Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-27 @ 11:38 PM
Study NCT ID:
NCT03999268
Status:
COMPLETED
Last Update Posted:
2022-07-08
First Post:
2019-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Start Therapy Application With Resources and Training
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Evaluation of Insulin Start Therapy Application With Resources and Training (I-START) to Address Barriers to Insulin Therapy
Status:
COMPLETED
Status Verified Date:
2022-07
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:
I-START
Brief Summary:
The purpose of the I-START study is to evaluate an educational phone application (app) designed to support patients with type 2 diabetes (T2DM) by reinforcing the necessary skills needed for insulin administration as part of diabetes self-management.
Detailed Description:
Despite advances in technology and delivery systems, patients with T2DM continue to be reluctant to begin and adhere to insulin therapy for a variety of reasons. Introducing insulin therapy is particularly problematic during a hospitalization or a brief routine outpatient visit given time and resource constraints. Teaching people to administer an insulin injection requires time and ongoing support. Therefore, this study aims to evaluate an educational phone application designed to support patients with T2DM by reinforcing skills and self-management behaviors needed for insulin administration. Patients with T2DM who are starting insulin or need updated instruction on insulin will be invited to participate in this study to examine the effect of the phone app on psychological barriers to insulin as well as patient and provider satisfaction with and usability of the phone app in both outpatient and hospital settings.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: