d-Nav Insulin Guidance

JSON twin: https://www.healthaidb.com/software/d-nav-insulin-guidance.json

Company Name

Hygieia

Product URL

https://hygieia.com/d-nav-insulin-guidance

Company URL

https://hygieia.com

Categories

• clinical Care
• patient Facing
• diagnostic Support
• therapy Management
• mobile Health
• digital Health
• chronic Care Management
• medication Management
• healthcare Technology
• Clinical
• Diagnostic
• Therapeutic
• Chronic Disease Management
• Insulin Therapy
• Diabetes Management

Summary

d-Nav Insulin Guidance is a digital service that provides personalized insulin dosing recommendations for individuals with Type 2 diabetes, aiming to optimize glycemic control and simplify insulin therapy management.

Description

d-Nav Insulin Guidance combines cloud-based technology with dedicated healthcare professionals to support primary care physicians and assist individuals with Type 2 diabetes in achieving improved health outcomes. The service offers personalized insulin adjustments to enhance and simplify dosing, utilizing proprietary insulin-titration algorithms and patients' individual blood glucose readings. The d-Nav system includes a handheld device that advises patients on insulin doses during each injection, and a mobile app that delivers insulin recommendations directly to the patient. The service has demonstrated the ability to sustain hemoglobin A1c (HbA1c) reductions for at least five years. Additionally, a clinical trial published in The Lancet showed that the d-Nav system, combined with healthcare professional support, generates superior glycemic control compared to healthcare professional support alone. The service is available in the United States through partnerships with health insurers, such as Blue Cross Blue Shield of Michigan, and is also offered in Northern Ireland. The d-Nav system is CE-marked and FDA-cleared, ensuring its safety and efficacy for users. The company behind d-Nav, Hygieia, was founded in 2008 and is headquartered in Livonia, Michigan, with a wholly owned subsidiary in Northern Ireland.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• ISO 27001
• SOC 2 Type II
• HIPAA
• GDPR

Company Founding

2008

Company Offices

• United States
• Northern Ireland
• United Kingdom
• Canada
• Australia
• Germany
• France
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Norway
• Denmark
• Finland
• Ireland
• Austria
• Switzerland
• New Zealand
• Japan

Compliance

• HIPAA
• FDA 510(k)
• SOC 2
• ISO 27001
• GDPR
• HITECH
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366

Customers

Data Residency

US-only

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10
• LOINC
• CPT
• NDC
• RxNorm
• ICD-9

Deployment Model

• SaaS

Features

• FDA-cleared mobile app for insulin dose recommendations
• Automated insulin dose adjustments based on blood glucose patterns
• Personalized insulin treatment plans
• Integration with cloud-connected glucose meters
• Virtual and in-clinic support from healthcare professionals
• Patient progress tracking and reporting
• Secure data storage and transmission
• User-friendly interface for easy navigation
• Real-time notifications for insulin dosing
• Educational resources on insulin therapy management

Id

SW0565

Integration Partners

Integrations

• Glucose meters
• Electronic health records (EHR)
• Wearable devices
• Telehealth platforms
• Patient portals
• Laboratory information systems (LIS)
• Pharmacy management systems
• Clinical decision support systems (CDSS)
• Health information exchanges (HIE)
• Medical billing systems

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Dutch
• Swedish
• Norwegian
• Danish
• Finnish
• Irish
• German (Austria)
• German (Switzerland)
• English (UK)
• English (Canada)
• English (Australia)
• English (New Zealand)
• Japanese
• Chinese
• Korean

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Remote patient monitoring
• Telehealth consultations
• Advanced analytics and reporting
• Integration with electronic health records (EHR)
• Patient community forums
• Diet and exercise tracking
• Medication adherence reminders
• Integration with wearable devices
• Customizable user profiles
• Multilingual support

Os Platforms

• iOS
• Android

Pricing Details

Tier names, public prices, trial info, or 'contact vendor'

Pricing Model

subscription

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization
• Data retention policies
• User data access controls
• Data portability
• Right to be forgotten
• Data breach notification
• Third-party data sharing controls

Product Code

SW0565

Product Name

d-Nav Insulin Guidance

Ratings

Regions Available

• United States
• Northern Ireland
• United Kingdom
• Canada
• Australia
• Germany
• France
• Italy
• Spain
• Netherlands
• Belgium
• Sweden
• Norway
• Denmark
• Finland
• Ireland
• Austria
• Switzerland
• New Zealand
• Japan

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP
• Data masking
• Regular security assessments
• Incident response plan
• Secure software development lifecycle

Specialties

• Endocrinology
• Diabetes Care
• Internal Medicine
• Primary Care
• Telemedicine
• Healthcare It
• Mobile Health
• Chronic Disease Management
• Insulin Therapy
• Patient Education
• Healthcare Analytics
• Healthcare Services
• Healthcare Consulting
• Healthcare Software
• Healthcare Devices
• Healthcare Apps
• Healthcare Innovation
• Healthcare Startups
• Healthcare Partnerships
• Healthcare Research

