NCT03353792

Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients

Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.

Detailed description

The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.

Conditions

• Type1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	CL/AP system	CL/AP system enabled insulin pump/CGM combination
DEVICE	usual diabetic care	usual diabetic care (insulin pump therapy) along with CGM recording

Timeline

• Start date: 2017-11-01
• Primary completion: 2019-08-28
• Completion: 2019-08-28
• First posted: 2017-11-27
• Last updated: 2022-11-18
• Results posted: 2022-10-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study