia of any category were noted between algorithms. Participants in both arms of the study were much more satisfied with their new treatment as assessed by the Diabetes Treatment Satisfaction Questionnaire. Most health-care professionals (86%) preferred the INSIGHT over the EDITION algorithm. The frequency of adverse events was similar between algorithms. CONCLUSIONS: A patient-driven titration algorithm of 1 unit/day with GLA-300 is effective and comparable to the previously tested EDITION algorithm and is preferred by health-care professionals.