DTx Product Profile

d-Nav®

Product Highlight

Condition targeted:

Type 2 diabetes

How it works:

d-Nav combines an FDA-cleared mobile app enabled by AI technology, and virtual clinical support to make autonomous adjustments to a patient’s insulin prescription based on their historical and current glucose levels.

Impact:

In a clinical study, 90% of patients saw lower A1C levels in 90 days.*

 

* Schneider, J. E., Parikh, A., & Stojanovic, I. (2018). Impact of a Novel Insulin Management Service on Non-insulin Pharmaceutical Expenses. Journal of Health Economics and Outcomes Research, 6(1), 53–62. https://doi.org/10.36469/9783

Product Overview

Medical condition:

Type 2 diabetes

Target patient population:

Patients who inject insulin to manage their type 2 diabetes.

What to expect:

Significant improvement in A1c along with a reduction in the frequency of hypoglycemia when used with outpatient therapy.

 

Note: for more information, please visit https://d-nav.com.

Clinical Overview

Indications for use:

The d-Nav Technology calculates the next dose of insulin to aid in optimizing insulin management. The d-Nav Program is indicated for adults with type 2 diabetes who are injecting insulin.

Outcomes:

In a multi-site randomized control study, d-Nav Technology improved A1C without increasing the risk for hypoglycemia.**

Directions:

The d-Nav Program consists of FDA-cleared software and unlimited clinical support to optimize insulin dosing. Patients use the d-Nav Technology before every insulin injection by entering their most recent sugar reading, and then receiving a personalized dose recommendation. Data is sent to the cloud where it is monitored by d-Nav Care Specialists, who are available to support patients’ good use and address any clinical conditions.

The use of d-Nav is quick, simple, and easy. Clinical studies show long-lasting A1C reduction sustained for over three years.***

Risks & warnings:

d-Nav may not be suitable for patients under 18, or those with gestational diabetes.

Place in therapy:
Complementary to current therapy. Because d-Nav Technology is FDA cleared to autonomously adjust dose recommendations, patients do not need to see their doctor for dose adjustments.

 

** Bergenstal, R. M., Johnson, M., Passi, R., Bhargava, A., Young, N., Kruger, D. F., Bashan, E., Bisgaier, S. G., Isaman, D. J. M., & Hodish, I. (2019). Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial. The Lancet, 393(10176), 1138–1148. https://doi.org/10.1016/s0140-6736(19)30368-x

*** Harper, R., Bashan, E., Bisgaier, S. G., Willis, M., Isaman, D. J., & Hodish, I. (2018a). Temporary Reductions in Insulin Requirements Are Associated with Hypoglycemia in Type 2 Diabetes. Diabetes Technology & Therapeutics, 20(12), 817–824. https://doi.org/10.1089/dia.2018.0266 

Product Access

Product description:

Like the closed loop system for patients using a pump, d-Nav Technology seamlessly takes a glucose reading and calculates the next dose of insulin appropriate for the patient. Then, the patient simply injects the recommended dose. Information regarding a patient’s glucose readings and insulin recommendations are always available to the physician via a dedicated provider portal.  This program improves outcomes and safety of insulin treatment. d-Nav is safe, precise, and highly effective.

Prescription status:

A prescription from a qualified healthcare provider is required.

Patient access:

Patients download the d-Nav app from the Apple or Google App Store. An enrollment code is generated for patients after their healthcare provider completes a prescription with their personalized treatment details. From that point forward, d-Nav Technology will tell the patient what dose to use before every injection. This takes the guesswork out of managing insulin dosing for the patient. Our trained clinical staff will follow up with the patient regularly to reinforce good use and address clinical concerns.

Use of this product requires access to:

Provider access:

A physician’s office will have the ability to track all the interactions the d-Nav team has with any of their patients through a proprietary, secure physician portal. They will have access to simple progress reports, as well as more detailed reports for each of their patients.

Coverage options:

The d-Nav program is covered by Medicare, Medicaid and most commercial insurance carriers.

Product availability:

d-Nav is available in:

A better way to use Insulin.

d-Nav Technology  is the only autonomous, (level 3) FDA-cleared product that automatically interprets data and independently initiates management. d-Nav adjusts an insulin prescription directly to patients, as often as needed.

Clinical Trials

Note: for more research, please visit https://d-nav.com/outcome/.

“d-Nav” refers to the d-Nav Insulin Management Program. “d-Nav Technology” refers to Hygieia’s FDA cleared proprietary mobile app.

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