Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06419816
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-14
Brief Title:
Effect of Linking Data Using Smartphone Application Well Check on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus
Sponsor:
Daewoong Pharmaceutical Co LTD
Organization:
Daewoong Pharmaceutical Co LTD
Study Overview
Official Title:
A Primary Care-Based Prospective Multicenter Cluster-Randomized Pragmatic Clinical Trials to Determine the Effect of Linking Data With Investigators When Using the Electronic Health Record-Linked Smartphone Application Well Check on Clinical Outcomes in Patients With Type 2 Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This clinical study aims to evaluate the effects of using the WellCheck mobile application on blood glucose blood pressure and weight among Type 2 diabetes patients in real primary care settings It is a prospective multi-center cluster-randomized pragmatic clinical trial Patients who can use the digital healthcare mobile application without difficulty are recruited based on the clinical judgment of the attending physician
Detailed Description:
The study employs a 11 cluster-randomized allocation to differentiate between intervention physician-managed WellCheck use and control groups self-managed WellCheck use within primary care facilities where intervention and control groups are treated separately Data collection includes demographic information physical measurements vital signs laboratory tests and safety evaluations for up to 24 weeks following the initiation of WellCheck use While data collection aligns with routine clinical practice additional follow-up visits are scheduled at 6 12 18 and 24 weeks post-baseline for efficacy and safety assessments Researchers will collect necessary data based on routine clinical records and WellCheck data
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None