NCT03428932

Glycemic Control and the Brain in Children With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 14 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if improving diabetes control by better controlling blood sugars, will help improve or normalize brain function as compared to routine diabetes care. We will use either the patient's own insulin routine (injections or insulin pumps) or a closed-loop insulin pump (Medtronic 670G). This system uses a continuous glucose monitor (CGM) and an insulin pump to automatically give insulin and may improve control of blood sugars.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Closed Loop (Medtronic 670G)	A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
OTHER	Standard Care	Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-07-01
• Completion: 2019-07-01
• First posted: 2018-02-12
• Last updated: 2023-05-16
• Results posted: 2023-05-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study