The National Diabetes Management Strategy Projects_TNDMS

Diabetes Evaluation Framework for Innovations in National Evaluations (DEFINE)

Principal Investigator: S.B. Harris
Funding: Sanofi-Aventis
DEFINE website

Overview: The overall aim of DEFINE is to guide the comprehensive evaluation of diabetes prevention and management, and to facilitate policy innovations in order to improve diabetes care and reduce the clinical and financial burden of diabetes. Comprehensive evaluations can help us move beyond system performance to 1) explore the relationship between investments/programs and outcomes, 2) more accurately measure the impact of investments, and 3) enable policy makers, government, and other stakeholders to make informed decisions. DEFINE can help build the knowledge and evidence needed to improve the Canadian healthcare system. The DEFINE Package includes: a Five Step Evaluation Framework, a Determinants of Health Schematic (schematic of the relationships between medical and non-medical determinants of health), an All-inclusive Multi-level Indicator Set to facilitate the selection of multi-level indicators related to specific evaluation question(s) (a complete menu of indicators), a Table of Associated Measurement Tools, and a Priority Multi-level Indicator Set to emphasize critical indicators that should be part of most comprehensive evaluations. The need for and the development of the framework have been reported in two publications to date. Two additional manuscripts demonstrating the applicability of the framework are currently in process.

Evaluation of the Diabetes Guide On The Side Program Using DEFINE

Principal Investigator: S.B. Harris
Co-Investigators: A. Mikalachki and J. Paquette-Warren
Funding: Sanofi-Aventis Canada

Overview: The Diabetes Evaluation Framework for Innovation National Evaluations (DEFINE) was developed to encourage comprehensive evaluation of diabetes strategies, programs and initiatives in order to better understand the mechanisms underlying optimal diabetes care and to inform healthcare decision makers about the state of their healthcare system. The main purpose of this study is to make use of DEFINE to guide the evaluation of the Outreach Program: Diabetes ‘Guide on the Side’ and capture details about the use and applicability of DEFINE. This evaluation study has two parts: Part A focuses on obtaining details about the program implementation process, the use of the various components of the DEFINE package and resources, and the perceptions of the evaluation team regarding the use and applicability of DEFINE in facilitating the evaluation of the Outreach Program; Part B - will investigate the impact of the Outreach Program on clinical measures as well as assess changes in the capacity of clinicians and patients to manage diabetes. This will be accomplished by gaining insight into the various components of the program and getting feedback from clinicians and patients who participated in the Outreach Program in relation to its implementation and perceived impact on their capacity to manage diabetes. Finally, clinical information will be studied to draw inferences and determine causality between the Outreach Program and changes in clinical measures.

Transformation of Indigenous Primary Healthcare Delivery (FORGE AHEAD)

Principal Investigator: S.B. Harris
Co-Investigators: E. Barre, O. Bhattacharyya, D. Dannenbaum, K. Dawson, R. Dyck, J-A. Episkenew, M. Green, A. Hanley, B. Lavallee, A. Macaulay, A. McComber, H. McDonald, M. Parry, S. Reichert, J. Salsberg, A. Thind, S. Tobe, E. Toth, A. Walsh, J. Wortman, L. Wylie and M. Zwarenstein.
Funding: Canadian Institutes of Health Research, The Lawson Foundation, AstraZeneca Canada Inc.
FORGE AHEAD website

Overview: The overarching goal of FORGE AHEAD is to develop and evaluate community-driven, culturally relevant, primary healthcare models that enhance chronic disease management and appropriate access to available services in First Nations communities in Canada. FORGE AHEAD incorporates a series of program activities designed to foster community-driven initiatives with type 2 diabetes mellitus as the action disease. FORGE AHEAD is founded in participatory action research principles that simultaneously ensure culturally appropriate implementation and integrate knowledge translation by involving community partners throughout the entire program. The strong multidisciplinary and cross-jurisdictional research team across 9 provinces includes First Nations community representatives, Indigenous and non-Indigenous healthcare providers, clinician scientists, academic researchers reflecting a wide variety of disciplines from across Canada, the Assembly of First Nations (AFN), the First Nations and Inuit Health Branch (FNIHB) of Health Canada, the Canadian Diabetes Association (CDA), and the Heart & Stroke Foundation. FORGE AHEAD will produce a tool-kit of tested strategies that can be successfully implemented, sustained and used in First Nations communities across Canada to improve chronic disease care. The outcomes of this research program, its related cost and the subsequent policy recommendations, will have the potential to significantly affect future policy decisions pertaining to chronic disease care in First Nations communities. Manuscripts are currently in process.

