Comparing Two Telehealth Interventions for Patients with Clinic-Refractory Type 2 Diabetes: A Randomized Controlled Trial

Patients whose type 2 diabetes (T2D) remains persistently poorly-controlled despite receiving clinic-based care are at high risk for complications and costs. To address clinic-refractory T2D within the Veterans Health Administration, we conducted a randomized trial comparing two nurse-delivered telehealth strategies to augment clinic-based care: 1) telemonitoring and care coordination; and 2) a comprehensive intervention combining telemonitoring, self-management support, diet/activity support, medication management, and depression management. Delivery of both interventions utilized only existing clinical staff and infrastructure. Patients (n=200) with HbA1c continually ≥8.5% for ≥1 year despite receiving diabetes management from Primary Care and/or Endocrinology were randomized in a 1:1 ratio to the two 12-month intervention arms between 12/2018 and 1/2020. We analyzed our primary outcome, HbA1c collected at 0, 3, 6, 9 and 12 months, using linear mixed models. Secondary outcomes included BMI and hypoglycemia. Patients had a mean age of 58, and were mostly male (78%) and African American (72%); all patients were engaged with Primary Care prior to enrollment, and 68% with Endocrinology. Baseline characteristics were similar across arms. Estimated mean baseline HbA1c was 10.08%, which declined to an estimated 9.23% at 12 months in the telemonitoring arm and 8.67% in the comprehensive telehealth arm (estimated between-arm difference at 12 months -0.55%, 95%CI -1.06%,-0.05%, p=0.03). No difference in BMI between arms was seen. Hypoglycemia rates were low, and similar between arms. While both strategies improved HbA1c in this high-risk, clinic-refractory population, the comprehensive telehealth intervention led to a clinically and statistically significant added HbA1c benefit. Because its delivery relies solely on existing clinical resources, this comprehensive intervention may be a practical means to address clinic-refractory T2D. Disclosure M. J. Crowley: None. D. H. Jeter: None. E. Strawbridge: None. T. C. Wilmot: None. G. A. Tisdale: None. T. Marcano: None. D. L. Overby: None. M. A. Durkee: None. S. Bullard: None. M. Dar: None. A. Mundy: None. P. E. Tarkington: Stock/Shareholder; Self; Bristol-Myers Squibb Company, Eli Lilly and Company, Johnson & Johnson. S. T. Szabo: None. S. Desai: None. E. A. Kobe: None. N. Majette elliott: None. D. Edelman: None. H. B. Bosworth: Board Member; Self; Preventric Diagnostics, LLC., Consultant; Self; Novartis Pharmaceuticals Corporation, VIDYA, Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Improved Patient Outcomes, Novo Nordisk, Otsuka America Pharmaceutical, Inc., Sanofi. M. L. Maciejewski: Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Spouse/Partner; Amgen Inc. K. Steinhauser: None. A. S. Jeffreys: None. C. Coffman: None. V. Smith: None. S. Danus: None. Funding U.S. Department of Veterans Affairs (IIR 16-213); Durham Veterans Affairs Center of Innovation to Accelerate Discovery and Practice Transformation (CIN 13-410)