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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
MODEL Clinical Research
Towson, Maryland, United States
Basal Insulin Dose
Change in basal insulin dose from entry into study to completion of study.
Time frame: 90 days
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.
Time frame: 90 days
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.
Time frame: 90 days
Titration Adherence
Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.
Time frame: 90 days
Change in A1C
Change in hemoglobin A1C measure at the completion of the study as compared to baseline.
Time frame: 90 days
Change in Diabetes Distress
Change in measures of diabetes distress at the completion of the study as compared to baseline.
Time frame: 90 days
Participant Satisfaction
Demonstration of satisfaction with the app at the completion of the study.
Time frame: 90 days
Office Contacts
Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.
Time frame: 90 days
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