Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501612
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-09
Brief Title:
Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App with Dexcom G7
Sponsor:
Scripps Whittier Diabetes Institute
Organization:
Scripps Whittier Diabetes Institute
Study Overview
Official Title:
Pilot RCT Evaluating Clinical Outcomes of Using Undermyfork Mobile App with Dexcom G7 in a Real-World Community Ambulatory Health Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits contributing to our understanding of the potential advantages and informing future diabetes care practices The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications Unlike standard care which often involves periodic fingerstick glucose testing and limited dietary guidance the proposed intervention offers continuous monitoring and tailored dietary insights thus potentially improving overall diabetes management outcomes The proposed intervention therefore deviates from standard care by integrating mobile health apps into the routine for CGM use offering a novel avenue for enhanced glycemic monitoring and management
Detailed Description:
The current research study seeks to determine the feasibility acceptability and effectiveness of using continuous glucose monitors CGM with and without a digital food diary Undermyfork for CGM naïve individuals with type 2 diabetes T2D in a real-world large community health setting Undermyfork as a novel digital tool integrates CGM data with meal tracking offering users insights into their dietary choices and glucose levels This innovative approach stems from the rationale that real-time continuous glucose monitoring CGM can offer valuable insights into glycemic control thereby enhancing diabetes self-management In addition while the number of free health-related mobile applications continues to increase and underscores the growing interest in leveraging technology to improve health outcomes there is a limited number of apps that are grounded in evidence This highlights the importance for clinical testing to evaluate the efficiency and practicality of mobile apps aimed at enhancing health behaviors and outcomes particularly with diabetes
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits contributing to our understanding of the potential advantages and informing future diabetes care practices The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications Unlike standard care which often involves periodic fingerstick glucose testing and limited dietary guidance the proposed intervention offers continuous monitoring and tailored dietary insights thus potentially improving overall diabetes management outcomes
This need for new and effective treatments for T2D motivates the exploration of interventions like the proposed study to integrate easy-to-access mobile technology with CGM Despite the availability of various diabetes management strategies optimizing glycemic control remains a challenge By evaluating the clinical and financial benefits of adding a mobile self-management apps to CGM technology this study contributes to addressing the unmet needs of individuals who are interested in taking an active role in their health aiming to advance our understanding of effective and patient-centered diabetes care The potential outcomes of this research can influence future practices in diabetes management benefiting individuals with T2D and contributing to the broader landscape of diabetes care
This study aims to determine if adding using a mobile diabetes-related health application with CGM device yields significant benefits contributing to our understanding of the potential advantages and informing future diabetes care practices The rationale for testing CGM with Undermyfork in individuals with T2D stems from the potential benefits of real-time glucose monitoring and personalized dietary tracking in improving glycemic control and reducing diabetes-related complications Unlike standard care which often involves periodic fingerstick glucose testing and limited dietary guidance the proposed intervention offers continuous monitoring and tailored dietary insights thus potentially improving overall diabetes management outcomes
This need for new and effective treatments for T2D motivates the exploration of interventions like the proposed study to integrate easy-to-access mobile technology with CGM Despite the availability of various diabetes management strategies optimizing glycemic control remains a challenge By evaluating the clinical and financial benefits of adding a mobile self-management apps to CGM technology this study contributes to addressing the unmet needs of individuals who are interested in taking an active role in their health aiming to advance our understanding of effective and patient-centered diabetes care The potential outcomes of this research can influence future practices in diabetes management benefiting individuals with T2D and contributing to the broader landscape of diabetes care
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