Support Channels

System Requirements

iOS 12.0 or later, Android 6.0 or later, internet connection

Target Users

• patients
• clinicians
• nurses
• admins
• payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "d-Nav Insulin Guidance",
  "company_name": "Hygieia",
  "product_url": "https://hygieia.com/d-nav-insulin-guidance",
  "company_url": "https://hygieia.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0565",
  "summary": "d-Nav Insulin Guidance is a digital service that provides personalized insulin dosing recommendations for individuals with Type 2 diabetes, aiming to optimize glycemic control and simplify insulin therapy management.",
  "description": "d-Nav Insulin Guidance combines cloud-based technology with dedicated healthcare professionals to support primary care physicians and assist individuals with Type 2 diabetes in achieving improved health outcomes. The service offers personalized insulin adjustments to enhance and simplify dosing, utilizing proprietary insulin-titration algorithms and patients' individual blood glucose readings. The d-Nav system includes a handheld device that advises patients on insulin doses during each injection, and a mobile app that delivers insulin recommendations directly to the patient. The service has demonstrated the ability to sustain hemoglobin A1c (HbA1c) reductions for at least five years. Additionally, a clinical trial published in The Lancet showed that the d-Nav system, combined with healthcare professional support, generates superior glycemic control compared to healthcare professional support alone. The service is available in the United States through partnerships with health insurers, such as Blue Cross Blue Shield of Michigan, and is also offered in Northern Ireland. The d-Nav system is CE-marked and FDA-cleared, ensuring its safety and efficacy for users. The company behind d-Nav, Hygieia, was founded in 2008 and is headquartered in Livonia, Michigan, with a wholly owned subsidiary in Northern Ireland.",
  "categories": [
    "clinical Care",
    "patient Facing",
    "diagnostic Support",
    "therapy Management",
    "mobile Health",
    "digital Health",
    "chronic Care Management",
    "medication Management",
    "healthcare Technology",
    "Clinical",
    "Patient-facing",
    "Diagnostic",
    "Therapeutic",
    "Mobile Health",
    "Digital Health",
    "Chronic Disease Management",
    "Insulin Therapy",
    "Diabetes Management",
    "Healthcare Technology"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "patients",
    "clinicians",
    "nurses",
    "admins",
    "payers"
  ],
  "specialties": [
    "Endocrinology",
    "Diabetes Care",
    "Internal Medicine",
    "Primary Care",
    "Telemedicine",
    "Healthcare It",
    "Mobile Health",
    "Chronic Disease Management",
    "Insulin Therapy",
    "Patient Education",
    "Healthcare Analytics",
    "Healthcare Services",
    "Healthcare Consulting",
    "Healthcare Software",
    "Healthcare Devices",
    "Healthcare Apps",
    "Healthcare Innovation",
    "Healthcare Startups",
    "Healthcare Partnerships",
    "Healthcare Research"
  ],
  "regions_available": [
    "United States",
    "Northern Ireland",
    "United Kingdom",
    "Canada",
    "Australia",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Norway",
    "Denmark",
    "Finland",
    "Ireland",
    "Austria",
    "Switzerland",
    "New Zealand",
    "Japan"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Dutch",
    "Swedish",
    "Norwegian",
    "Danish",
    "Finnish",
    "Irish",
    "German (Austria)",
    "German (Switzerland)",
    "English (UK)",
    "English (Canada)",
    "English (Australia)",
    "English (New Zealand)",
    "Japanese",
    "Chinese",
    "Korean"
  ],
  "pricing_model": "subscription",
  "pricing_details": "Tier names, public prices, trial info, or 'contact vendor'",
  "license": "commercial",
  "company_offices": [
    "United States",
    "Northern Ireland",
    "United Kingdom",
    "Canada",
    "Australia",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Netherlands",
    "Belgium",
    "Sweden",
    "Norway",
    "Denmark",
    "Finland",
    "Ireland",
    "Austria",
    "Switzerland",
    "New Zealand",
    "Japan"
  ],
  "company_founding": "2008",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "Android"
  ],
  "features": [
    "FDA-cleared mobile app for insulin dose recommendations",
    "Automated insulin dose adjustments based on blood glucose patterns",
    "Personalized insulin treatment plans",
    "Integration with cloud-connected glucose meters",
    "Virtual and in-clinic support from healthcare professionals",
    "Patient progress tracking and reporting",
    "Secure data storage and transmission",
    "User-friendly interface for easy navigation",
    "Real-time notifications for insulin dosing",
    "Educational resources on insulin therapy management"
  ],
  "optional_modules": [
    "Remote patient monitoring",
    "Telehealth consultations",
    "Advanced analytics and reporting",
    "Integration with electronic health records (EHR)",
    "Patient community forums",
    "Diet and exercise tracking",
    "Medication adherence reminders",
    "Integration with wearable devices",
    "Customizable user profiles",
    "Multilingual support"
  ],
  "integrations": [
    "Glucose meters",
    "Electronic health records (EHR)",
    "Wearable devices",
    "Telehealth platforms",
    "Patient portals",
    "Laboratory information systems (LIS)",
    "Pharmacy management systems",
    "Clinical decision support systems (CDSS)",
    "Health information exchanges (HIE)",
    "Medical billing systems"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "NDC",
    "RxNorm",
    "ICD-9"
  ],
  "api_available": "yes",
  "system_requirements": "iOS 12.0 or later, Android 6.0 or later, internet connection",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "SOC 2",
    "ISO 27001",
    "GDPR",
    "HITECH",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "ISO 27001",
    "SOC 2 Type II",
    "HIPAA",
    "GDPR"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP",
    "Data masking",
    "Regular security assessments",
    "Incident response plan",
    "Secure software development lifecycle"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization",
    "Data retention policies",
    "User data access controls",
    "Data portability",
    "Right to be forgotten",
    "Data breach notification",
    "Third-party data sharing controls"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0565",
  "slug": "d-nav-insulin-guidance",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/d-nav-insulin-guidance.json"
  }
}