Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-29 @ 2:26 AM
Study NCT ID:
NCT04439903
Status:
COMPLETED
Last Update Posted:
2024-11-14
First Post:
2020-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Sponsor:
University of Virginia
Organization:
Study Overview
Official Title:
Web-Based Simulation Tool For Self-Management Support In Type 1 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2024-10
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:
WST
Brief Summary:
This project focuses on embedding the participants' own diabetes data into state-of-the-art technology platforms to constitute a novel educational simulation interface for decision-support in Type 1 Diabetes (T1D) - the Web-based Simulation Tool (WST).
Detailed Description:
The Web-based Simulation Tool (WST) allows patients with Type 1 Diabetes (T1D) to not only visualize their data, but also to explore changes to their meals and insulin parameters, and easily estimate their potential clinical impact. WST is an educational tool, and as such, it does not have prescriptive power. This platform collects glucose, insulin and meal data from the participants' insulin pump, and generates personalized models of their glucose metabolism. Both data collection and model personalization are backend processes, that is, without user intervention.
Participants can interact with WST through a user interface (UI) that is equipped with a dashboard page, where they can:
(i) select a particular date range using a calendar to visualize their historical glucose control, such as glucose traces, and time in range;
(ii) control the amount of information on the screen - users can show/hide more details, such as glucose variability;
(iii) select different insulin therapy parameters: basal rate, insulin sensitivity factor, and carbohydrate ratio;
(iv) change their values by moving a slider;
(v) select informed meals within the selected date range, and modify their time and size by moving a slider;
(vi) run a simulation with the modified insulin therapy parameters and meals by tapping a button;
(vii) save the insulin and meal settings of the simulations to compare multiple configurations; and
(viii) generate a report from the selected simulation, comparing both original and simulated or replay data.
Participants can interact with WST through a user interface (UI) that is equipped with a dashboard page, where they can:
(i) select a particular date range using a calendar to visualize their historical glucose control, such as glucose traces, and time in range;
(ii) control the amount of information on the screen - users can show/hide more details, such as glucose variability;
(iii) select different insulin therapy parameters: basal rate, insulin sensitivity factor, and carbohydrate ratio;
(iv) change their values by moving a slider;
(v) select informed meals within the selected date range, and modify their time and size by moving a slider;
(vi) run a simulation with the modified insulin therapy parameters and meals by tapping a button;
(vii) save the insulin and meal settings of the simulations to compare multiple configurations; and
(viii) generate a report from the selected simulation, comparing both original and simulated or replay data.
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?:
None
Is an FDA AA801 Violation?: