Ignite Creation Date:
2024-05-06 @ 7:02 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05876273
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2023-03-24
Brief Title:
Neural-net Artificial Pancreas NAP
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Adaptive Motif-Based Control AMBC Pilot 1 - Neural Net Implementation of Automated Insulin Delivery
Status:
COMPLETED
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:
NAP
Brief Summary:
This study is intended to assess a Neural-net Artificial Pancreas NAP implementation of an established AP controller - the University of Virginia Model Predictive Control Algorithm UMPC The health outcomes achieved on NAP will be compared to the health outcomes achieved on UMPC in a randomized crossover design The investigators will consent up to 20 participants ages 180 with a goal of completing 15 participants
Detailed Description:
The study will follow a randomized cross-over design assessing glycemic control on a Neural-net Artificial Pancreas NAP compared to the previously tested University of Virginia Model Predictive Control UMPC algorithm in a supervised hotel setting
The study will involve Tandem tslim X2 Control-IQ CIQ users who will continue to use their CIQ systems except during the hotel sessions which will use the DiAs prototyping platform connected to a Tandem tAP research pump and a Dexcom G6 sensor and implementing NAP or UMPC The study sensor will be the same sensor used by CIQ - it will be disconnected from CIQ and connected to DiAs
Following enrollment one week of automated insulin delivery AID data will be downloaded from the participants pumps or tconnect accounts and will be used to establish a baseline and initialize the control algorithms Participants will be then studied at a local hotel for 20 hours including an 18-hour experiment randomly receiving either NAP or UMPC Participants will then receive the opposite intervention either sequentially during the same hotel stay or in a second hotel stay up to 28 days following the first hotel stay During these 18-hour hotel sessions participants will be followed to compare blood glucose control on NAP vs UMPC The study meals and activities will be kept the same between study sessions
The investigators will analyze non-inferiority of NAP compared to UMPC but this pilot feasibility study is not powered to formally test noninferiority The primary outcome is percent time in range TIR 70 to 180 mgdL on NAP vs UMPC Secondary outcomes include frequency of hypoglycemia time below range TBR and hyperglycemia time above range TAR as well as other safety and control metrics
The study will involve Tandem tslim X2 Control-IQ CIQ users who will continue to use their CIQ systems except during the hotel sessions which will use the DiAs prototyping platform connected to a Tandem tAP research pump and a Dexcom G6 sensor and implementing NAP or UMPC The study sensor will be the same sensor used by CIQ - it will be disconnected from CIQ and connected to DiAs
Following enrollment one week of automated insulin delivery AID data will be downloaded from the participants pumps or tconnect accounts and will be used to establish a baseline and initialize the control algorithms Participants will be then studied at a local hotel for 20 hours including an 18-hour experiment randomly receiving either NAP or UMPC Participants will then receive the opposite intervention either sequentially during the same hotel stay or in a second hotel stay up to 28 days following the first hotel stay During these 18-hour hotel sessions participants will be followed to compare blood glucose control on NAP vs UMPC The study meals and activities will be kept the same between study sessions
The investigators will analyze non-inferiority of NAP compared to UMPC but this pilot feasibility study is not powered to formally test noninferiority The primary outcome is percent time in range TIR 70 to 180 mgdL on NAP vs UMPC Secondary outcomes include frequency of hypoglycemia time below range TBR and hyperglycemia time above range TAR as well as other safety and control metrics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK133148 | NIH | None | httpsreporternihgovquickSearchR01DK133148 |