Thomas Blevins1, Wendy Lane2, David Rodbard3, Dana Sindelar4, Ludi Fan4, Kelly Ellinor4, Liza Ilag4, Trang Ly5, Jennal Johnson4. 1. Texas Diabetes and Endocrinology, Austin, Texas, USA. 2. Mountain Diabetes and Endocrine Center, Asheville, North Carolina, USA. 3. Biomedical Informatics Consultants LLC, Potomac, Maryland, USA. 4. Eli Lilly and Company, Indianapolis, Indiana, USA. 5. Insulet Corp., Acton, Massachusetts, USA.
Abstract
Background: The EValuating U-500R Infusion Versus Injection in Type 2 Diabetes Mellitus (VIVID) study compared two methods of U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM). Methods:VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for seven consecutive days on each of three occasions: before weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SDw) of CGM glucose. Results: Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [-8.1 mg/dL]) compared with the MDI group (47.0 to 45.8 [-0.4 mg/dL]; P = 0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%, P < 0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoint mean glucose or A1C. Conclusions: In the VIVID CGM substudy of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared with MDI. CSII also significantly increased TIR with no difference between groups.
RCT Entities:
Background: The EValuating U-500R Infusion Versus Injection in Type 2 Diabetes Mellitus (VIVID) study compared two methods of U-500Rinsulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM). Methods: VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for seven consecutive days on each of three occasions: before weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SDw) of CGMglucose. Results: Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [-8.1 mg/dL]) compared with the MDI group (47.0 to 45.8 [-0.4 mg/dL]; P = 0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%, P < 0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoint mean glucose or A1C. Conclusions: In the VIVID CGM substudy of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared with MDI. CSII also significantly increased TIR with no difference between groups.
Authors: Jieling Chen; Sujana Borra; Ahong Huang; Ludi Fan; Roy Daniel Pollom; Robert C Hood Journal: Diabetes Ther Date: 2022-02-21 Impact factor: 2.945
Authors: Grazia Aleppo; Christopher G Parkin; Anders L Carlson; Rodolfo J Galindo; Davida F Kruger; Carol J Levy; Guillermo E Umpierrez; Gregory P Forlenza; Janet B McGill Journal: Diabetes Technol Ther Date: 2021-06-17 Impact factor: 6.118