Category: Diabetes/Prediabetes/Hypoglycemia

Monitor: 30

30 - GLUCOSE VARIABILITY IN TYPE 2 DIABETES WITH U-500R BY PUMP OR INJECTION: VIVID STUDY ADDENDUM

Thursday, Apr 25
1:00 PM – 1:30 PM

Objective :

Continuous glucose monitoring (CGM) devices allow assessment of glycemic variability (GV) and time-in-range (TIR). The VIVID study compared 420 patients with type 2 diabetes (T2D) requiring high-dose insulin (>200 U/day) by 2 methods of Humulin® R U-500 insulin (U-500R) delivery: Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection (MDI). A subset of patients in the VIVID study had CGM monitoring to better understand the impact of these 2 delivery methods on glucose profiles (as measured by GV and TIR).


Methods :

The VIVID study enrolled patients with T2D who had inadequate glycemic control on high-dose non-U-500R (MDI or CSII) or high-dose U-500R (MDI) with or without other insulins/antihyperglycemic agents. CGM using the Dexcom G4 Platinum was performed in patients (27 per arm) from CGM-participating sites. Patients were treated for 26 weeks; CGM data was collected for 3 separate 7-day periods during the wks prior to Wk 0, Wk 14, and Wk 26. Patients and investigators were blinded to CGM results. The primary objective was to compare change from baseline in GV, based on mean daily standard deviation (SD) of glucose measurements between MDI and CSII. Secondary objectives included the Coefficient of Variation (CV) of glucose measurements and % time with blood glucose (BG) ≥70 to ≤180 mg/dL, ≥54 to < 70 mg/dL, < 54 mg/dL, and > 180 mg/dL.


Results :

CGM data from 41 patients with both baseline and postbaseline results were analyzed. At Week 26, the CSII group (n=17) had a significantly greater decrease from baseline compared to the MDI group (n=24) in within-day SD (-8.1 vs ‑0.4 mg/dL, p=0.047) and within-day CV (-2.3% vs 3.1%, p=0.012). % TIR (BG ≥70 to ≤180 mg/dL) increased significantly from baseline with CSII, but not MDI (change from baseline 12.9% vs 3.1%), with no significant difference between groups at study end (% TIR 73.1% vs 63.3%). Changes from baseline in % time < 54 mg/dL, ≥54 to < 70 mg/dL, > 180 mg/dL were not significantly different between groups. Mean glucose decreased in both groups (-18.3 and -15.5 mg/dL).


Discussion :

As reported previously, both methods of U-500R delivery improved glycemic control in high insulin-requiring participants with T2D, with the CSII group having lower HbA1c, fasting plasma glucose, and insulin dose compared to the MDI group. The CGM substudy showed additional clinical benefits of increased TIR and lowered GV with CSII compared to MDI .


Conclusion :

In participants with T2D requiring high dose insulin, U-500R insulin by CSII compared to MDI resulted in increased TIR and lower GV without increasing % time below or above range. CSII could be a viable option for administering U-500R.

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Thomas Blevins

Endocrinologist
Texas Diabetes and Endocrinology
Austin, Texas

Dr. Thomas Blevins attended the University of Texas at Austin as an undergraduate, majoring in Plan II. He attended medical school at the Baylor College of Medicine in Houston and completed his Internal medicine and Endocrinology training there as well.
He has been in Austin since 1986 and was with the Austin Diagnostic Clinic until 2001 when he founded Texas Diabetes and Endocrinology, a practice devoted to bringing the latest in Diabetes advances, Thyroid care and Osteoporosis diagnostics and treatment to Austin and Central Texas.

Wendy Lane

MD
Mountain Diabetes & Endocrine Center
Asheville, North Carolina

Wendy S. Lane, MD graduated magna cum laude from Yale University with degrees in biology and English literature. Dr. Lane has practiced medicine in Asheville, NC since 1998. She is recognized for her expertise in insulin pump therapy and management of insulin resistance. Dr. Lane frequently consults for pharmaceutical and bio-tech companies for designing ethical and practical clinical trials on new diabetes treatments and insulin delivery systems.

Dana K. Sindelar

Principal Clinical Research Scientist
Eli Lilly and Company

Dana Sindelar received his doctorate in Biology/Physiology from Vanderbilt University School of Medicine in 1997. He completed a fellowship in Biology/Physiology at the University of Washington in 2000. He spent 17 years doing preclinical work at Eli Lilly on diabetes and obesity. He transitioned to clinical work on insulin this past year.

Ludi Fan

Research Scientist
Eli Lilly and Company

Ludi Fan is a research scientist in statistics at Eli Lilly and Company. She has been working in diabetes research since 2013 and joined the U-500 development effort in 2017. She has been involved in clinical trials studying insulins, prospective observational studies of real world insulin use, and retrospective cohort studies of treatment patterns, utilization, and costs of anti-hyperglycemic agents. She received her PhD in Biostatistics from the University of Michigan in 2013.

Kelly Ellinor

Consultant in Clinical Trial Project Management
Eli Lilly and Company

Kelly Ellinor received her Bacheolors in Medical Technology from Illinois State University in 1982. She served as Medical Technologist and later Laboratory director for Quest laboratories (Indianapolis) for 14 years. She has been a Clinical Project Manager Consultant for Eli Lilly and Co. for 19 years.

Liza Ilag

Medical Fellow
Eli Lilly and Company

Liza Ilag received her medical degree from University of the Philippines, Manila College of Medicine, May 1992. She completed a Residency in Internal Medicine at the Good Samaritan Hospital/Johns Hopkins University in 1996, and a Fellowship in Endocrinology at the University of Michigan in 2000. She received a Masters in Clinical Research Design and Statistical Analysis from the University of Michigan School of Public Health in 2001. She was a Research Fellow/Lecturer in the Metabolism and Endocrinology Division, University of Michigan, from 2000-2004. She has worked for Eli Lilly and Company in the diabetes business unit since 2004.

Trang Ly

Senior Vice President and Medical Director
Insulet Corporation

Dr. Trang Ly serves as Senior Vice President and Medical Director at Insulet Corporation. Dr. Ly is a leading expert in artificial pancreas and diabetes technologies and leads the Omnipod Horizon™ Automated Glucose Control clinical program. Most recently, she served as Clinical Assistant Professor in the Division of Pediatric Endocrinology at Stanford University School of Medicine. Prior to her time at Stanford, Dr. Ly was a Pediatric Endocrinologist in the Department of Endocrinology and Diabetes at Princess Margaret Hospital for Children in Perth, Australia. Dr. Ly holds a Bachelor of Medicine and Surgery and a PhD in Pediatrics from the University of Western Australia. She is also a fellow of the Royal Australasian College of Physicians, with specialist qualification in Pediatric Endocrinology.

Jennal Johnson

Research Advisor
Eli Lilly and Company

Jennal Johnson is a Research Advisor at Eli Lilly and Company where she has worked since 2011. She is responsible for conducting research and providing medical input into the development of an Integrated Insulin Management system including a mobile medical app and connected insulin pen. She is a certified family nurse practitioner with an MS in Community Health Nursing from Arizona State University (1989) specializing in diabetes and endocrinology with additional certifications in adult diabetes management, diabetes education and diabetes technology. Prior to joining industry, she was in clinical practice as an endocrine nurse practitioner for more than 20 years in Arizona, Virginia and Missouri. She has authored numerous diabetes/endocrine posters and publications and has presented diabetes posters and topics at several national conferences.