Glucose Measurement Using Microneedle Patches

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Microneedle patch; Device: Intravenous (IV) catheter; Device: Lancet

• Registration Number: NCT02682056
• Lead Sponsor: Emory University

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 Timeline

• Study First Submitted: 2016-02-10
• Study First Submitted QC: 2016-02-10
• Study First Posted: 2016-02-15
• Study Start: 2017-12-21
• Primary Completion: 2018-01-29
• Study Completion: 2018-01-29
• Disposition First Submitted: 2019-01-14
• Disposition First Submitted QC: 2019-01-14
• Disposition First Posted: 2019-01-18
• Status Verified: 2019-12
• Results First Submitted: 2019-12-16
• Results First Submitted QC: 2019-12-16
• Last Update Submitted: 2019-12-16
• Results First Posted: 2020-01-03
• Last Update Posted: 2020-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Diabetes diagnosis

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Exclusion Criteria

• no exclusion criteria are specified

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Study Arm	Intravenous (IV) catheter	Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.
Single Study Arm	Lancet	Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.
Single Study Arm	Microneedle patch	Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.

Primary Outcome Measures

Name	Time	Method
Glucose Level	Baseline (Hour 1), Hour 2, Hour 3, Hour 4	Participants had their glucose levels tested through three different methods. Interstitial glucose levels was assessed using a microneedles patch. Blood glucose levels were collected via the lancet and intravenous (IV) collection methods.

Secondary Outcome Measures

Name	Time	Method
Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)	Baseline ( Hour 1), Hour 4	Participants completed a Visual Analog Scale (VAS) to report the level of apprehension they felt regarding each method of sample collection. Participants will mark on a line scale (between not afraid and very afraid) to indicate fear level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no apprehension and 100 mm indicating the most apprehension.
Pain Level Assessed by Pain Visual Analog Scale (VAS)	Baseline ( Hour 1), Hour 4	Participants completed a Visual Analog Scale (VAS) to report the level of pain they felt regarding each method of sample collection. Participants marked on a line scale (between no pain and worst pain ever) to indicate pain level when a sample is collected. The range is from 0-100 mm with 0 mm indicating no pain and 100 mm indicating the most extreme pain.

Trial Locations

Locations (2)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Emory Children's Center; 🇺🇸 Atlanta, Georgia, United States