Digitally Enhanced Insulin Therapy—A Multicenter Clinical Trial
Authors: HODISH ISRAEL , BERGENSTAL RICHARD M. , JOHNSON MARY L. , PASSI REBECCA A. , BHARGAVA ANUJ , YOUNG NATALIE , KRUGER DAVIDA F. , HAILEY ANGELA , UNGER EMILY , BASHAN ERAN 
Published: June 2018

A quarter of patients with type 2 diabetes (T2D) use insulin, yet most remain under treated. The shortcoming of the therapy stems from its dynamic nature which necessitate frequent dosage titration. In reality, current overburdened health-care systems fall short of time to delivering sufficient insulin titrations. The d-Nav® Insulin Guidance Service overcomes this barrier. d-Nav is a handheld device that automatically titrates insulin dosage at least weekly, based on glucose readings that the patient is already scheduled to take with the d-Nav. Additionally, the service includes dedicated support of care specialists. We enrolled 181 sub-optimally controlled T2D patients to a multicenter, 1:1 randomized control trial to assess the effectiveness and safety of the d-Nav service compared to close follow-up of diabetes specialists. Both groups received 7 interactions in the 6-month study.
d-Nav group: automatic titrations occurred 1±0.2 times per week (see Figure.); A1c reduction 8.7±0.8% to 7.7±1.0%; 94.6% retention; high-level of satisfaction and comfort; minor hypoglycemia (&lt;55mg/dl) 0.3±0.6/month.
Control: A1c reduction 8.5±0.8% to 8.2±0.9% (p&lt;0.0001 between groups).
Severe hypoglycemia: statistically similar and low. Expansion of supervised automated insulin titrations is feasible as long as it is simple to use by the patient and it does not increase providers’ burden. It may lead to a sizable reduction in complications and costs.

Disclosure
I. Hodish: Stock/Shareholder; Self; Hygieia. R.M. Bergenstal: Research Support; Self; Johnson & Johnson Services, Inc.. Consultant; Self; Johnson & Johnson Services, Inc.. Research Support; Self; Abbott. Advisory Panel; Self; Abbott. Research Support; Self; Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Takeda Pharmaceuticals U.S.A., Inc., Dexcom, Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Research Support; Self; Eli Lilly and Company, Sanofi. Advisory Panel; Self; Sanofi, Roche Pharma. Research Support; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Hygieia. Advisory Panel; Self; Hygieia, Glooko, Inc.. Research Support; Self; JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases. M.L. Johnson: Research Support; Self; Calibra Medical, Medtronic, Sanofi, Novo Nordisk Inc., Abbott, POPS! Diabetes Care, National Institute of Diabetes and Digestive and Kidney Diseases, Dexcom, Inc., Hygieia, JDRF. R.A. Passi: Research Support; Self; Novo Nordisk Inc., Bristol-Myers Squibb Company, Hygieia, Amylin Pharmaceuticals, Medtronic, Calibra Medical, JAEB Center For Health Research, Boehringer Ingelheim Pharmaceuticals, Inc., National Institutes of Health, JDRF, Abbott, POPS Diabetes Care, Dexcom, Inc.. A. Bhargava: None. N. Young: None. D.F. Kruger: Research Support; Self; Dexcom, Inc.. Speaker's Bureau; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc.. Consultant; Self; Intarcia Therapeutics, Inc., Abbott. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Research Support; Self; JAEB Center For Health Research. Consultant; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Consultant; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca. Research Support; Self; Hygieia, Lexicon Pharmaceuticals, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Speaker's Bureau; Self; Valeritas, Inc., Insulet Corporation. Consultant; Self; Insulet Corporation. Research Support; Self; Insulet Corporation. Consultant; Self; Merck & Co., Inc.. A. Hailey: None. E. Unger: Employee; Self; Hygieia. E. Bashan: Employee; Self; Hygieia.