Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-01-04 @ 7:58 PM
Study NCT ID:
NCT02682056
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Glucose Measurement Using Microneedle Patches
Sponsor:
Emory University
Organization:
Study Overview
Official Title:
Glucose Measurement Using Microneedle Patches
Status:
COMPLETED
Status Verified Date:
2019-12
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:
GUMP
Brief Summary:
This study will compare three glucose measurement techniques among diabetic children and adolescents. The study seeks to determine if a microneedle patch (made from biocompatible polymers or metal), versus a lancet or intravenous catheter, would be a preferable option for monitoring glucose levels among the diabetic pediatric population.
Detailed Description:
Fifteen children and adolescents with diabetes will be tested for their glucose measurements comparing interstitial fluid collected via a microneedle patch (made from biocompatible polymers or metal), versus the standard of care blood sample (lancet), and lab grade blood draw (intravenous catheter). Samples will be taken hourly from all three devices for four hours. All four measurements will be compared against each other to see how close they are with measuring the glucose values. Each participant will be asked to rate their apprehension prior to receiving each method for blood or interstitial fluid collection as well as the pain associated with each method immediately after collection.
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?:
None
Is an FDA AA801 Violation?: