Glucose Measurement Using Microneedle Patches (GUMP)

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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)

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

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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