337-OR: Injection Technique (IT) Training in Subjects Injecting into Lipohypertrophy (LH)—The Tianjin Randomized Controlled Trial (RCT)

Abstract

Rationale: LH is a common local complication of insulin injection. We conducted a 6-month prospective RCT to assess effects of intensive IT training vs. usual care on HbA1c, TDD insulin, LH lesions, injection behavior and BG variability. Methods: Adult subjects injecting into LH lesions were randomized to usual care (N=104), or intensive IT training (N=106): stop LH injections, lower TDD insulin 10-20%, properly rotate injections within and between sites, and reduce needle reuse. The 2 groups saw different study staff to avoid injection practice contamination in Controls. Results: Subjects were well matched for (mean ± SD) insulin injection duration (7.0 ± 5.0 years); HbA1c (8.5 ± 1.1%); TDD insulin (46.2 ± 21.2 IU); LH lesion count (1.9 ± 0.4), strict correct site rotation (2.9%), and factors such as age, BMI, needle reuse (% and frequency), daily number and sites of injections. Subjects did not perform adequate SBGM to assess BG variability. Due to protocol non-adherence (not lowering TDD in initial IT subjects), and injection behavior contamination in 63 Controls, both ITT and Per Protocol (PP) results are shown. Conclusion: Intensive IT training in subjects who inject into LH lesions can safely lower HbA1c even as TDD insulin is reduced. Conduct of LH RCTs with behavioral education is difficult for both investigators and subjects. Control contamination is likely multi-factorial. Disclosure L. Chen: Research Support; Self; Becton, Dickinson and Company. Q. Xing: Research Support; Self; Becton, Dickinson and Company. J. Li: Research Support; Self; Becton, Dickinson and Company. J. Zhou: Research Support; Self; Becton, Dickinson and Company. Y. Yuan: Employee; Self; Becton, Dickinson and Company. H. Xu: Employee; Self; Becton, Dickinson and Company. Y. Wan: Employee; Self; Becton, Dickinson and Company. B.K. Pflug: Employee; Self; Becton, Dickinson and Company. K. Strauss: Employee; Self; Becton, Dickinson and Company. L. Hirsch: Employee; Self; Becton, Dickinson and Company. Stock/Shareholder; Self; Merck & Co., Inc. Funding Becton, Dickinson and Company