Meeting History - Outcomes Beyond A1C

• 2017 ADA: Reaching an International Consensus on Standardizing CGM
• 2016 FDA Meeting: Public Workshop on Outcomes Beyond A1c Brings Patient Preferences to the FDA – diaTribe.org
• Patient Priorities for Diabetes Drugs: What Does Success Look Like? (Presentation at 2016 FDA Workshop by The diaTribe Foundation and dQ&A)
• 2014 FDA Meeting: FDA-Patient Dialogue on Unmet Needs in Diabetes  – diaTribe.org
• 2012 DIA: Patient Perspective on the Need for Device Oriented Therapy

 

Glucose Metrics / Glycemic Variability

• Bergenstal, R. M. (2015). Glycemic Variability and Diabetes Complications: Does It Matter? Simply Put, There Are Better Glycemic Markers! Diabetes Care, 38(8), 1615-1621. http://care.diabetesjournals.org/content/38/8/1615.long
• Hirsch, I. B. (2015). Glycemic Variability and Diabetes Complications: Does It Matter? Of Course It Does! Diabetes Care, 38(8), 1610-1614. http://care.diabetesjournals.org/content/diacare/38/8/1610.full.pdf
• Kovatchev, B. (March 2017) Metrics for Glycemic Control - From HbA1c to Continuous Glucose Monitoring. Nature Reviews Endocrinology, 13, 425-436. https://www.nature.com/nrendo/journal/v13/n7/full/nrendo.2017.3.html
• Kovatchev B., Cobelli, C., (Apr 2016) Glucose Variability: Timine, Risk Analusis, and Relationship to Hypoglycemia in Diabetes. Diabetes Care, 39(4), 502-510. http://care.diabetesjournals.org/content/39/4/502.long
• Rodbard, D. (Oct 2012) Hypo- and Hyperglycemia in Relation to the Mean, Standard Deviation, Coefficient of Variation, and Nature of the Glucose Distribution. Diabetes Technology and Therapeutics, 14(10), 868-876. https://www.ncbi.nlm.nih.gov/pubmed/22953755

 

Hypoglycemia  

• (2016, November 21), “Glucose Concentrations of Less Than 3.0 mmol/L (54 mg/dL) Should Be Reported in Clinical Trials: A Joint Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes” Diabetes Care, Volume 10, pg. 1-3. http://care.diabetesjournals.org/content/early/2016/11/09/dc16-2215
• Choudhary, P., Rickels, M.R., Senior, P.A., Vantyghem, M.C., Maffi, P., Kay, T.W., Keymeulen, B., Inagaki, N., Saudek, F., Lehmann, R., Hering, B.J. (Jun 2015) Evidence-Informed Clinical Practice Recommendations for Treatment of Type 1 Diabetes Complicated by Problematic Hypoglycemia. Diabetes Care, 38(6), 1016-29. https://www.ncbi.nlm.nih.gov/pubmed/25998294
• Frier, B.M. (Dec 2014) Hypoglycaemia in Diabetes Mellitus: Epidemiology and Clinical Implications. Nature Reviews Endocrinology, 10(12), 711-722. https://www.ncbi.nlm.nih.gov/pubmed/25287289
• Hirsch, I. B. (2013). Reducing Hypoglycemia in Type 1 Diabetes: An Incremental Step Forward. Diabetes Technology & Therapeutics,15(7), 531-532.  https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3709591/pdf/dia.2013.0174.pdf
• Klonoff DC, Alexander Fleming G, Muchmore DB, Frier BM. Hypoglycemia evaluation and reporting in diabetes: Importance for the development of new therapies. Diabetes Metab Res Rev. 2017;33:e2883. https://doi.org/10.1002/dmrr.2883
• Lawton, J., Rankin, D., Elliott, J., Heller, S.R., Rogers, H.A., De Zoysa, N., Amiel, S. (2014) U.K. NIHR DAFNE Study Group. Experiences, views, and support needs of family members of people with hypoglycemia unawareness: interview study. Diabetes Care, 37(1), 109-15. https://www.ncbi.nlm.nih.gov/pubmed/23990515
• Meneilly, G.S. (Feb 2017) Glycemic Targets in the Elderly and Risks of Hypoglycemia. Journal of Diabetes and Its Complications, 31(5), 783-784. http://www.jdcjournal.com/article/S1056-8727(17)30137-X/fulltext
• Munshi, M.N., Slyne, C., Segal, A.R., Saul, N., Lyons, C., Weinger, K. (July 2017) Liberating A1C Goals in Older Adults May Not Protect Against the Risk of Hypoglycemia. Journal of Diabetes and Its Complications, 31(7), 1197-1199. https://www.ncbi.nlm.nih.gov/pubmed/28343792
• Morales, J., Schneider, D., (2014) “Hypoglycemia”, The American Journal of Medicine, Volume 127, pg. 17-24. http://www.amjmed.com/article/S0002-9343(14)00584-1/pdf

