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The National Diabetes Management Strategy Projects_TNDMS

Magda Catani, Stewart Harris, Susan Webster-Bogaert, Centre for Studies in Family Medicine

Priority Research Areas

EVALUATION OF DIABETES AND CHRONIC DISEASE MODELS OF CARE

Partnerships for Health (P4H)

Principle Investigator: S.B. Harris
Co-Investigators: M. Stewart, J.B. Brown and A. Thind
Funding: Ontario Ministry of Finance/Southwest CCAC

Overview: A comprehensive, mixed-method, evaluation of the Partnerships for Health (PFH) project. The PFH project aimed to enhance diabetes management across the continuum of care by integrating the Chronic Care Model, Model for Improvement and IHI Breakthrough Series approach into educational activities, supportive activities, and reporting activities for primary healthcare teams in Southwestern Ontario. The impact of the project on chronic illness care delivery and diabetes care processes and clinical outcomes was assessed and reported in two publications to date.

Evaluation of the Quality Improvement & Innovation Partnership (QIIP)

Principal Investigators: S.B. Harris, M. Stewart, R. Birtwhistle and M. Green
Co-Investigators: G, Russell, J.B. Brown, A Thind, S Roberts and J Kotecha
Funding: Ontario Ministry of Health and Long-Term Care)

Overview: QIIP, now part of Health Quality Ontario, was instituted to assist with the shift from the traditional reactive model of healthcare delivery to a proactive planned approach through the formation of inter-professional care teams, improvement of community healthcare partnerships, and initiation of quality improvement (QI) programs. One QI initiative, learning collaboratives, focused on diabetes, colorectal screening, and access to care. Investigators from Western and Queen’s performed a comprehensive third-party evaluation of the learning collaborative program using surveys, interviews, chart reviews, and health administrative data. Evaluation results have been reported in two publications to date and more are in progress.m

DIABETES RESEARCH WITH FIRST NATIONS

The Canadian First Nations Diabetes Clinical Management Epidemiologic Study (CIRCLE)

Principle Investigator: S. B. Harris
Co-Investigators: O. Bhattacharyya, B. Zinman and A. Hanley
Funding: Aboriginal Diabetes Initiative, Health Canada

Overview: CIRCLE was a 3-year national research study that partnered with 19 First Nations communities across Canada to document the current state of clinical management of type 2 diabetes and rates of diabetes-related complications and comorbidities in First Nation communities. The CIRCLE study demonstrated that major care gaps exist in the management and treatment of patients with diabetes in First Nations communities. Study results have been presented to First Nation communities and their leaders, and Health Canada policy makers. Four manuscripts have been published; four additional manuscripts are currently in process.

The First Nations Diabetes Surveillance System (FNDSS)

Principle Investigator: S.B. Harris
Co-Investigators: O. Bhattacharyya, A. Thind and A. Hanley
Funding: Aboriginal Diabetes Initiative, Health Canada

Overview: The First Nations Diabetes Sentinel Surveillance System (FNDSS) was developed to address the health gap around limited surveillance and evaluation of diabetes in Indigenous communities in Canada. FNDSS is a web-based system that encompasses community diabetes registries and surveillance of diabetes clinical measures. The system allows users to view their historic clinical indicators and prevalence, enter data, and review and track progress and plan quality improvement initiatives. Patient-level and community-level reports and graphs display health performance as compared to the Canadian Diabetes Association Clinical Practice Guidelines recommendations. Honouring the Ownership, Control, Access and Possession principles and the CIHR Guidelines for Health Research Involving Aboriginal Peoples, communities were involved in all aspects of the process, controlled and owned their data, and had access to their data at all times. FNDSS is currently being utilized as part of the FORGE AHEAD Research Program. A manuscript is currently in process.

Healthy Moms, Healthy Babies (HMHB) – Gestational Diabetes Mellitus

Principal Investigator: S. B. Harris
Co-Investigators: M. Mottola and I. Hramiak
Funding: Juvenile Diabetes Research Foundation (JDRF)

HMHB Website

Overview: First Nations women are at an increased risk of developing both type 2 diabetes and gestational diabetes (diabetes during pregnancy), with rates reported to range from 8-18% and on the rise (higher than the general population). Healthy Moms, Healthy Babies was a program developed to help First Nations women manage the effects of gestational diabetes or type 2 diabetes during pregnancy including a Lifestyle Program with regular physical activity and diabetes education sessions. This study assessed the impact of the Community Lifestyle Program on blood sugar levels and weight gain during pregnancy. Also, a comparison of  blood sugar levels, delivery experience and baby’s health was done between women who wore a continuous glucose monitor and women who used a standard finger-prick glucose meter.
 
Sandy Lake Health and Diabetes Project

Principle Investigator: A. Hanley
Co-Investigators: B. Zinman, S.B. Harris, M. Mamakeesick, J. McKay and T. Wolever
Funding: Canadian Institutes of Health Research (CIHR)

Overview: A multifaceted diabetes prevention program implemented over the past 20 years in the remote fly-in First Nation community of Sandy Lake in northern Ontario. The intervention involved: a school-based diabetes curriculum for children in grades 3 and 4; community activities aimed at increasing awareness and prevention of diabetes including a radio show, walking clubs, grocery store activities, and home visits; and research activities and programs aimed at increasing the understanding of diabetes in the community. The program was developed and monitored through a collaborative partnership between the community and academic researchers. Goals of the Sandy Lake Health and Diabetes Project were to determine the prevalence of diabetes in Sandy Lake, to describe biological and lifestyle factors associated with diabetes, to develop culturally appropriate intervention strategies based on ethnographic data and to provide a model intervention strategy that can be replicated in other First Nations communities. The Sandy Lake Health and Diabetes Project continues to exist in Sandy Lake with the community taking complete ownership of the program and its activities. Many manuscripts about this project are now available in the published domain.

PRAGMATIC STUDIES IN DIABETES CARE

AIM@GP (Advancing INSIGHT Methods in General Practice: Insulin Initiation Support in Primary Care)

Principle Investigator: S.B. Harris
Co-Investigators: H. Gerstein, J.F. Yale. L. Berard
Funding: Aventis Pharma

Overview: The objective of the AIM@GP study was to determine the effectiveness of an insulin initiation strategy to increase family physician insulin prescribing used a stratified, parallel group, randomized controlled design in family physician practices across Canada.

START (Self-Titration with Apidra® to Reach Target)

Principle Investigators: S.B. Harris
Co-Investigators: H. Gerstein, J.F. Yale and L. Berard
Funding: Sanofi
START website

Overview: A randomized controlled trial that determined whether a patient-managed insulin intensification strategy would provide similar glycemic control as a physician-managed strategy. This research was recently published.

INSIGHT

Principle Investigator: H. Gerstein
Co-Investigators: J.F. Yale,  S.B. Harris, and L. Berard
Funding: Sanofi

Overview: A randomized controlled trial comparing the addition of basal insulin to current therapy with a simple self-titration protocol to conventional glycemic management based on avoidance of insulin and intensification of glucose lowering medications by physicians.

CLINICAL AND ADMINISTRATIVE RESEARCH DATABASES

Global Registry and Surveillance System for Diabetes (GRAND)
Principal Investigator: S.B. Harris
Co-Investigator: P. Aschner
Funding: Novo Nordisk Global
GRAND website

