mHealth Titration and Management

• ClinicalTrials.gov Identifier: NCT03908762
• Recruitment Status: Unknown
• First Posted: April 9, 2019
• Last Update Posted: April 9, 2019
• Sponsor: Amalgam Rx, Inc.
• Collaborators: Kansas City Area Life Sciences Institute, Inc.; University of Kansas; LifeScan
• Information provided by (Responsible Party): Amalgam Rx, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2; Diabetic Complication	Device: iSage App with connected glucometer; Behavioral: Magnet	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration
• Actual Study Start Date: January 1, 2019
• Estimated Primary Completion Date: December 2019
• Estimated Study Completion Date: March 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change in A1C [ Time Frame: 3 Months ]
   Mean and Median Change from Baseline

Secondary Outcome Measures :

1. A1C in Target [ Time Frame: Baseline to 3 months ]
   Percentage of patients with an A1C < 7
2. Rate of Hypoglycemia [ Time Frame: Baseline to 3 months ]
   Percentage of glucose readings <70

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Kansas

Cray Diabetes Self-Management Center; Recruiting

Kansas City, Kansas, United States, 66160

Contact: Teri Lavenbarg 913-588-6022 tlavenbarg@kumc.edu

Principal Investigator: David Robbins

Sub-Investigator: Kristin Grdinovac

Sponsors and Collaborators

Amalgam Rx, Inc.

Kansas City Area Life Sciences Institute, Inc.

University of Kansas

LifeScan

More Information

• Responsible Party: Amalgam Rx, Inc.
• ClinicalTrials.gov Identifier: NCT03908762
• Other Study ID Numbers: 00142758
• First Posted: April 9, 2019
• Last Update Posted: April 9, 2019
• Last Verified: April 2019

• 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

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2; Diabetes Complications; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases