d-Nav System

by Hygieia  · Based in United States → — AI-driven insulin management for Type 2 diabetes.
Endocrinology Family Medicine Internal Medicine
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Insurance-covered
Regulatory Status Disclosed

Overview

The d-Nav System by Hygieia is an innovative, FDA-cleared AI tool designed to simplify and optimize insulin management for adults with Type 2 diabetes. It integrates a user-friendly mobile application with patented cloud-based technology and virtual clinical support. Patients utilize the d-Nav app to log their glucose readings, receiving real-time, personalized insulin dose recommendations directly to their smartphone. This autonomous titration system, which can connect to any cloud-sharing glucose meter, aims to significantly improve A1C levels and reduce the risk of hypoglycemia, thereby minimizing the need for frequent in-person physician visits. Healthcare providers benefit from a dedicated online portal to monitor patient data, adjust treatment plans, and provide remote oversight. The d-Nav program is supported by clinical evidence demonstrating improved patient outcomes and substantial healthcare cost savings.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Real-time personalized insulin dose recommendations
  • Automated insulin dose titration based on glucose patterns
  • Mobile app for logging glucose readings and receiving doses (iOS and Android)
  • Provider portal for patient data review and treatment plan adjustments
  • Remote clinical support and education
  • Connects to any cloud-sharing glucose meter
  • A1C improvement without increased hypoglycemia risk
  • CPT codes for autonomous insulin dose titration

Use Cases

  • Optimizing insulin dosage for adults with Type 2 diabetes
  • Remote monitoring of diabetes patients by healthcare providers
  • Reducing A1C levels and preventing hyperglycemia
  • Providing patient support between clinic visits
  • Reducing healthcare costs associated with diabetes management

What Physicians Need to Know

Key Capabilities
The d-Nav System, an AI-powered mobile app, provides autonomous, personalized insulin dose recommendations for adults with Type 2 diabetes who inject insulin. It analyzes historical and current glucose levels to adjust insulin prescriptions and supports various insulin regimens. Patients can log glucose readings and view dose history, while safety checks prevent exceeding physician-set thresholds.
Clinical Utility
This system optimizes insulin management, significantly improving A1C levels without increasing hypoglycemia risk. Clinical studies show 90% of patients achieved lower A1C in 90 days, with sustained reductions for over three years. It reduces the need for frequent in-person dose adjustment visits by autonomously providing recommendations and enabling remote monitoring by healthcare professionals.
Integration Options
The d-Nav app is available for iOS and Android devices and can connect to any glucose meter that shares data with the cloud. Physicians access patient data and insulin recommendations through a dedicated provider portal. While it leverages cloud-based infrastructure, direct Electronic Health Record (EHR) system compatibility is not explicitly noted.
Compliance Status
The d-Nav System is FDA-cleared software and is a prescription-only digital therapeutic. It adheres to quality best practices, incorporating patient privacy and security protections.
Pricing Model
The d-Nav service is offered at no cost and with no co-pays to eligible Blue Cross Blue Shield of Michigan (BCBSM) members with Type 2 diabetes in fully insured commercial plans within specific regions.
User Experience
Patients interact with a user-friendly mobile app, entering blood sugar readings before each insulin injection to receive personalized dose recommendations. The process is described as quick, simple, and easy, requiring a smartphone and internet access. Enrollment requires a prescription and a code from their healthcare provider.
Support Quality
The program includes unlimited clinical support from d-Nav Care Specialists who monitor patient data, provide education, and assist with insulin dose adjustments. The company also offers training for both healthcare professionals and patients, along with ongoing technical support via a freephone service.
Implementation Complexity
Implementation involves a prescription from a qualified healthcare provider who sets up the initial insulin treatment plan via a dedicated website. Patients then download the app and use an enrollment code. The system operates on a cloud-based platform, simplifying infrastructure for individual users but requiring initial setup by the provider.
Evidence Base
The d-Nav System is supported by a multi-site randomized controlled trial published in peer-reviewed journals like The Lancet, demonstrating significant A1C reduction without increased hypoglycemia. Clinical studies show long-lasting A1C improvements over three years. It has also been reviewed by NICE.
Physician Tip

For Type 2 diabetes patients on insulin, consider prescribing the d-Nav System to empower them with autonomous, personalized insulin dose adjustments. This can lead to significant A1C improvements and reduced hypoglycemia, minimizing the need for frequent office visits for titration. Leverage the provider portal for remote monitoring of patient data and to adjust treatment plans as needed. The integrated clinical support team can also assist patients, freeing up physician time. Ensure patients understand the need for consistent glucose logging and internet access.

The d-Nav System primarily integrates via its mobile app (iOS/Android) and cloud-based platform, allowing connectivity with various glucose meters that share data to the cloud. A dedicated provider portal facilitates physician access to patient data. However, direct, seamless integration with existing Electronic Health Record (EHR) systems is not widely highlighted, which may require manual data transfer or separate access for comprehensive patient record keeping.

Details

Category Endocrinology & Metabolic AI, Pharmacology & Dosing AI
Pricing Insurance-covered
  • Covered by most commercial insurance carriers, Medicare, and Medicaid in the US
  • A 2022 UK estimate mentioned approximately £100 per person per month (excluding VAT)
DeploymentCloud-based
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The d-Nav System received 510(k) clearance (K181916) from the FDA on February 4, 2019, for its phone app as an aid in optimizing insulin management among people with Type 2 diabetes. It is noted as the first insulin-management phone app capable of titrating individualized doses for all types of insulin regimens.
Integrations
EHR Not specified
Specialties Endocrinology, Family Medicine, Internal Medicine

What the Web Says

The d-Nav System is an FDA-cleared insulin guidance system for adults with type 2 diabetes, designed to help optimize insulin dosing and improve glycemic control. It consists of a smartphone app for patients and a website for healthcare professionals, utilizing proprietary algorithms and a support team to provide personalized insulin dose adjustments. Physicians and experts generally view the system as innovative and effective in automating daily insulin dosage recommendations, which can reduce the burden on healthcare professionals and lead to cost savings.

Overall: Positive

Strengths

  • Automates daily insulin dosage recommendations, reducing the need for frequent clinic visits.
  • Improves glycemic control (HbA1c levels) and reduces diabetic complications.
  • Simple and straightforward for patients to use.
  • Can lead to cost savings by reducing the need for other drugs and complications.
  • Provides continuous patient support through a dedicated team of healthcare professionals.
  • FDA-cleared and recommended by the American Diabetes Association for insulin dosing improvement.

Limitations

  • Some healthcare professionals may need reassurance and training to understand the algorithm-based insulin adjustment.
  • Patient selection is crucial, as users need to understand the technology and dosage guidance.
  • Supporting evidence, particularly long-term comparative studies in the UK, is considered limited.
  • Requires patients to have a smartphone and internet access for the app version.
  • Additional costs may be incurred for staff training and patient education.
  • Some users of the previous physical device expressed concern about patients consistently entering blood glucose readings into the app.

Based on reviews from: vertexaisearch.cloud.google.com, www.ajmc.com, www.nice.org.uk, www.ncbi.nlm.nih.gov, www.dianet.com, www.accessdata.fda.gov, www.digitaltherapeuticsalliance.org, www.researchgate.net, www.texasendocrine.com

