iSage Rx (by Amalgam Rx)
Overview
iSage Rx by Amalgam Rx, Inc. is a prescription-only mobile application designed to assist adult patients with Type 2 diabetes and their healthcare providers in managing basal insulin titration.
The tool is intended for use in non-acute care settings and is specifically for patients with Type 2 diabetes who do not use mealtime insulin or an insulin pump.
iSage Rx integrates into a clinical workflow by allowing physicians to select from various clinically validated basal insulin algorithms, which can then be tailored to individual patient needs. Patients use the app to input their fasting blood glucose levels, and the app provides recommended basal insulin doses according to the prescribed titration plan. Healthcare providers can monitor patient progress, including starting doses and blood sugar levels, through a provider portal.
Notable capabilities include its FDA 510(k) clearance in the United States, and CE Mark in Europe, for automated titration of all major brands of basal insulin. The app also offers behavioral, clinical, and educational support for patients, such as supportive messages, video content on insulin administration, and information on what to expect during insulin therapy. iSage Rx has the capability to titrate basal insulin and medications that combine basal insulin and GLP-1 receptor agonists. It can connect with Bluetooth-enabled blood glucose meters for data collection.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated basal insulin titration for Type 2 diabetes
- Clinically validated algorithms adaptable by physicians
- Behavioral, clinical, and educational support for patients
- Reminders for fasting blood glucose checks
- Remote data monitoring by healthcare providers
- Compatibility with major basal insulins (Lantus, Levemir, Toujeo, Tresiba, Basaglar)
- Connectivity to Bluetooth-enabled blood glucose meters (Roche, Lifescan, Ascensia)
- EHR integration for streamlined workflow and data return
- Personalized dose recommendations based on daily fasting blood glucose
- Supportive messages and video content for insulin administration
Use Cases
- Automating basal insulin titration for Type 2 diabetes patients
- Supporting patient self-management of insulin therapy
- Enhancing glucose control in Type 2 diabetes patients
- Providing educational and behavioral support for insulin users
- Streamlining insulin dose optimization for healthcare providers
- Integrating digital health solutions into EHR workflows
What Physicians Need to Know
iSage Rx can significantly streamline basal insulin titration for your Type 2 diabetes patients, reducing the need for frequent office visits for dose adjustments. Customize titration algorithms based on patient-specific needs (e.g., weight, hypoglycemia risk). Leverage the remote monitoring capabilities to keep track of patient progress and adherence. Encourage patients to utilize the in-app educational resources for better self-management. Consider its potential for integration with your EHR to further optimize workflow and data management.
Amalgam Rx is actively working on expanding integrations beyond Bluetooth-enabled glucometers to include CGM and smart insulin pens. Their 'titration engine' is designed for integration into various diabetes operating systems and EHRs (Athena, Epic, Cerner, Allscripts), aiming to provide a seamless flow of patient data and decision support directly within existing clinical workflows. This focus on interoperability suggests a future where insulin titration is a readily available service within broader digital health ecosystems.
Details
| Category | Endocrinology & Metabolic AI, Patient Engagement & Education, Pharmacology & Dosing AI |
| Pricing | Not available publicly; pursues insurance coverage model. — Not a direct-to-consumer model; aims for insurance coverage with a potential copay for users. |
| Deployment | Mobile app (prescription-only), integrated with EHR systems. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated iSage Rx is the first FDA-cleared mobile app for the automated titration of all brands of basal insulin for adults with Type 2 diabetes, aged 21 and older. It received its 510(k) clearance in 2017. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Family Medicine, Internal Medicine |
What the Web Says
iSage Rx by Amalgam Rx is an FDA-cleared, prescription-only mobile application designed to help patients with Type 2 diabetes manage their basal insulin dosage. It automates insulin titration based on clinically validated algorithms and provides educational and behavioral support. The app aims to simplify dose management and improve adherence to treatment plans, allowing physicians to monitor progress remotely.
Overall: PositiveStrengths
- FDA-cleared for automated basal insulin titration in Type 2 diabetes.
- Compatible with all major basal insulins.
- Allows physicians to choose and tailor clinically validated algorithms for individual patients.
- Provides behavioral, clinical, and educational support for patients.
- Enables remote monitoring of patient's blood sugar levels and adherence by healthcare providers.
- Simplifies dose management and helps patients reach target blood sugar ranges.
Limitations
- Requires a prescription and activation code to use.
- Not intended for patients with Type 1 diabetes, gestational diabetes, or those using an insulin pump.
- No direct-to-consumer pricing information available; relies on insurance coverage.
- Not a replacement for professional medical care and management.
- Limited public reviews from physicians, healthcare IT, or tech reviewers outside of initial launch announcements and company demonstrations.
Based on reviews from: Digital health player Amalgam Rx launches with Type 2 diabetes app - Guided Solutions, iSage Rx - App Store - Apple, Amalgam Rx iSage Insulin App DEMO - DiabetesMine D-Data ExChange Fall 2021, 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY I Background Information: A 510(k) Number K242066 B Applicant Amal - accessdata.fda.gov, iSage Rx: A New Type 2 Dosing App for All Major Basal Insulins - diaTribe.org, Amalgam Rx obtains CE mark for basal insulin titration app - Medical Device Network, iSage Rx - Apps on Google Play, Digital Products | Amalgam Rx
Last updated: 2026-06-23
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Press & Coverage
Videos
Product demos, reviews, and walkthroughs for iSage Rx (by Amalgam Rx).
Amalgam Rx iSage Insulin App DEMO - DiabetesMine D-Data ExChange Fall 2021
Amy Tenderich
