Abstract 17375: Evaluation of a Digital Health Offering to Optimize Blood Pressure and Lipid Control in Patients With Uncontrolled Hypertension and Type 2 Diabetes: A Pilot, Cluster Randomized Study
Introduction: Over half of patients with hypertension (HTN) and type 2 diabetes (T2DM) fail to achieve treatment goals due to medication non-adherence, poor engagement, and therapeutic inertia. This study evaluated the use of Proteus Discover, a digital health offering (DH), consisting of sensor-enabled medicines, a wearable sensor, patient app, and provider portal, to optimize blood pressure (BP) and cholesterol in patients with uncontrolled HTN and DM.
Methods: Subjects with uncontrolled HTN (systolic blood pressure [SBP] ≥140 mm Hg) and T2DM (A1C ≥7%) treated with ≥2 anti-hypertensives plus metformin and/or sulfonylurea were enrolled in this IRB approved 12-Week study. Subjects received DH with sensor-enabled medications for 4 (DH 4-Weeks) or 12 weeks (DH 12-Weeks), or usual care (UC) based on cluster randomization. The primary outcome was change in SBP at Week 4. Other outcomes measured at Weeks 4 and 12 for this analysis are change in BP, proportion of subjects at BP target (<140/90 mm Hg), change in low-density lipoprotein-cholesterol (LDL) in statin-using subjects, medication adherence (DH subjects only), change in Patient Activation Measure (PAM, validated measure of engagement), and medical decisions.
Results: This analysis included 109 subjects (DH [N=80]/UC [N=29] mean age 58/62; female 56%/ 35%). DH subjects had greater BP and LDL reductions compared with UC at Weeks 4 and 12. DH 12-Weeks had greater reductions in SBP and proportion at BP goal at Week 12 than DH 4-Weeks and UC. (Table 1) DH had an overall adherence of 85%. DH had a greater increase in PAM than UC (8±2.4 vs. 2±3.3) and 3 times as many medical decisions than UC subjects, primarily education and lifestyle coaching.
Conclusions: Patients with uncontrolled HTN and T2DM who used DH which supports medication adherence, patient engagement, and treatment optimization achieved greater reductions in BP and LDL, known risk factors for cardiovascular events, and were more likely to achieve the BP goal than UC.
Author Disclosures: J. Frias: Research Grant; Modest; Abbvie, Amgen, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, Novo Nordisk, Pfizer, Sanofi. Consultant/Advisory Board; Modest; Proteus Digital Health, Johnson & Johnson, AstraZeneca, CeQur, Sanofi. N.S. Virdi: Employment; Significant; Proteus Digital Health. P. Raja: Employment; Significant; Proteus Digital Health. Y. Kim: Employment; Significant; Proteus Digital Health. G. Savage: Employment; Significant; Proteus Digital Health. Ownership Interest; Significant; Proteus Digital Health. J. Unger: Research Grant; Modest; Proteus Digital Health, Merck, Novo Nordisk, Janssen Pharmaceuticals, GlaxoSmithKline, Eli Lilly, Sanofi, Takeda Pharmaceutical. Speakers Bureau; Modest; Teva Pharmaceutical, Novo Nordisk, Janssen Pharmaceuticals. Ownership Interest; Modest; Novo Nordisk. Consultant/Advisory Board; Modest; Novo Nordisk, Janssen Pharmaceuticals, Intarcia Therapeutics. Other; Modest; Lippincott. M. Raikhel: Research Grant; Modest; Proteus Digital Health. L. Osterberg: Consultant/Advisory Board; Modest; Proteus Digital Health.
- © 2016 by American Heart Association, Inc.