Neural-net Artificial Pancreas (NAP) (NAP)

July 8, 2024 updated by: Boris Kovatchev, PhD, University of Virginia

Adaptive Motif-Based Control (AMBC): Pilot 1 - Neural Net Implementation of Automated Insulin Delivery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia Center for Diabetes Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18.0 at time of consent.
  2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year.
  3. Currently using insulin for at least six months.
  4. Currently using the Control-IQ automated insulin delivery system for at least one mont.
  5. Hemoglobin A1c of ≤9%.
  6. Using insulin parameters such as insulin to carb ratio and correction factor consistently in order to dose insulin for meals or corrections.
  7. Access to internet and willingness to upload data during the study as needed.
  8. If female of childbearing potential and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential within 24 hours prior to initiating the experimental algorithms. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  9. Willingness to use the University of Virginia Diabetes Assistant system throughout study session.
  10. Willingness to use personal Lispro (Humalog) or aspart (Novolog) during the study session.
  11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including Sodium-glucose cotransporter-2 inhibitors, metformin/biguanides, glucagon-like peptide-1 receptor agonists, Pramlintide, Dipeptidyl peptidase-4 inhibitors, Sulfonylureas and nutraceuticals).
  12. Willingness to reschedule the hotel portion of the study if placed on systemic steroids (e.g. intravenous injection, intramuscular injection, intra-articular or oral routes).
  13. An understanding and willingness to follow the protocol and signed informed consent.

Exclusion Criteria:

  1. History of Diabetic Ketoacidosis (DKA) in the 12 months prior to enrollment.
  2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
  3. Currently pregnant or intent to become pregnant during the trial.
  4. Currently breastfeeding.
  5. Currently being treated for a seizure disorder.
  6. Treatment with Meglitinides/Sulfonylureas at the time of hotel study.
  7. Use of metformin/biguanides, glucagon-like peptide-1 agonists, Pramlintide, Dipeptidyl peptidase-4 inhibitors, Sodium-glucose cotransporter-2 inhibitors, or nutraceuticals intended for glycemic control with a change in dose in the past month.
  8. History of significant cardiac arrhythmia (except for benign premature atrial contractions and benign premature ventricular contractions which are permitted or previous ablation of arrhythmia without recurrence which may be permitted) or active cardiovascular disease.

  9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

    1. Inpatient psychiatric treatment in the past 6 months.
    2. Presence of a known adrenal disorder.
    3. Uncontrolled thyroid disease.
  10. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NAP first, then UMPC
Participants will use the Neural Net Artificial Pancreas (NAP) algorithm for 18 hours. Then switch to the University of Virginia Model-Predictive Control (UMPC) for 18 hours.
Device: Neural-net Artificial Pancreas
NAP is a neural-net implementation of the previously tested UMPC algorithm (below).
Other Names:
  • NAP
Device: University of Virginia Model Predictive Control
A previously tested artificial pancreas control algorithm, based on a differential-equation model of the human metabolic system in diabetes.
Other Names:
  • UMPC
Experimental: UMPC first, then NAP
Participants will use the UMPC for 18 hours, then switch to NAP for 18 hours.
Device: Neural-net Artificial Pancreas
NAP is a neural-net implementation of the previously tested UMPC algorithm (below).
Other Names:
  • NAP
Device: University of Virginia Model Predictive Control
A previously tested artificial pancreas control algorithm, based on a differential-equation model of the human metabolic system in diabetes.
Other Names:
  • UMPC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Time-in-Range (TIR) on NAP Versus UMPC.
Time Frame: 36 hours (two 18-hour experiments)
The primary outcome is percent of time in 70 to 180 mg/dL range on NAP vs UMPC.
36 hours (two 18-hour experiments)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Time in Hyperglycemia.
Time Frame: 36 hours (two 18-hour experiments)
Percent CGM readings above 180 mg/dL.
36 hours (two 18-hour experiments)
Percent of Time in Hypoglycemia.
Time Frame: 36 hours (two 18-hour experiments)
Percent CGM readings below 70 mg/dL.
36 hours (two 18-hour experiments)
System Functionality
Time Frame: 36 hours (two 18-hour experiments)
The investigator will observe, record, and tabulate any system malfunctions requiring study team intervention.
36 hours (two 18-hour experiments)
Participant Feedback
Time Frame: 36 hours (two 18-hour experiments)
The investigator will obtain qualitative feedback form the participants regarding system functionality.
36 hours (two 18-hour experiments)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Sue A Brown, MD, University of Virginia Center for Diabetes Technology
  • Study Director: Boris P Kovatchev, PhD, University of Virginia Center for Diabetes Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2023

Primary Completion (Actual)

September 8, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

March 24, 2023

First Submitted That Met QC Criteria

May 16, 2023

First Posted (Actual)

May 25, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 8, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 230058
  • R01DK133148 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.

IPD Sharing Time Frame

Generally, data will be made available after the primary publications of each study.

IPD Sharing Access Criteria

The Data Sharing Agreements will be formulated by the study team.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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