Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2026-03-07 @ 4:34 PM
Study NCT ID:
NCT03224234
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
A Randomized Study to Evaluate the Efficacy of Insulclock® in Patients With Uncontrolled Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2021-01
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:
None
Brief Summary:
Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming.
Detailed Description:
Diabetes is arguably the most urgent healthcare challenge of the 21st century. Poor adherence to insulin regimens is reported in up to two-third of patients with diabetes; thus it is important to identify patients at risk and to develop strategies and tools to increase adherence to prescribed insulin regimens. This study will evaluate the efficacy of Insulclock® - small electronic device to help track date, time and dosage of the last injection, type of insulin used and temperature, with an alarm system to prevent insulin omissions and mistiming. The Insulclock's real time memory and alert system are likely to improve treatment adherence, patient's satisfaction, and quality of life measures, which may improve glycemic control in insulin treated patients with Type 2 Diabetes.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: