Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-01 @ 4:28 PM
Study NCT ID:
NCT01364350
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2011-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Study Overview
Official Title:
TODAY2 Phase 1 Immediate Post-Intervention Observational Follow-up Study of the TODAY Clinical Trial Cohort
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T2P1
Brief Summary:
The purpose of this study is to continue to follow participants in the TODAY clinical trial as they transition to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months (phase 1), during which time the TODAY data are analyzed and findings interpreted to develop a long-term observational protocol (phase 2). Data are collected during phase 1 for descriptive purposes; there is no primary hypothesis.
Detailed Description:
TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) was a multi-center study of the optimal approach to treatment of type 2 diabetes (T2D) in children and adolescents. The TODAY clinical trial of experimental interventions ended in February 2011. It is followed by TODAY2, a longitudinal study to continue the care and observation of the TODAY cohort beyond the end of the TODAY intervention trial. TODAY2 consists of two phases.
1. First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
2. The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.
The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:
* understand the persistence of the effects of the different treatment regimens used in TODAY,
* describe the continued evolution of beta cell function, and
* describe the development of vascular complications and risk factors for complications.
1. First is the immediate transition of TODAY participants to non-blinded, non-randomized standard diabetes care and management with monitoring and follow-up for up to 24 months. During this period, the findings of TODAY are analyzed and interpreted by the study group.
2. The second phase is a protocol for long-term longitudinal follow-up of the TODAY cohort, based on findings from TODAY.
The primary objective of the first phase of TODAY2 is to continue to follow the TODAY subjects for up to 24 months in order to begin to:
* understand the persistence of the effects of the different treatment regimens used in TODAY,
* describe the continued evolution of beta cell function, and
* describe the development of vascular complications and risk factors for complications.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: