Yale-Harvard Hotel-based Closed-Loop Studies in Children (HY-GRAID)

Yale University

Status

Completed

Conditions

Type1 Diabetes

Treatments

Device: Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)

Study type

Interventional

Funder types

Other

Identifiers

NCT04255381

1609018413

Details and patient eligibility

About

The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.

Full description

The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise.

The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents.

Enrollment

20 patients

Sex

All

Ages

2 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 2- <18 years; for first cohort(s), subjects will be 12-17 years; additional age brackets will be 8-11 years and then <8 years
Type 1 diabetes for ≥ 1 year duration - the diagnosis of type 1 diabetes will be based on the history of ketosis/ketoacidosis at diagnosis or laboratory evidence of islet-cell auto-immunity
A1c level ≤ 10.0%
Use of insulin pump and carbohydrate counting for ≥ 3 months
Average total daily insulin dose of at least 10 units/day
Current or past use of Continuous Glucose Monitoring (CGM) is desirable but NOT required
Normal renal function as measured within 6 months of enrollment
Normal thyroid function within 6 months of enrollment, or if previously diagnosed with hypothyroidism, documented within 3 months of enrollment
Parent/guardian agrees to stay at hotel with subject for duration of hotel phase and has cell phone that can send/receive text messages
Subject and participating parent/guardian speak and comprehend English

Exclusion criteria

Episode of diabetic ketoacidosis (DKA) within 6 months of enrollment
Episode of severe hypoglycemia (seizure, loss of consciousness) within 6 months of enrollment
Use of medications (other than insulin) known to affect BG levels within 4 weeks of enrollment - examples include systemic glucocorticoids, metformin, pramlintide, liraglutide)
Current use of other medications, that in opinion of investigator, would interfere with safety or effectiveness of the study including acetaminophen
Medical disorder, that in opinion of investigator, would be contraindication for inclusion; hypothyroidism and celiac disease are NOT exclusion if under good control
Female subjects of childbearing potential unwilling to have pregnancy testing
Female subject currently pregnant or lactating
History of alcohol or drug abuse, documented eating disorder, or inpatient psychiatric treatment within 6 months of enrollment
Subject is currently participating in another research study involving an investigational drug or device