HCL and Control-IQ HCL Experience Studies
Insulin pump therapy is a well-recognized method for treating patients with diabetes. Unlike treatment regimens that employ multiple daily insulin injections and a depot of long-acting insulin to address background insulin needs (basal insulin), insulin pumps deliver small amounts of rapid acting insulin continuously into the subcutaneous tissue through an insulin pump site.
As the technology surrounding diabetes treatment has improved remarkably over the last few decades, the number of options for diabetes management have also increased. For many, these advances in care have shown improvements in health outcomes (e.g. increased time in target range, decreased HbA1c, etc.) as well as in one’s quality of life (e.g. routine flexibility). However, this phase of rapid innovation in diabetes care can be difficult for some as re-adjustment of daily lifestyle routines may be necessary. Hybrid (also known as partial) closed-loop therapy is one innovation driving a shift in diabetes care towards automated care. In the current literature, there are some studies examining glycemic control and the psychological impact of hybrid closed loop over short periods of time (e.g. several days to several weeks). However, data regarding the transition period from usual pump therapy to hybrid closed loop in a realistic, community setting is lacking. It is the clinical experience of the study investigators that patient with type 1 diabetes using insulin pump therapy experience a period of adjustment as they adopt and integrate new technology such as a novel pump start, a pump upgrade to a newer model, or integration of continuous glucose monitoring (CGM) sensors with pump therapy. Learning to navigate and building trust in their new pump technology remains to be a significant challenge for many.
The aim of this study is to assess and characterize the patient experience during their adjustment period with HCL systems (including Control-IQ HCL). In the long term, we aim to develop clinical practice guidelines for physicians working with patients transitioning into HCL systems. The results of this survey study will generate novel data that will allow physicians to better understand the issues faced by individuals transitioning from standard insulin pump therapy into hybrid closed-loop pump therapy. Insights generated from this data can be used to establish guidelines that will help physicians address potential patient challenges with HCL as well as ensure a smooth transition process.
Virtual Care Study
Effective management of diabetes is an ongoing and evolving challenge for health care professionals. Fluctuations of glucose levels over the lifetime of patients with diabetes can lead to complications such as nephropathy, neuropathy, retinopathy and cardiovascular diseases. Management through medications such as oral agents and insulin help patients maintain blood glucose levels at normal or in the range of acceptable levels. However, for those requiring more intensive management, another challenge is the dissemination of adequate care for patients in underserved areas where there is a lack of diabetes specialists.
Self-monitoring of blood glucose (SMBG) is an adjunct used alongside interventions to help verify the efficacy or modify a given treatment to achieve proper control. The practical value of SMBG for the patient can be limited if clinical visits, and therefore feedback on readings, are scarce. Previous studies have shown that frequent communication of SMBG with an endocrinologist can lower A1C by a statistically significant amount. Further studies have shown that this effect is lost without continual communication, is similar to a continuous blood glucose monitor, and is feasible for a large patient population over a long period.
Developing a system of care based on such remote interventions may be a feasible and cost-effective way to provide medical care for diabetes in underserved populations lacking diabetes specialists. In this study, we wish to perform a prospective interventional study to determine whether a virtual-care based system can help reduce HbA1c in patients with diabetes. We propose that a virtual diabetes centre, hosted on the web, combined with virtual endocrinologist consultations and ongoing diabetes feedback can be used to effectively manage patients such that they will demonstrate improved clinical outcomes. Data from this study will be used to provide evidence for integration of virtual-care based systems in healthcare.
COVID-19 & Patient Satisfaction
Effective management of diabetes is an ongoing and evolving challenge for healthcare professionals. The COVID-19 pandemic has drastically altered healthcare delivery and patient care in unprecedented ways and has been a stressful and emotionally taxing time for diabetes patients. The literature suggests that the telemedicine consultations that have replaced in-person appointments during the pandemic may be an effective diabetes management strategy with high patient satisfaction. Additionally, some clinicians have found cloud-based diabetes management devices and telephone consultations during the COVID-19 pandemic to be a suitable alternative to traditional in-person appointments. However, it remains unclear how patient satisfaction has been affected by the complex lifestyle and healthcare delivery changes caused by the COVID-19 pandemic. The aim of this study is to evaluate and characterize the effects of the COVID-19 pandemic on patient satisfaction in patients with type 1 and type 2 diabetes mellitus.