122-LB: iSage: Successful Basal Insulin Titration Managed by a Prescription-Only Digital Therapy for T2DM

Abstract

Ideally, initiating and titrating basal insulin should quickly achieve A1C and fasting glucose targets without significant hypoglycemia. In practice, it’s often not so simple. iSage Rx (iSage) is the first FDA-cleared digital therapy for basal insulin titration that is prescribed by providers and easily downloaded to patients’ mobile phones. In less than a minute, the provider personalizes their patient’s glycemic targets and configures a titration algorithm for use with any basal insulin. The iSage app automatically manages the patient’s titration plan and provides ongoing education regarding insulin administration. We tested the efficacy of iSage in 27 T2DMs (59±7.6 year, 12M/15F). Entry criteria included T2DM patients treated solely with detemir, glargine or delgudec insulin, fluency in English, and generally healthy. T2DMs with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses, severe visual impairment and dementia were excluded. The study aims included changes in both insulin dose and A1C values while achieving low rates of hypoglycemia. The average (SD) starting and app-directed final doses of insulin were 33.6 (20) and 46.8 (27) U/d, p=0.047, respectively. Initial mean A1c was 8.2 (1.4)% that dropped to 7.3 (0.95)%, p=0.002 at study termination (79-139 days). Among those with an initial A1c >8.0, (mean A1c 9.3%) the final mean A1c was 7.4% (1.0) p=0.005. Of the 2,257 fasting blood glucose readings (BG) recorded in the mobile app, only 27 were <70 mg/dL (1.64% of total fasting BGs). Participants required almost no unexpected visits or phone consultations to manage their insulin doses. The iSage digital therapy, while prescribed by a provider, requires minimal provider demands, is patient self-directed, and produces significant reductions in A1C with low rates of hypoglycemia. Disclosure K. Grdinovac: None. D.C. Robbins: None. T.A. Lavenbarg: None. P. Levin: Research Support; Self; MannKind Corporation, Novartis AG, Novo Nordisk Inc. Speaker’s Bureau; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck & Co., Inc., Sanofi. R. Sysko: Employee; Self; iSage Rx, LLC. Funding Amalgam Rx, Inc.; Blue KC