Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT03353792
Status:
TERMINATED
Last Update Posted:
2022-11-18
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
Status:
TERMINATED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Initial difficulty with recruitment was exasperated by COVID pause of the study and then the end of funding.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T1DM AP
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01DK101984-01A1 | NIH | None | https://reporter.nih.gov/quic… | View |
| 1DP3DK112227-01 | NIH | None | https://reporter.nih.gov/quic… | View |