mHealth Titration and Management

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03908762
• Other study ID #: 00142758
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: March 2020

Study information

• Verified date: April 2019
• Source: Amalgam Rx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetic Complication

Intervention

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.

Locations

Country	Name	City	State
United States	Cray Diabetes Self-Management Center	Kansas City	Kansas

Sponsors (4)

Lead Sponsor	Collaborator
Amalgam Rx, Inc.	Kansas City Area Life Sciences Institute, Inc., LifeScan, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1C	Mean and Median Change from Baseline	3 Months
Secondary	A1C in Target	Percentage of patients with an A1C < 7	Baseline to 3 months
Secondary	Rate of Hypoglycemia	Percentage of glucose readings <70	Baseline to 3 months