Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange
| Autor: | Alicia H. McAuliffe-Fogarty, Dana Ball, Gina Agiostratidou, Stuart A. Weinzimer, Evgenia Gourgari, Kent Reifschneider, Paul Madden, Henry Anhalt, Aaron J. Kowalski, Anne Peters, Karen N. Harriman, Molly McElwee-Malloy, Karen Rubin, Sripriya Raman, Lawrence Blonde |
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| Rok vydání: | 2017 |
| Předmět: |
medicine.medical_specialty
endocrine system diseases Diabetic ketoacidosis Endocrinology Diabetes and Metabolism MEDLINE Continuous Glucose Monitoring and Risk of Hypoglycemia 030209 endocrinology & metabolism Type 2 diabetes Hypoglycemia Diabetic Ketoacidosis 03 medical and health sciences Endocrinology 0302 clinical medicine Diabetes mellitus Internal medicine Outcome Assessment Health Care Internal Medicine medicine Humans 030212 general & internal medicine Societies Medical Glycated Hemoglobin Advanced and Specialized Nursing Type 1 diabetes business.industry Stakeholder nutritional and metabolic diseases medicine.disease United States Diabetes Mellitus Type 1 Endocrinologists Hemoglobin A Diabetes Mellitus Type 2 Hyperglycemia Family medicine business |
| Zdroj: | Diabetes Care |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc17-1624 |
| Popis: | OBJECTIVE To identify and define clinically meaningful type 1 diabetes outcomes beyond hemoglobin A1c (HbA1c) based upon a review of the evidence, consensus from clinical experts, and input from researchers, people with type 1 diabetes, and industry. Priority outcomes include hypoglycemia, hyperglycemia, time in range, diabetic ketoacidosis (DKA), and patient-reported outcomes (PROs). While priority outcomes for type 1 and type 2 diabetes may overlap, type 1 diabetes was the focus of this work. RESEARCH AND METHODS A Steering Committee—comprising representatives from the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange—was the decision-making body for the Type 1 Diabetes Outcomes Program. Their work was informed by input from researchers, industry, and people with diabetes through Advisory Committees representing each stakeholder group. Stakeholder surveys were used to identify priority outcomes. The outcomes prioritized in the surveys were hypoglycemia, hyperglycemia, time in range, DKA, and PROs. To develop consensus on the definitions of these outcomes, the Steering Committee relied on published evidence, their clinical expertise, and feedback from the Advisory Committees. RESULTS The Steering Committee developed definitions for hypoglycemia, hyperglycemia, time in range, and DKA in type 1 diabetes. The definitions reflect their assessment of the outcome’s short- and long-term clinical impact on people with type 1 diabetes. Knowledge gaps to be addressed by future research were identified. The Steering Committee discussed PROs and concluded that further type 1 diabetes–specific development is needed. CONCLUSIONS The Steering Committee recommends use of the defined clinically meaningful outcomes beyond HbA1c in the research, development, and evaluation of type 1 diabetes therapies. |
| Databáze: | OpenAIRE |
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