NCT02750267

Closed-Loop Control in Young Children 5-8 Years Old Using DiAs Platform

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 5 Years – 9 Years
• Healthy volunteers: Not accepted

Summary

The overall aim of this proposed research is to determine the safety, feasibility and efficacy (AP vs at home use of SAP) of the Diabetes Assistant (DiAs) controller in day and night closed-loop control in young children 5-8 years old with type 1 diabetes over multiple 48 hours in an out-patient setting.

Detailed description

Young children with Type 1 Diabetes (T1D) in the age range of 5-8 years old are a population with clear needs but unique challenges regarding the application of artificial pancreas (AP) technologies. Young children are likely to benefit from an AP system, with current deficits in glycemic control that include both significant hypoglycemia and sub-optimal HbA1c levels; however, they have undeveloped abilities to control and interact with the AP system, posing potential safety issues. During the hours that these children are away from their parents at school and elsewhere, they lack the sophistication to operate the currently-available tools in an AP system--and may induce harm if they are allowed to do so, causing parental resistance to AP use. Commercially-available insulin pumps have mechanisms to lock access to children to prevent inappropriate insulin-delivery. However, the AP is more complex than an insulin pump, both in requiring more detailed setting information (that a child could adversely alter) and in providing alerts for impending low- and high-blood glucose (BG) levels (that one wouldn't want to lock out to child use). These functions are all run via a platform on a smart phone-a device with which young children may already feel a high degree of familiarity and thus be more likely to attempt to explore and potentially change settings. It is likely that young children will benefit the most from a system that gives them access to some AP features but provides access to other features only for their parents. In this sense, young children require a device that is not user-centered as much as family-centered. A redesign of the system to provide appropriate access to AP tools-in which certain users can obtain access to certain functionalities-is direly needed before children in this age range can benefit from the improvements in blood glucose (BG) control that the AP has to offer.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Diabetes Assistant (DiAs) with Closed-Loop	All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.

Timeline

• Start date: 2016-05-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2016-04-25
• Last updated: 2017-07-24
• Results posted: 2017-06-23

Locations

1 site across 1 country: United States