Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411548
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-03
Brief Title:
Insulearn Feasibility With MDI
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Feasibility of a Bolus Calculator Without Carbohydrate Counting in T1D Patients Under MDI Therapy A Supervised Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
InsuLearn
Brief Summary:
This is a 24-hour randomized crossover single-center trial where participants are randomized to either start with the InsuLearn intervention or the usual care UC intervention In the InsuLearn intervention insulin doses are optimized using data collected in a 4-weeks at home data collection period
Detailed Description:
Following recruitment and screening 12 participants will be randomized to either the InsuLearnUC or the UCInsuLearn sequence Participants will be trained in the use of CGM Dexcom G6 or Guardian 4 smart insulin pen SIP InPen Medtronic and the InPen bolus calculator phone application The InPen application will be set to the meal estimation mode where the user can select the meal category if it is a breakfastlunchdinnersnack and if it has lowmedhigh carb amount During the one-month data collection period participants will be asked to use the InPen app to log and deliver their insulin doses Before the hotel admission InsuLearn will analyze the collected data to learn a new optimized insulin dose for each meal category InsuLearn will generate a report of suggested new insulin doses that will be reviewed approved or changed by the study physician as needed In the 24-h supervised interventions hotel admission the participant will consume three standardized meals a med-carb lunch a high-carb dinner and low-carb breakfast The insulin dose delivered in each admission will be either calculated by participants as per their UC or is as provided by the InsuLearn approved report The two interventions are combined into a 2-day admission without a washout period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None