Yale-Harvard Hotel-based Closed-Loop Studies in Children

Trial Purpose and Description

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.

Ages: 2 - 17 years

Gender: Both


Eligibility Criteria

Inclusion criteria:

1)         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

2)         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

3)         A1c level ≤ 10.0%

4)         Use of insulin pump and carbohydrate counting for ≥ 3 months

5)         Average total daily insulin dose of at least 10 units/day

6)         Current or past use of CGM is desirable but NOT required

7)         Normal renal function as measured within 6 months of enrollment

8)         Normal thyroid function within 6 months of enrollment, or if previously diagnosed with hypothyroidism, documented within 3 months of enrollment

9)         Parent/guardian agrees to stay at hotel with subject for duration of hotel phase and has cell phone that can send/receive text messages

10)       Subject and participating parent/guardian speak and comprehend English

 

Exclusion criteria:

1)         Episode of diabetic ketoacidosis (DKA) within 6 months of enrollment

2)         Episode of severe hypoglycemia (seizure, loss of consciousness) within 6 months of enrollment

3)         Use of medications (other than insulin) known to affect BG levels within 4 weeks of enrollment – examples include systemic glucocorticoids, metformin, pramlintide, liraglutide, SGLT inhibitors)

4)         Current use of other medications, that in opinion of investigator, would interfere with safety or effectiveness of the study including acetaminophen

5)         Medical disorder, that in opinion of investigator, would be contraindication for inclusion; hypothyroidism and celiac disease OK if under good control

6)         Female subjects of childbearing potential unwilling to have pregnancy testing

7)         Female subject currently pregnant or lactating

8)         History of alcohol or drug abuse, documented eating disorder, or inpatient psychiatric treatment within 6 months of enrollment

9)         Subject is currently participating in another research study involving an investigational drug or device

 


National Institute of Diabetes and Digestive & Kidney Diseases

Start Date: 09/01/2018

End Date: 10/31/2019

Last Updated: 10/22/2018

Study HIC#: 1609018413

Get Involved

For more information about this study, contact:
Lori Carria
+1 203-737-3595
lori.carria@yale.edu

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Stuart Weinzimer

Principal Investigator

Sub-Investigators