In this presentation we review the basics of automated diabetes decision support, the methods and components used by decision support algorithms, as well as results from studies testing the feasibility and utility of decision support for patients with diabetes. We conclude that the feasibility of Advisory Systems for diabetes has been demonstrated by recent clinical trials, including pilot studies and larger-scale multi-center investigations using CGM and insulin delivery via insulin pumps or multiple daily injections.
Current decision support systems for insulin dosing in type 1 diabetes fall short to meet the recommended therapeutic targets. In my presentation, I will give a brief overview of the state of the art in decision support for insulin therapy aiming to tackle with the problem of intra-day and inter-day variability. In particular, I will focus on the science, engineering and clinical work currently being done at Imperial College London on bolus-basal insulin decision support using Run-to-Run control and Case-based Reasoning.
Patient-reported outcome measures PROM are a crucial part of outcomes driven medicine; representing the patient perspective in terms of quality of life, psychosocial functioning and successful uptake and continued use of diabetes devices and therapies. Process evaluation of PROMs and their interpretation in outcomes-driven medicine however is less well-understood. Increasingly Payers are demanding PROMs as part of their considerations for reimbursement and regulatory approvals bodies are increasingly examining PROMs as part of their approvals processes. It is important, therefore, that we are able to respond robustly and effectively to ensure people with diabetes continue to receive access to the care they require for optimal biomedical and psychological outcomes.
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The ability to understand and interpret what represents a meaningful difference in PROM across the different measures used is crucial. Outcomes of well-being, psychosocial functioning, quality of life, technology acceptance and functional health status for example and how they link to psychological constructs and behaviour change theory must be transparent.
High quality wearable technologies, applications apps and connected smart phone technologies that focus on exercise tracking and management in diabetes are in critical need. To date, several high-quality apps have been developed by the fitness industry that work seamlessly with wearables i. A few emerging apps and technologies are focusing on physically active customers with diabetes that attempt to integrate diabetes-specific metrics such as continuous glucose monitoring, self-monitoring of blood glucose, food intake and insulin dosing.
Some even provide evidence-informed recommendations on insulin dose titration and carbohydrate snacking to help improve glucose control during planned exercise.
This presentation highlights emerging technologies that help patients living with diabetes engage more safely and more effectively with physical activity. Because adolescents also demonstrate a strong propensity for new technology, one wonders if mHealth apps are well-suited adjuncts to the management of T1DM in this population.
We hypothesized that a tailored approach and inclusion of an adherence mechanism would be needed for an app to be successful. Thus, we interviewed adolescents with type 1 diabetes and their family caregivers and utilized thematic analysis to identify priority design principles. This user-centred approach identified themes such as youths having roles related to data collecting rather than decision making; the need for fast, discrete transactions; and the importance of overcoming decision inertia.
Design of the mobile app included simple, automated transfer of glucometer readings and gamification, whereby routine behaviors and actions are rewarded and encouraged. The app, bant , was first evaluated in a 12 week pilot study. Satisfaction was high and frequency of self monitoring of blood glucose SMBG increased during the short trial. User feedback led to a refined app, which included out-of-range BG trend alerts, coaching around potential causes and fixes of these trends, and a point-based incentive system to support T1DM self-management.
We then conducted a 12 month randomized controlled trial among 92 adolescents. Forty-six youths were enrolled into the treatment arm, and app satisfaction was assessed at 6 and 12 months using a 7-point Likert scale. At trial end, users ordered bant' s 12 features based on perceived usefulness. Linear mixed models showed no changes in primary HbA1c and secondary frequency of hypoglycemia, measures of self-care, quality of life clinical outcomes. However, exploratory analysis demonstrated a significant association between increased SMBG and improved HbA1c in the intervention group.
In summary, bant shows promising ability to engage a subset of adolescents and compliment their current clinical care. Throughout the design and testing of bant , many lessons were learned about the deployment of smartphone apps. Those lessons, along with the results of our clinical trials, will be presented during this session. Education and support initiatives are being developed for closed loop technologies, as hybrid closed loop HCL therapy is now approved in multiple countries.
Research and programmatic development are needed to optimize delivery of education for both clinician and individuals with type 1 diabetes. Clinician education must include both general principles of closed-loop therapy and device specifics. The CARES Calculate, Adjustment, Revert, Education, Sensor paradigm can be useful for distinguishing closed-loop from traditional pump therapy and highlighting clinically meaningful distinctions between devices Table.
Clinicians must also consider their critical role in expectation-setting in order to poise individuals for optimal use of closed loop systems.
Programs should include both initial closed-loop training and ongoing support. Phone follow-ups emphasize carbohydrate ratio adjustments, responding to alerts, and reducing hyperglycemia. Another strategy is to provide targeted education and intervention for specific closed-loop adherence or glycemic challenges. A novel multicenter study of a videoconference-based intervention for families of young children using HCL included focused strategies to address mealtime behaviors, device troubleshooting, exercise and activity, and hypoglycemia mitigation.
Ongoing work is needed to understand beneficial components of closed-loop training programs. Both clinicians and patients require fundamental understanding of the benefits and limitations for closed-loop systems, and systematic ways to optimize their use. Type 1 diabetes T1D management is challenge for both patients and health providers HP. Technology and social media can provide an additional opportunity to support care and improve communication with HP.
