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

Diabetes Mellitus, Type 2 Clinical Trial

— DHIT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138447
• Other study ID #: IS001
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: January 30, 2019

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Prospective cohort: The participants will be patients with type 2 diabetes mellitus who are not at goal on their current dose of prescribed basal insulin (e.g. Lantus, Toujeo, Levemir, Tresiba, or Basaglar). Participants shall be age 21 or older, prescribed basal insulin within the past 18 months, own a compatible mobile phone, able to receive/make calls and read messages on their phone. There is no predefined gender or ethnic group. Participants should be generally healthy and not expected to be hospitalized for surgery or other medical care during the study period.

• Retrospective cohort: This will be a chart review. Participants will be matched to the prospective cohort for age, gender and baseline A1C. Patients should have been prescribed one of the basal insulins above.

Exclusion Criteria:

• Prospective cohort: Participants with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses during the study period, severe visual impairment, or dementia will be excluded. Also, participants prescribed rapid-acting or premixed insulins (any insulin not on the above list) will be excluded.

• Retrospective cohort: Same as above.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	MODEL Clinical Research	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Amalgam Rx, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basal Insulin Dose	Change in basal insulin dose from entry into study to completion of study.	90 days
Secondary	Change in Fasting Glucose	Change in the average fasting blood glucose in the final week of the study as compared to the first week of the study.	90 days
Secondary	Fasting Glucose in Target	Proportion of participants whose fasting blood glucose is in the ADA target range by the end of the 90 day study period.	90 days
Secondary	Titration Adherence	Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.	90 days
Secondary	Change in A1C	Change in hemoglobin A1C measure at the completion of the study as compared to baseline.	90 days
Secondary	Change in Diabetes Distress	Change in measures of diabetes distress at the completion of the study as compared to baseline.	90 days
Secondary	Participant Satisfaction	Demonstration of satisfaction with the app at the completion of the study.	90 days
Secondary	Office Contacts	Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.	90 days