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mHealth Titration and Management

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

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

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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

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.




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908762


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

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