Overview: The Global Registry and SurveillANce System for Diabetes (GRAND) Global Registry and Surveillance System for Diabetes (GRAND) is a clinical and epidemiologic surveillance system created to ensure that critical information detailing diabetes in different countries in the world is available. This is essential in light of the fact that there is a general lack of researchable diabetes data at a local, national and international level. GRAND is a centralized, secure and easily accessible web-based surveillance system that registers and tracks individuals with diabetes and their relevant diabetes clinical parameters over time. Both long-term outcome indicators and short-term process indicators can be monitored. This allows for continuous quality improvement evaluation to measure the impact of intervention programs; better monitoring and identification of clinical care gaps; improved understanding of how to inform, evaluate and compare clinical care patterns and identification of innovative quality improvement initiatives.  Building of the success and experience of the First Nations Diabetes Surveillance System, the main goal of the GRAND project was to develop, implement, and coordinate global diabetes registry and surveillance system. The ultimate goal of the GRAND project remains the improvement of diabetes care in different countries across the world. In 2013, GRAND was successfully piloted in London, Canada in two outpatient diabetes referral clinics and an international site in Bogota, Colombia. Two manuscripts are in process.   
 

Web-based Diabetes Record (Web DR)

Principle Investigators: I. Hramiak and S.B.  Harris
Co-Investigators: M. Edmonds, J. Mahon, C. Clarkson and T. Spaic
Funding: Academic Medical Organization of Southwestern Ontario and Division of Endocrinology and Metabolism, St Joseph’s Health Care

Overview: The Web DR project started in 2010 with the purpose of developing a web-based diabetes electronic medical record (EMR) and implementing it in a Primary Care Diabetes Program and Endocrinology diabetes adult clinics at St. Joseph’s Health Care, London, and pediatric outpatient diabetes clinic at London Health Science Center, Children’s Hospital. Two years later, the system was developed and successfully implemented in the above mentioned clinics. At present, 14 physicians and more than 40 aligned health care professionals use Web DR for more than 90 per cent of patient visits. In addition to its clinical use, WebDR was developed to be a comprehensive researchable database. The Web DR researchable database is a de-identified patient demographic and longitudinal clinical information stored in a secure hospital server with direct link to the Web DR system for nightly (24hrs) data update. This database, currently housing demographic and clinical information for more than 16,000 people with diabetes, is now available to researchers based upon Western Research Ethics Board and Web DR Data Committee approval. The researchable database has been utilized for generating ministry reports, quality improvement evaluation processes, identifying patients for clinical trial, and a wide range of research including medical and graduate student researches and dissertations.

INVESTIGATOR INITIATED AND PHARMACEUTICAL SPONSORED CLINICAL TRIALS

FIAsp

Principal Investigator: S.B. Harris
Funding: Novo Nordisk Canada Inc. Pharma Trial [not investigator initiated]

Overview: The FIAsp Study was a 26-week trial comparing the efficacy and safety of meal time FIAsp with meal time insulin aspart and post meal time FIASP, in combination with insulin detemir in a basal-bolus regimen, followed by a 26-week double-blind extension period for the meal time arms. The objective of the FIAsp project was to develop a faster acting insulin formulation. It was expected that the higher early exposure of FIAsp and faster onset of action would provide further clinical benefits in terms of improved prandial glycaemic control, and increased flexibility of dosing than the currently marketed prandial insulin products.

LEADER (Liraglutide Effects and Action in Diabetes:  Evaluation of Cardiovascular Outcome Results)

Principal Investigator: S.B. Harris
Funding: Novo Nordisk Canada Inc.; Pharma Trial [not investigator initiated]

Overview: LEADER Study was a 5 year study evaluating the effect of Liraglutide (Victoza) on the incidence of cardiovascular events. People with diabetes are at a high risk for cardiovascular disease and many of these risk factors can be reduced by modern therapies.  Liraglutide (Victoza), a GLP-1 analogue, has a favourable effect on these risk factors and hence on cardiovascular events. These factors include hyperglycaemia, insulin resistance, dyslipidemia, hypertension, obesity and increased glucagon.

CANOE (Canadian Normoglycemia Outcomes Evaluation)

Principle Investigators: S.B. Harris and B. Zinman
Co-Investigators: H. Gerstein and K. Young
Funding: GlaxoSmithKline

Overview: A double-blind randomized controlled trial was completed in Toronto and London. The study investigated whether low-dose combination therapy would prevent development of type 2 diabetes with three published papers including the major findings published in Lancet.