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mHealth Titration and Management

NCT03908762 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-04-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Kansas City Area Life Sciences Institute, Inc.

    collaborator OTHER

  • University of Kansas

    collaborator OTHER

  • LifeScan

    collaborator INDUSTRY

  • Amalgam Rx, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-12-31
Completion
2020-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03908762 on ClinicalTrials.gov