NCT03138447

A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group

A Digital Health Tool for Insulin Titration (DHIT) for Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Amalgam Rx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The digital health tool is an application ("app") available on iOS and Android enabled mobile phones. Health Care Providers ("HCPs") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. In this study, participants will be recruited from a medical practice in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on the use of the app utilizing their own mobile phone. During training, a brief self-assessment survey will be administered. After 90 days of usage, a telephone survey will be conducted. The baseline A1C results and the end of study A1C results will be collected from the patients' routine clinical care records. Data from the retrospective control group will be collected from a chart review of the same practice.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Basal Insulin Titration Application	Healthcare Providers ("HCP") and the principal investigator ("PI") will use an HCP portal to initiate a basal insulin titration algorithm. HCPs can customize the titration algorithm for every participant. Once a participant is prescribed an algorithm, they can download a mobile app on their phone with their HCPs corresponding titration plan. The app will prompt participants to enter their fasting glucose daily. Based on their fasting glucose and their HCPs titration plan, the application will display the participants daily basal insulin dose.

Timeline

• Start date: 2017-03-30
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2017-05-03
• Last updated: 2019-03-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study