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Social media enables support and interaction in the online community. The social media platforms and discussion forums are very popular in young people, which provide unique opportunities for online diabetes education, intervention, and support.
The social media use in healthcare identifies positive effects and outcomes: fosters patient's education, provides psychosocial support; enhances patient's empowerment and reduces illness stigma. Social media has additional unique support, which cannot be offered in regular clinic visits, such as: perspective from the patient's point of view and an almost unlimited amount of time to listen and share experience. Facebook is the largest social media platform and important source of information, support and engagement for patients with chronic diseases.
The communication between T1D patients and HP using Facebook allowed active patient participation in the decision-making process with improved glucose control in patients using insulin pump. Combined use of Facebook and Viber can significantly decrease HbA1c level compared to patients using Facebook only, where patients on insulin pump were more likely to use both social media for T1D management. We believe that in today's challenging healthcare environment of limited budgets and resources with a desire to provide better diabetes care, new methods of patient interaction using social media can be beneficial.
Social media can be additional communication tool between T1D patients and HP and can improve glucose control. The treatment with continuous subcutaneous insulin infusion CSII using insulin pump has been proven to achieve near normoglycemia in type 1 diabetes patients.
In contrast, this therapeutic approach was not implemented to a larger scale in insulin-treated type 2 diabetes T2D , and there is the lack of the data on the requirements for optimal insulin pump therapy in the different metabolic settings of T2D insulin resistance, obesity, dyslipidemia etc. However, the growing number of patients with T2D showing the failure on previous insulin treatment has inspired the studies of the metabolic effects of insulin pump treatment in these individuals. After small-scale inconclusive studies, the OpT2mize trial has convincingly demonstrated an ability of insulin pump treatment to significantly improve HbA1c, but also blood glucose daily variability compared to multiple daily injection insulin therapy.
In addition, the study of the use of insulin pump therapy in newly diagnosed T2D with intensive removal of hyperglycemia resulted in more frequent and longer clinical remission of the disease. The metabolic changes underlying the improvement of blood glucose control remain yet unclarified.
In this context, our studies have demonstrated slower reduction of blood glucose in response to the acute insulin administration with the pump, but significantly better reduction of HbA1c and insulin resistance in the subgroup of highly insulin resistant patients. Our results signify that CSII might be more efficient in patients with higher insulin resistance and that a flexible approach in decreasing blood glucose is a prerequisite for achieving treatment targets. Managing blood glucose levels in people with longstanding type 2 diabetes often requires treatment intensification.
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For people on basal insulin there are now many options, the most crucial step is to recognize the need for additional therapy and engage the patient in shared decision making. The consequences of therapeutic inertia include life shortening and disabling cardiovascular and microvascular complications. Once the decision is made to intensify therapy delays should be minimized.
At each step of treatment intensification, it is important to do a formal reassessment of diet, physical activity, sedentarism and sleep and support the patient in additional strategies for behavior change. The next step is to assess patient characteristics, most importantly the existence of atherosclerotic cardiovascular disease or heart failure.
Other critical patient characteristics that will inform shared decision making are the A1c lowering needed, the need for weight loss or minimizing weight gain, the risk of hypoglycemia, the ability to carry out a complex regimen, renal function, concurrently conditions and cost. Once the strategy has been set the clinic should support the patient for cost-effective access to the medication, instruction to minimize side effects and maximize safety and follow up in 3—6 months to determine efficacy.
If the strategy is either not tolerated or not adhered to a new strategy should be envisioned by the patient and provider. Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like cardiovascular or renal disease. It also places a tremendous financial burden on both patients and health care systems. Glycated hemoglobin A1c HbA1c testing has for decades been considered to be one of the most important laboratory medical advances in diabetes care and plays a key role in the management of diabetes.
HbA1c values represent average glycemic control over the past 2—3 months. They reflect a composition of both pre- and post-prandial blood glucose levels. Regular HbA1c measurement is recommended by international guidelines for all patients with diabetes for the assessment of glycemic control by providing information on long-term glycemic status and reliably predicting a potential risk for diabetes-related complications. One potential disadvantage of traditional HbA1c laboratory testing is that results are not available at the time of the patient visit due to the turn-around time required for testing and reporting.
This delay in communicating results can delay intensification or modification of treatment and reduce patient adherence to the treatment plan. In response to this, HbA1c testing at the point-of-care is currently increasing. The rapid availability of HbA1c results permits the discussion of the results face-to-face, and has the potential to improve patient-doctor dialogue and patient satisfaction, thereby facilitating improved glycemic control.
HbA1c testing at POC was shown to potentially improve diabetes management if undertaken within an adequate comprehensive quality management system. Continued evidence of the accuracy improvements of various POC systems and cost-effectiveness evaluations, together with the implementation of effective quality control measures will support the expansion of these POC testing systems as a key method for HbA1c testing in daily practice.
Continuous glucose data provides a more comprehensive overview about glycemic control e. These new parameters that become accessible to people with diabetes via flash sensor-based glucose monitoring FSGM or continuous glucose monitoring CGM can facilitate treatment and adjustments.