 

Future Clinical Trials and Other Research Questions

• (2009, November). “Factors Predictive of Use and of Benefit From Continuous Glucose Monitoring in Type 1 Diabetes” Diabetes Care, Volume 32, Issue 11, pg. 1947-1953. http://care.diabetesjournals.org/content/32/11/1947.full-text.pdf
• Bergenstal, R., Tamborlane, W., Ahmann, A., Buse, J., (2010, July 22), “Effectiveness of Sensor-Augmented Insulin Pump Therapy in Type 1 Diabetes” The New England Journal of Medicine, Volume 363, Issue 4., pg. 311-320. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1002853
• Pickup, J., Freeman, S., Sutton, A., (2011, July 7), “Glycemic Control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data” BMJ, Volume 343. http://www.bmj.com/content/bmj/343/bmj.d3805.full.pdf
• Rodbard, D., (June 2017), "Continuous Glucose Monitoring: A Review of Recent Studies Demonstrating Improved Glycemic Outcomes" Diabetes Technology and Therapeutics, Volume 19, Issue 3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5467105/ 
• Schnell, O., Barnard, K., Bergenstal, R., (2017), “Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting.” Diabetes Technology and Therapeutics, Volume 19, Issue 7, pg. 1-9. http://online.liebertpub.com/doi/10.1089/dia.2017.0054

 

Implementation

• Bailey, T., Grunberger, G., Bode, B., Handelsman, Y., Hirsch, I., Jovanovic, L., Roberts, V.L., Rodbard, D., Tamborlane, W., Walsh, J. (February 2016). “American Association of Clinical Endocrinologists and American College of Endocrinology 2016 Outpatient Glucose Monitoring Consensus Statement.” Endocrine Practice, Vol. 22, No. 2, pp. 231-237. https://www.aace.com/files/position-statements/outpatient-glucose-monitoring-consensus-statement.pdf
• Bergenstal, R. M., Ahmann, A. J., Bailey, T., Beck, R. W., Bissen, J., Buckingham, B., . . . Wesley, D.M. (2013). Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile (AGP). Diabetes Technology & Therapeutics,15(3), 198-211. doi:10.1089/dia.2013.0051. http://online.liebertpub.com/doi/abs/10.1089/dia.2013.0051
• Fonseca, Vivian and Grunberger, George (May 2017). “Letter to the Editor – Standard Glucose Reporting: Follow-Up to the 2016 AACE CGM Consensus Conference.” Endocrine Practice, Vol. 23, No. 5, pp. 629-632. http://journals.aace.com/doi/pdf/10.4158/1934-2403-23.5.629
• Fonseca, V., Grunberger, G., Anhalt, H., Bailey T., Blevins, T., Garg, S, Handelsman, Y., Hirsch, I., Orzeck, E., Roberts, V.L., Tamborlane, W. (August 2016). “Continuous Glucose Monitoring: A Consensus Conference of the American Association of Clinical Endocrinology and American College of Endocrinology.” Endocrine Practice, Vol. 22, No. 8, pp. 1008-1018. http://journals.aace.com/doi/pdf/10.4158/EP161392.CS
• Hirsch, I. B. (2010). Beyond Hemoglobin A1c—Need for Additional Markers of Risk for Diabetic Microvascular Complications. Jama,303(22), 2291. http://jamanetwork.com/journals/jama/article-abstract/186016
• Wright, L. A.-C., & Hirsch, I. B. (2017). Metrics Beyond Hemoglobin A1C in Diabetes Management: Time in Range, Hypoglycemia, and Other Parameters. Diabetes Technology & Therapeutics, 19(Suppl2), S–16–S–26. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5444503/pdf/dia.2017.0029.pdf

 

