Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT05592860
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2022-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glycemic Control With Smartphone Application
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: