mHealth Titration and Management

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Diabetic Complication
• Intervention / Treatment: Device: iSage App with connected glucometer; Behavioral: Magnet

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • Cray Diabetes Self-Management Center
      • Contact: Teri Lavenbarg; Phone Number: 913-588-6022; Email: tlavenbarg@kumc.edu
      • Principal Investigator: David Robbins
      • Sub-Investigator: Kristin Grdinovac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• T2DM (WHO criteria) treated with basal insulin (glargine, detemir, degludec)
• HgbA1c 8 or above
• GFR >60 ml/min within the last 12 months
• English speaking, informed consent
• Has an Android or iOS based compatible smartphone (iOS 9.0 or above; Android 4.4 or above)
• Currently performs at least 3 fasting fingerstick glucose measurements/week
• Have a PCP within the KU Health System

Exclusion Criteria:

• Diagnosis of hypoglycemic unawareness within 6 months of enrollment
• Diagnosis of hyperglycemic hyperosmolar non-ketotic coma (HONK) or diabetic ketoacidosis (DKA) within 6 months of enrollment
• Recent (within the last 6 months)/current use of non-topical steroids
• Insulin requirements in excess of 1U/kg per day
• Use of pioglitazone or another thiazolidinedione (TZD)
• In the opinion of the provider, HgbA1c goals should adjusted above 7% due to infirmity, unstable cardiovascular disease, etc.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iSage; The provider will choose a treatment algorithm embedded within the app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The app is downloaded by the patient while in the examination room, and the patient is instructed to perform daily fasting glucose fingerstick measurements and follow the app's recommendations for insulin adjustment. Data on telephone or visit contact with a healthcare provider will be collected via the EMR. Hypoglycemic events (defined as blood glucose <70 mg/dl, measured or perceived) are recorded in the iSage application as well as patient report. Providers are asked to review the patients transmitted blood sugar logs as necessary, and those reviews are recorded. Return visits are managed by the HCP and will be logged as resource utilization.	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.
Active Comparator: Conventional Management; Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. In the case of glargine or detemir (Basaglar, Lantus, Levemir) adjustments of 1 unit of insulin/day are made until the fasting blood sugars (2 of 3 consecutive values) are 80-130 mg/dl. In the instance of Toujeo or Tresiba, adjustments of 2 units are made every 5 days. Volunteers will have meters downloaded (or interviewed where necessary) to obtain data on fasting blood sugar and episodes of hypoglycemia (perceived or measured <70 mg/dl). The PCP is free to request glucose logs and set return appointments as needed to manage the patient.	Behavioral: Magnet; Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C	Mean and Median Change from Baseline	3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A1C in Target	Percentage of patients with an A1C < 7	Baseline to 3 months
Rate of Hypoglycemia	Percentage of glucose readings <70	Baseline to 3 months

Collaborators and Investigators

• Sponsor: Amalgam Rx, Inc.
• Collaborators: Kansas City Area Life Sciences Institute, Inc.; University of Kansas; LifeScan

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 8, 2019
• First Posted (Actual): April 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2019
• Last Update Submitted That Met QC Criteria: April 8, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Complications
• Other Study ID Numbers: 00142758

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No