Additional Notable Articles

• Dubose, S. N., Weinstock, R. S., Beck, R. W., Peters, A. L., Aleppo, G., Bergenstal, R. M., . . . Hirsch, I. B. (2016). Hypoglycemia in Older Adults with Type 1 Diabetes. Diabetes Technology & Therapeutics, 18(12), 765-771. doi:10.1089/dia.2016.0268. http://online.liebertpub.com/doi/abs/10.1089/dia.2016.0268
• Grunberger, G., Bailey, T., Camacho, P., Einhorn, D., Garber, A., Handelsman, Y., Harrell, R.M., Lando, H., Law Jr., B., Leffert, J., Orzeck, E. (May 2015). “Proceedings from The American Association of Clinical Endocrinologists and American College of Endocrinology Consensus Conference on Glucose Monitoring.” Endocrine Practice, Vol. 21, No. 5, pp. 522-532. https://www.aace.com/files/may_ep.pdm.pdf
• Inzucchi S.E., Umpierrez, G., DiGenio, A., Zhou, R., Kovatchev, B. (Nov 2015). How Well Do Glucose Variability Measures Predict Patient Glycaemic Outcomes During Treatment Intensification in Type 2 Diabetes? Diabetes Research and Clinical Practice, 108(1), 179-186. http://www.diabetesresearchclinicalpractice.com/article/S0168-8227(15)00047-9/fulltext
• Kitabchi, A., Miles, J., Umpierrez, G., Fisher, J., (2009, July) Hyperglycemic Crises in Adult Patients with Diabetes. Diabetes Care, Volume 32, Issue 7, pg. 1335-1343. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2699725/pdf/zdc1335.pdf
• Kovatchev, B.P., Breton M.D. (Nov 2015) Hemoglobin A1c and Self-Monitored Average Glucose: Validation of the Dynamical Tracking eA1c Algorithim in Type 1 Diabetes. Journal of Diabetes Science and Technology, 10(2), 330-335. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4773966/
• Kovatchev, B.P. (Nov 2015) Measures of Risk and Glucose Variability in Adults Versus Youths, 17(11), 766-769. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4649723/
• Kovatchev, B.P., Umpierrez, G., DiGenio, A., Zhou, R., Inzucchi, S.E. Sensitivity of Traditional and Risk-Based Glycemic Variability Measures to the Effect of Glucose-Lowering Treatment in Type 2 Diabetes Mellitus. Journal of Diabetes Science and Technology, 9(6), 1227-1235. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4667308/
• Kovatchev, B.P. (August 2017) Hypoglycemia Reduction and Accuracy of Continuous Glucose Monitoring. Diabetes Technology and Therapeutics, 17(8), 530-533. http://online.liebertpub.com/doi/abs/10.1089/dia.2015.0144?journalCode=dia
• McCall, A., Kovatchev, B.P. (Jan 2009) The Median Is Not the Only Message: A Clinican's Perspective on Mathematical Analysis of Glycemic Variability and Modeling in Diabetes Mellitus. Journal of Diabetes Science and Technology, 3(1), 3-11. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2743494/
• Munshi, M.N., Gabbay, R. (June 2017) Glycemic Control and Functionality in Nursing Homes – More Than HbA1c. JAMA Internal Medicine, 177(6), 893-894. http://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2629321
• Pitsillides, A.N., Anderson, S., Kovatchev, B.P. (Jan 2013) Hypoglycemia Risk and Glucose Variability Indices Dervied from Routine Self-Monitoring of Blood Glucose Are Related to Laboratory Measures of Insulin Sensitivity and Epinephrine Counterregulation. Diabetes Technology and Therapeutics, 13(1), 11-17. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3025766/
• Saudek, C., Brick, J. (2009, July 3). “The Clinical Use of Hemoglobin A1c.” Journal of Diabetes Science and Technology, Volume 3, Issue 4, pg. 629-634. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769940/
• Service, F.  (2013) “Glucose Variability” Diabetes Care, Volume 62, Issue 5, pg. 1398-1404. http://diabetes.diabetesjournals.org/content/62/5/1398.full-text.pdf
• Siegelaar, S., Holleman, F., Hoekstra, J., DeVries, J., (2010) “Glucose Variability; Does it Matter?” Oxford Academic endocrine reviews, Volume 31, Issue 2, pg. 171-182. https://academic.oup.com/edrv/article/31/2/171/2354740/Glucose-Variability-Does-It-Matter
• Suh, S., Kim, J. (2015, August). “Glycemic Variability: How do we measure it and why it is important?” Diabetes and Metabolism Journal, Volume 39, Issue 4, pg. 273-282. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4543190/pdf/dmj-39-273.pdf