Mountain Diabetes and Endocrine Center

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.

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal

IntroductionPrevious studies have found higher rates of adherence in patients with type 2 diabetes mellitus (T2DM) using insulin pens compared to vial and syringe administration; however, little evidence is available to support this observation in elderly patients.MethodsThis was a retrospective claims database analysis of a predominantly elderly Medicare Advantage with Prescription Drug (MAPD) insurance population consisting of 3172 insulin-naïve patients with T2DM who initiated basal insulin using pre-filled pens or vial and syringe (‘vial’). The index date was defined by the first pharmacy claim for basal insulin. Adherence, measured as proportion of days covered (PDC) and medication possession ratio (MPR), and persistence were evaluated in a 12-month follow-up period using an adjusted days’ supply. Multivariate regression analyses and a Cox proportional hazards model were used to identify characteristics associated with adherence and non-persistence, respectively, and compare findings between the pen and vial groups.ResultsThe pen cohort was slightly younger than the vial cohort (69.4 vs. 70.1 years, respectively; P = 0.0338). Similar proportions of male patients (53.3% vs. 56.8%; P = 0.0529) occurred in both cohorts, and lower Deyo–Charlson Comorbidity Index (4.4 vs. 5.0; P < 0.0001) was found for the pen cohort. Adjusted mean PDC was significantly higher in the pen cohort than the vial cohort (0.67 vs. 0.50; P < 0.001), as was mean MPR (0.75 vs. 0.57; P < 0.0001). Adjusted odds for adherence (PDC ≥ 80%) showed a positive association with use of an insulin pen (odds ratio = 2.19, 95% CI: 1.86–2.59). The adjusted risk of non-persistence (discontinuation) was significantly lower (58%) in the pen cohort relative to the vial cohort (hazard ratio = 0.42, 95% CI: 0.38–0.45). Key limitations include assumptions related to accuracy and comprehensiveness of claims data, and specifically days’ supply data used to measure insulin adherence.ConclusionThese findings suggest that pen devices improved insulin therapy adherence in a primarily elderly MAPD population with T2DM.FundingNovo Nordisk Pharmaceuticals, Inc.Electronic supplementary materialThe online version of this article (doi:10.1007/s12325-015-0266-5) contains supplementary material, which is available to authorized users.