Alliance for Healthy Hearts & Minds (CVCD)

Principal Investigators: S. Anand, M. Friedrich and J. Tu
Co-Investigators: S.B. Harris, C. Lai, A. Hanley, S. Bruce, E. Toth, L. Arbour and N. Caron
Funding: Canadian Partnership Against Cancer (CPAC) and Heart and Stroke Foundation of Canada (HSFC)

Overview: Cardiac, vascular, and cognitive dysfunction have a strong impact on a person’s quality of life, longevity and healthcare costs, in Canada and globally. It is of paramount importance to understand the early determinants of such dysfunction and its progression to clinical events especially in Aboriginal peoples who are at high risk for chronic diseases including cancer and cardiovascular disease (CVD). The CVCD Alliance aims to determine the causes of heart disease, stroke, cancer, and other chronic diseases and their risk factors, and also factors influencing overall health and disease among Canadians. Approximately 10,000 participants from across Canada will be invited to participate in this program to: 1) understand the role of socio-environmental and contextual factors (such as societal structure, activity, nutrition, social and tobacco environments, and access to health services) on CV risk factors, subclinical disease, and clinical CV events at the individual and population levels. This will include investigating the impact of contextual factors on geographic variation in CVD (i.e. rural vs urban, and east to west gradient), and their relative impact compared to individual level factors; 2) characterize the unique patterns of contextual factors (as defined above) as well as acculturation, cultural continuity, and migration experience as related to individual CV risk factors, health service utilization (i.e. screening, access to diagnostics and treatments), and clinical outcomes among high risk ethnic groups including South Asians, Chinese, African origin, and reserve-based Aboriginal people from across Canada; and 3) identify early subclinical dysfunction in the brain, vessels and the heart using magnetic resonance imaging, and to investigate the associations with contextual and individual determinants of this dysfunction, as well as to assess the predictive value of novel markers of subclinical dysfunction on the development of clinical CV events.

InHYPO-DM

Principal Investigator: S.B. Harris
Co-Investigators: J.B. Brown and S. Reichert
Funding: Sanofi

Overview: Some pharmacological therapy used to manage diabetes can increase a patient’s risk of hypoglycemia. Hypoglycemia is the most common diabetes-related adverse event, and so the aim of this study is to develop a survey that will explores Canadians’ clinical and personal perspectives and practices related to hypoglycemia and its impact on the management of diabetes. The survey will be founded on the Theoretical Domains Framework (TDF) developed by Cane et al. (2012), the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) and a comprehensive knowledge translation (KT) approach and will be administered to people with diabetes, their family members, and care providers. The study will be implemented in two phases. The purpose of Phase 1 is to gain knowledge from the literature and key stakeholder groups about how hypoglycemia impacts diabetes management that will in turn inform the design and content of the survey. The purpose of Phase 2 is to capture new information about the impact of hypoglycemia on diabetes management by first piloting the survey and then implementing it nationwide. This methodological approach to survey development ensures the comprehensiveness and appropriateness of the survey tool.  This study is the first of its kind in the Canadian context.

Patient and Care Provider Perceptions and Experience Using a Decision Aid Tool for Self-Monitoring of Blood Glucose

Principal Investigator: S.B. Harris
Co-Investigators: A. Mikalachki
Funding: Abbott Laboratories

Overview: Diabetes self-management includes self-monitoring of blood glucose (SMBG) readings, taking medication, exercise, dietary management, and foot care. Evidence suggests that SMBG alone may be of limited clinical effectiveness. This may be because patients are unable to interpret results and make adjustments to their care plan. By providing patients with the tools needed to review, interpret data, and receive feedback, a blood glucose meter with built-in algorithms could facilitate and improve the acceptance of SMBG. Putting the limited use of titration algorithms in the context of escalating diabetes prevalence rates, strategies and tools are urgently needed to help both patients and primary care providers efficiently initiate and continue basal insulin therapy. Basel insulin is considered to be the appropriate strategy after oral diabetic agent failure. This project could set the stage for the need for a blood glucose meter with built-in algorithms designed to support decision making by patients as well as care providers. The project will evaluate the uptake and use of the newly developed blood-glucose meter (FreeStyle Precision Neo meter), and its impact on primary care diabetes consultation. FreeStyle Precision Neo has a built-in basal insulin dose calculator developed by Abbott Diabetes Care.

Data Gaps & Cost Evaluation in Diabetes Care

Principal Investigator: S.B. Harris
Co-investigators: N. Mittmann and T. Spaic
Funding: Novo Nordisk Canada

Overview: The overall aim of this project is to utilize a cohort of individuals with diabetes who received care from diabetes outpatient referral clinics in London, Ontario, and other resource utilization data sources to assess and measure costs of diabetes and its complications. The cohort will be derived from an EMR-based researchable database currently in use in those clinics. The objective of the project will be fulfilled through a stepwise process that includes identifying cost related variables captured in the cohort dataset, identifying potential resource utilization data sources, linking the cohort data to cost related information obtained from another source(s) to allow economic evaluation, and assessing and analyzing the potential relationships between glycemic levels, diabetes-related hospitalizations, and hospital costs among adult patients. A manuscript presenting the impact of prescription drug coverage on diabetes outcome is in progress.

