Glucose Measurement Using Microneedle Patches (GUMP)

Emory University

Status: Completed

Conditions: Diabetes

Treatments: Device: Lancet; Device: Microneedle patch; Device: Intravenous (IV) catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02682056

IRB00075816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes diagnosis

Exclusion criteria

• no exclusion criteria are specified

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Single Study Arm

Other group

Description:

Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.

Treatment:

Device: Intravenous (IV) catheter

Device: Microneedle patch

Device: Lancet