search
Back to results

Neural-net Artificial Pancreas (NAP) (NAP)

Primary Purpose

Type1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neural-net Artificial Pancreas
University of Virginia Model Predictive Control
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1 Diabetes focused on measuring Artificial Pancreas (AP), Diabetes Mellitus, Type 1, Insulin Pump, Continuous Glucose Monitor (CGM), Model Predictive Control (MPC), Automated Insulin Delivery (AID), Adaptive Motif-based Control (AMBC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥18.0 at time of consent. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year. Currently using insulin for at least six months. Currently using the Control-IQ automated insulin delivery system for at least one mont. Hemoglobin A1c of ≤9%. Using insulin parameters such as insulin to carb ratio and correction factor consistently in order to dose insulin for meals or corrections. Access to internet and willingness to upload data during the study as needed. 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. Willingness to use the University of Virginia Diabetes Assistant system throughout study session. Willingness to use personal Lispro (Humalog) or aspart (Novolog) during the study session. 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). 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). An understanding and willingness to follow the protocol and signed informed consent. Exclusion Criteria: History of Diabetic Ketoacidosis (DKA) in the 12 months prior to enrollment. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment. Currently pregnant or intent to become pregnant during the trial. Currently breastfeeding. Currently being treated for a seizure disorder. Treatment with Meglitinides/Sulfonylureas at the time of hotel study. 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. 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. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: Inpatient psychiatric treatment in the past 6 months. Presence of a known adrenal disorder. Uncontrolled thyroid disease. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.

Sites / Locations

  • University of Virginia Center for Diabetes Technology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NAP first, then UMPC

UMPC first, then NAP

Arm Description

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.

Participants will use the UMPC for 18 hours, then switch to NAP for 18 hours.

Outcomes

Primary Outcome Measures

Percent of Time-in-Range (TIR) on NAP versus UMPC.
The primary outcome is percent of time in 70 to 180 mg/dL range on NAP vs UMPC.

Secondary Outcome Measures

Percent of Time in Hyperglycemia.
Percent CGM readings above 180 mg/dL.
Percent of Time in Hypoglycemia.
Percent CGM readings below 70 mg/dL.
System Functionality
The investigator will observe, record, and tabulate any system malfunctions requiring study team intervention.
Participant Feedback
The investigator will obtain qualitative feedback form the participants regarding system functionality.

Full Information

First Posted
March 24, 2023
Last Updated
October 19, 2023
Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
search

1. Study Identification

Unique Protocol Identification Number
NCT05876273
Brief Title
Neural-net Artificial Pancreas (NAP)
Acronym
NAP
Official Title
Adaptive Motif-Based Control (AMBC): Pilot 1 - Neural Net Implementation of Automated Insulin Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
September 8, 2023 (Actual)
Study Completion Date
September 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

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 ≥18.0, 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes
Keywords
Artificial Pancreas (AP), Diabetes Mellitus, Type 1, Insulin Pump, Continuous Glucose Monitor (CGM), Model Predictive Control (MPC), Automated Insulin Delivery (AID), Adaptive Motif-based Control (AMBC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized crossover: Participants will be randomized to two groups differing by the order of controller use: Group A: NAP, followed by UMPC; Group B: UMPC, followed by NAP.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NAP first, then UMPC
Arm Type
Experimental
Arm Description
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.
Arm Title
UMPC first, then NAP
Arm Type
Experimental
Arm Description
Participants will use the UMPC for 18 hours, then switch to NAP for 18 hours.
Intervention Type
Device
Intervention Name(s)
Neural-net Artificial Pancreas
Other Intervention Name(s)
NAP
Intervention Description
NAP is a neural-net implementation of the previously tested UMPC algorithm (below).
Intervention Type
Device
Intervention Name(s)
University of Virginia Model Predictive Control
Other Intervention Name(s)
UMPC
Intervention Description
A previously tested artificial pancreas control algorithm, based on a differential-equation model of the human metabolic system in diabetes.
Primary Outcome Measure Information:
Title
Percent of Time-in-Range (TIR) on NAP versus UMPC.
Description
The primary outcome is percent of time in 70 to 180 mg/dL range on NAP vs UMPC.
Time Frame
36 hours (two 18-hour experiments)
Secondary Outcome Measure Information:
Title
Percent of Time in Hyperglycemia.
Description
Percent CGM readings above 180 mg/dL.
Time Frame
36 hours (two 18-hour experiments)
Title
Percent of Time in Hypoglycemia.
Description
Percent CGM readings below 70 mg/dL.
Time Frame
36 hours (two 18-hour experiments)
Title
System Functionality
Description
The investigator will observe, record, and tabulate any system malfunctions requiring study team intervention.
Time Frame
36 hours (two 18-hour experiments)
Title
Participant Feedback
Description
The investigator will obtain qualitative feedback form the participants regarding system functionality.
Time Frame
36 hours (two 18-hour experiments)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18.0 at time of consent. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year. Currently using insulin for at least six months. Currently using the Control-IQ automated insulin delivery system for at least one mont. Hemoglobin A1c of ≤9%. Using insulin parameters such as insulin to carb ratio and correction factor consistently in order to dose insulin for meals or corrections. Access to internet and willingness to upload data during the study as needed. 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. Willingness to use the University of Virginia Diabetes Assistant system throughout study session. Willingness to use personal Lispro (Humalog) or aspart (Novolog) during the study session. 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). 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). An understanding and willingness to follow the protocol and signed informed consent. Exclusion Criteria: History of Diabetic Ketoacidosis (DKA) in the 12 months prior to enrollment. Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment. Currently pregnant or intent to become pregnant during the trial. Currently breastfeeding. Currently being treated for a seizure disorder. Treatment with Meglitinides/Sulfonylureas at the time of hotel study. 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. 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. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples: Inpatient psychiatric treatment in the past 6 months. Presence of a known adrenal disorder. Uncontrolled thyroid disease. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boris P Kovatchev, PhD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sue A Brown, MD
Organizational Affiliation
University of Virginia Center for Diabetes Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Center for Diabetes Technology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Neural-net Artificial Pancreas (NAP)

We'll reach out to this number within 24 hrs