NCT05592860

Comparison of Glycemic Control With Smartphone Application

Comparison of Glycemic Control With Smartphone Application (Vivovitals) - Based Glucose Monitoring to Routine Home Glucose Monitoring in Poorly Controlled T2DM Patients Treated With Insulin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is aimed to determine if a smartphone application based weekly glucose monitoring by a care provider is superior to the routine home glucose monitoring by patients in poorly controlled type 2 diabetes mellitus who are on insulin.

Detailed description

The study is a randomized, prospective cohort study. Subjects will be enrolled randomly after fulfilling the meeting criteria into two groups. Group 1 (intervention group) will used mobile application to enter their glucose level and group 2 (control group) will record their glucose level on daily diary. Data collection will be standardized in order to eliminate bias. In addition, all statistical analyses will be performed by a departmental statistician and not the study investigators. Patients in each arm of the study will be selected form the same population in order to avoid selection bias.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Mobile application	participants in intervention group will use smart phone application and update glucose level and investigator will adjust the insulin accordingly
BEHAVIORAL	Daily Diary	participants will use daily diary to record glucose level

Timeline

• Start date: 2021-07-10
• Primary completion: 2021-12-02
• Completion: 2021-12-02
• First posted: 2022-10-25
• Last updated: 2022-10-25

Locations

1 site across 1 country: United States