NCT03908762

mHealth Titration and Management

Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Amalgam Rx, Inc. · Industry
• Sex: All
• Age: 21 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The principal objective of this application is to improve glycemic control of diabetic patients treated with basal insulin through use of an innovative, FDA-cleared smartphone-based insulin titration application connected to Bluetooth enabled glucose meters. iSage Rx (isageapp.com) allows providers to prescribe basal insulin treatment plans to patients and manages basal insulin doses utilizing clinically proven algorithms. In this pilot study, we hypothesize that this user-friendly application and seamless data capture will improve glycemic control (achieve HgbA1c \<7%) and reduce the frequency and severity of hypoglycemia. Exploratory measures will include healthcare resource utilization and patient and provider satisfaction. The basal insulin titration algorithms used in iSage have had thousands of user-years' experience in FDA-mandated, closely supervised clinical trials, both for long-acting insulins (e.g., Lantus, Levemir) that have been available for a long time and for the newer ultra-long-acting ones (e.g., Tresiba, Toujeo). However, the effectiveness of iSage with a connected glucose meter has not been studied in a "real world" clinical environment. Broad use of such an application and connected devices will, we believe, prove to be cost-effective, favor early and appropriate prescription of insulin, reduce provider effort, shorten time to achieve glycemic goals, and simplify the transition to basal insulin therapy.

Conditions

• Diabetes Mellitus, Type 2
• Diabetic Complication

Interventions

Type	Name	Description
DEVICE	iSage App with connected glucometer	Providers prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration.
BEHAVIORAL	Magnet	Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-12-01
• Completion: 2020-03-01
• First posted: 2019-04-09
• Last updated: 2019-04-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study