Neural-net Artificial Pancreas (NAP) (NAP)
Type1 Diabetes
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
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
Experimental
Experimental
NAP first, then UMPC
UMPC first, then NAP
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.