DUAL VI

Principal Investigator: S.B. Harris
Funding: Novo Nordisk Canada Inc., Pharma Trial

Overview: Type 2 diabetes (T2DM) is a progressive disorder characterized by insulin resistance, progressively impaired insulin secretion, increased hepatic glucose output as well as diminished incretin effect leading to chronic hyperglycaemia. IDegLira (consisting of insulin degludec and liraglutide) is a combination product under clinical development for treatment of type 2 diabetes. DUAL VI is a 32-week trial confirming the efficacy and safety of IDegLira in insulin-naïve subjects with T2DM inadequately controlled on metformin alone (or in combination with pioglitazone – U.S. only) using two different titration algorithms (once weekly and twice weekly). The purpose of the DUAL VI trial is to test whether an alternative, simplified (once weekly instead of twice weekly) titration algorithm is similarly effective and safe in patients previously treated with 1-2 oral antidiabetic drugs (OADs). If the tested hypothesis is confirmed, this trial will serve to form a basis of evidence-driven simplified treatment guidance with the combination product IDegLira in management of T2DM, both for prescribers and the patients.

DECLARE (Dapagliflozin Effect on CardiovascuLAR Events)

Principal Investigator: S.B. Harris
Funding: AstraXeneca, Pharma Trial

Overview: DECLARE is a 5 year study evaluating whether treatment with dapagliflozin (10 mg once daily) reduces major adverse cardiovascular events in patients with type 2 diabetes (T2DM) and with either known cardiovascular disease or at least two risk factors for cardiovascular disease (e.g., age, hyperlipidemia, hypertension, recent smoking history-primary prevention). The primary objective of the DECLARE Study is to determine whether treatment with dapagliflozin when added to current therapy will result in a reduction in the incidence of cardiovascular death, myocardial infarction (MI), or ischemic stroke. Researchers will collect and store deoxyribonucleic acid (DNA) for future exploratory research into genes/genetic variation that may influence response (e.g., distribution, safety, tolerability and efficacy) to treatment with dapagliflozin or other drugs and genetic factors that may influence susceptibility to T2DM and/or associated cardiovascular conditions and their risk factors. 

RESET-IT

Principal Investigator: R. Retnakaran
Co-Investigators: H. Gerstein, S.B. Harris, C. Thorpe, N. Yakubovich and B. Zinman
Funding: Canadian Institutes of Health Research (CIHR)

Overview: The central problem in type 2 diabetes (T2DM) is an inability of the beta-cells of the pancreas to produce enough insulin for the body's needs. This "beta-cell dysfunction" worsens over time. No current diabetes medications are known to stop this worsening beta-cell dysfunction; therefore, over time patients need permanent insulin therapy. Recent work suggests that early in the course of T2DM, short-term treatment with intensive insulin therapy (IIT) can temporarily improve beta-cell function. RESET-IT aims to test a new approach. Participants with recently-diagnosed T2DM will be treated with a short course of IIT for 3 weeks and then receive either (i) intermittent IIT for 2 week every 3 months or (ii) continuous treatment with metformin (the standard first-line medication for the treatment of diabetes). This study will determine whether the initial improvement in beta-cell function achieved with short-term IIT can be better preserved after 2 years with intermittent IIT as compared to ongoing metformin therapy. If it shows that this novel treatment strategy can indeed preserve beta-cell function, then this study will open the door to a new approach to the clinical management of T2DM that may offer promise for addressing the clinical and public health challenge posed by the diabetes epidemic.

PROMISE (PROspective Metabolism and ISlet cell Evaluation formerly called epi-CANOE)

Principal Investigators: S.B. Harris, A. Hanley, B. Perkins and B. Zinman
Funding: Canadian Institutes of Health Research (CIHR), Canadian Diabetes Association, Heart and Stroke Investigator Trial

Overview: Obesity and its associated metabolic consequences, including insulin resistance and type 2 diabetes (T2DM) are public health problems of increasing importance in Canada.  The growing burden of diabetes is of particular concern given the seriousness of the chronic complications of the disease, which include retinopathy, neuropathy, nephropathy and cardiovascular disease. As the population ages and the diabetes burden increases, the inevitable wave of diabetes-related morbidity will pose major challenges for families, communities and the health care system. Although progress has been made in identifying risk factors for obesity and diabetes, the spectrum of the disease process from obesity though diabetes is complex, and relatively little information is available regarding risk factors for and progression through important intermediate stages such as insulin resistance, beta cell dysfunction, impaired fasting glucose and impaired glucose tolerance.  Identifying factors related to movement through these stages is important because strategies for intervention can be identified and implemented prior to the onset of diabetes and associated complications. PROMISE is a 15 year observational (no study medication) study of approximately 800-1000 individuals age 30 and older (18 and older for Aboriginal subjects) at high risk for glucose intolerance. After the 15 year study period, there will be long term follow up through record linkage to the Canadian Institute of Health Information and the Statistics Canada vital statistics databases, both of which are standard methods for determining whether hospitalizations or deaths have occurred among participants. The overall objective of the PROMISE study is to understand the determinants of obesity, impaired fasting glucose, impaired glucose tolerance, T2DM and associated metabolic abnormalities, including insulin resistance, beta cell dysfunction and microalbuminuria.