Neural-net Artificial Pancreas (NAP)

Status Completed

Clinical Trial 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 ≥18.0, with a goal of completing 15 participants.

Clinical Trial 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 t:slim 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 t:AP 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 t:connect 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 mg/dL) 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05876273
Study type	Interventional
Source	University of Virginia
Contact
Status	Completed
Phase	N/A
Start date	May 30, 2023
Completion date	September 10, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neural-net Artificial Pancreas (NAP) — NAP

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms