Role of Academia In Achieving Targets in Diabetes Care

Transcription

1 Role of Academia In Achieving Targets in Diabetes Care

2 Disclosures Member of NovoNordisk, Lilly, Metavention, Sanofi, and Janssen Diabetes Advisory Boards

3 Role of Academia in Discovering New Treatments Recognize and enunciate the issue that needs to be addressed in order to improve the care of people with diabetes Conflicting hypotheses: Does hyperglycemia cause diabetes complications or is it merely associated with diabetes complications?

4 Role of Academia in Discovering New Treatments Provide critical insights regarding the physiologic and pathologic processes that are relevant to the hypothesis to be tested In vitro and in vivo studies determining how glucose metabolism is regulated in the absence of diabetes In vitro and in vivo studies determining how diabetes alters the regulation of glucose metabolism Models establishing plausible mechanisms by which hyperglycemia could cause diabetic complications toxicity (e.g. aldose reductase pathway; glycosylation; vascular dysfunction)

5 Role of Academia in Providing Evidence For and Against New Treatments Provide the scientific underpinning for studies directed at prevention or reversal of the problem Molecular insights regarding pathogenesis of diabetic complications Methods to quantify diabetic retinopathy, neuropathy, and nephropathy in humans Epidemiologic studies that established the incidence, prevalence and natural history of diabetic complications in order to facilitate the design and enable power calculations for intervention studies

6 Role of Academia in Discovering New Treatments Perform experiments that determine the cause of the abnormality to be treated Glucose production is increased in people with type 1 diabetes who have fasting hyperglycemia Adequate basal insulin is required to regulate glucose production during the night and in between meals Adequate and appropriately timed increments and subsequent decrements in insulin are needed to normalize postprandial glucose concentrations Correction doses of insulin or carbohydrate are required to treat glucose concentrations that are either above or below goal

7 Role of Academia in Discovering New Treatments Develop a treatment that safely can correct the targeted abnormality Subcutaneous insulin infusion Multiple daily insulin injections Ultralente or NPH plus pre-prandial regular insulin Basal and pre-prandial analogues Self glucose monitoring Glycosylated hemoglobin

8 Role of Academia in Providing Evidence For and Against New Treatments Design and conduct trials of the proposed therapy The KROC study demonstrated the feasibility of using MDI or a subcutaneous insulin infusion to achieve differing glycosylated hemoglobin concentrations in subjects randomized to intensive or standard therapy The DCCT, a large, randomized, multiyear trial, conducted by early adaptor academic centers established the benefit of intensive therapy. Development, validation, implementation of new measurements and treatment approaches required to successfully execute the DCCT as well as the creation of novel and sophisticated methods of data collection and analysis

9 Role of Academia in Providing Evidence For and Against New Treatments Lead ongoing assessment of outcomes and the communication of the results of a pivotal trial Conducted systematic and unbiased long term follow-up studies that determined the risk versus the benefit of the new therapy Facilitated national and international dissemination of results of the DCCT and EDIC via presentations and publications Created tutorials and oversaw in the clinic training of health care providers around the world on how to implement what rapidly became the standard of care for people with type 1 diabetes and many people with type 2 diabetes

10 Role of Academia in Establishing Treatment Guidelines Lead the development of strategies to mitigate risks and maximize benefits of a new therapy Defined the mechanisms of glucose counter regulation in humans Described the syndrome of hypoglycemic unawareness Created animal models that aided in the determination of the cause(s) of hypoglycemic unawareness Developed practical approaches to minimize the risk of hypoglycemia in humans Introduced the use of pancreas transplantation and islet transplantation as a viable option for people who suffered from debilitating hypoglycemia Lead efforts to develop a viable closed loop insulin infusion system

11 Role of Academia in Establishing Treatment Guidelines Develop consensus and establish guidelines regarding the goals of the new treatments Led and served on the ADA committee that established the standard of care for people with diabetes as a HbA1c of less than 7% in the absence of hypoglycemia or other co-morbid conditions that limit life expectancy Led and served on AACE, Endocrine Society, EASD, IDF etc committees that established similar guidelines Led and served on the panel that created the criteria for the ADA provider recognition program that subsequently served as the basis for guidelines developed by national oversight bodies (e.g. HEDIS, CMS, etc) Conducted and authored evidence based meta-analyses of the outcomes of the new therapy (e.g. Cochrane)

12 Role of Academia in Coordination of Care Create effective systems for delivery and evaluation of a new treatment Pioneered the concept of team based delivery of care Developed the health informatics systems necessary to assess patterns of care and patient outcomes Introduced the use of telecommunication to deliver care Developed methods to enhance patient education, patient empowerment and patient choice

13 Role of Academia as Advocates for the Patient Ensure the patient is at the center of health care delivery Advocated at the state and national levels for coverage of the essential components of the new treatment (e.g. self glucose monitoring, insulin pens, insulin pumps) Provided the impetus and information that enabled self care in schools and prisons Worked to prevent and remove discrimination towards people who have diabetes Ensured that insurance coverage is available for patients who need either pancreas or islet transplantation

14 Role of Academia in Achieving Targets in Diabetes Care Recognize and enunciate the issue that needs to be addressed in order to improve the care of people who either have diabetes or are at (high) risk of getting diabetes Provide critical insight regarding the physiologic and pathologic processes that are relevant to the hypothesis to be tested Provide the scientific underpinning for the prevention or reversal of the problem

15 Role of Academia in Achieving Targets in Diabetes Care Perform the experiments that lead to an understanding of the cause of the abnormality to be treated Develop a treatment that safely can correct the targeted abnormality Design and conduct pivotal trials of the proposed new therapy Lead ongoing assessment of outcomes and the communication of the results of pivotal trials

16 Role of Academia in Achieving Targets in Diabetes Care Lead the development of strategies to mitigate risks and maximize benefits of the new therapy Develop consensus and establish guidelines regarding the goals of the new therapy Create effective systems for delivery and evaluation of the new therapy Ensure the patient is at the center of health care delivery