Last updated: 2026-07-19

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Press & Coverage

DBusiness Magazine
Hygieia Releases System That Determines How Much Insulin Type 2 Diabetes Patients Need at Time of Injection
Hygieia introduced its FDA-cleared d-Nav insulin management program, which uses AI and patented technology to automatically determine and recommend insulin doses for Type 2 diabetes patients at the time of injection. This system aims to improve glucose management by providing more frequent dose adjustments than traditional physician visits.
2020-04
PR Newswire
Hygieia Announces Publication of Data in The Lancet Demonstrating Superiority of d-Nav Insulin Guidance System Plus HCP Support Over HCP Support Alone for Improving Glycemic Control
Hygieia announced the publication of a multi-site, randomized, controlled clinical study in The Lancet, demonstrating that the d-Nav Insulin Guidance System combined with healthcare professional support provides superior glycemic control for Type 2 diabetes patients compared to HCP support alone. The study showed significant reductions in HbA1c levels for d-Nav users.
2019-02
PMC (The Lancet)
Automated Insulin Dosing Guidance to Optimize Insulin Management in Patients with Type 2 Diabetes; A Multi-Center Randomized-Controlled Trial
This peer-reviewed article provides evidence for the d-Nav system's superiority in optimizing insulin management for Type 2 diabetes patients, showing that automated titration guidance supported by healthcare professionals is more effective than HCP support alone. The d-Nav system streamlines insulin titration in a scalable manner.
2019-03
PR Newswire
Hygieia Receives 510(k) Clearance from FDA for Phone App That Enhances Company's d-Nav Insulin Guidance Service
Hygieia received FDA 510(k) clearance for a phone app that enhances its d-Nav Insulin Guidance Service, making it the first insulin management app to titrate all types of insulin regimens and connect to any cloud-based glucose meter. This expands accessibility and effectiveness for Type 2 diabetes patients.
2019-02
accessdata.fda.gov
d-Nav System. Regulatory letter. FDA.
This regulatory document from the FDA confirms the 510(k) clearance of the d-Nav System on February 4, 2019. It describes the d-Nav System as a software-based, prescription-only product designed to provide insulin dose recommendations for personal insulin management in Type 2 diabetes.
2019-02
PR Newswire
Hygieia Signs Commercial Agreement Making d-Navu00ae Insulin Guidance Service Available to At-Risk Blue Cross Blue Shield of Michigan Members in Southeast Michigan
Hygieia entered a three-year commercial agreement with Blue Cross Blue Shield of Michigan (BCBSM) to cover the d-Nav Insulin Guidance Service for eligible Type 2 diabetes members in Southeast Michigan. This agreement, based on demonstrated cost savings and improved glycemic control, makes the service available at no cost to members.
2018-06
BioSpace
Hygieia adds Metro Detroit Endocrinology Center as clinical partner for its d-Navu00ae Insulin Management Program
Hygieia expanded its d-Nav network by partnering with Metro Detroit Endocrinology Center, making its AI-powered autonomous insulin therapy service available to more patients, including underserved populations. The d-Nav program aims to provide safe and effective insulin treatment by autonomously adjusting doses.
2022-08
JMIR AI
AI-Enabled Personalization of Semaglutide Therapy in Type 2 Diabetes: Systematic Review With an Integration Framework
This systematic review highlights the d-Nav system as an example of reinforcement learning for real-time, adaptive titration of semaglutide dosage in Type 2 diabetes. It suggests that AI-based approaches can outperform standard fixed-dose regimens in various metrics.
2026-03

Videos

Product demos, reviews, and walkthroughs for d-Nav System.

View all on YouTube

Frequently Asked Questions

The d-Nav System utilizes proprietary AI algorithms to autonomously interpret historical and current glucose data, providing personalized insulin dose recommendations directly to patients with type 2 diabetes before each injection. While the system makes autonomous adjustments, a prescription from a qualified healthcare provider is required to initiate the program, and physicians can monitor patient progress and interactions through a secure provider portal.
The d-Nav System is an FDA-cleared Class II Medical Device in the USA, CE-marked Class IIa in the EU, and UKCA marked in the UK. It is also HIPAA-compliant, and the developer, Hygieia, includes safeguards to protect user health information, with data stored in a secure SQL database.
While studies show d-Nav can reduce HbA1c without increasing hypoglycemia, much of the evidence is based on the physical device rather than the app, limiting generalizability for the app version alone. The system is not indicated for patients under 18 years of age or those with gestational diabetes.
The d-Nav System is unique as the only autonomous, FDA-cleared product that automatically interprets data and adjusts insulin prescriptions for all types of insulin regimens, delivering recommendations directly to the patient. While other digital tools, smart pens, and AID systems exist for diabetes management, d-Nav's distinctiveness lies in its level 3 autonomy for insulin dose adjustments in type 2 diabetes.
In the UK, the d-Nav System costs approximately u00a3100 per person per month. In the US, it is covered by Medicare, Medicaid, and most commercial insurance carriers. Studies suggest d-Nav can be cost-saving by reducing HbA1c levels, decreasing the need for other expensive glycemic medications, and potentially lowering costs associated with diabetes complications.
Integrating d-Nav can reduce the burden on primary and secondary care teams by automating daily insulin dosage recommendations, which is often not feasible with current healthcare professional input. However, both patients and healthcare professionals require initial and ongoing training on how to use the device, set up patient apps, and utilize the web-based services for monitoring and dose management.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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