Glucose Measurement Using Microneedle Patches

Study Overview
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Brief Summary
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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
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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.

Official Title
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Glucose Measurement Using Microneedle Patches

Conditions
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Diabetes

Intervention / Treatment
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* Device: Microneedle patch
* Device: Intravenous (IV) catheter
* Device: Lancet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes diagnosis Exclusion Criteria: no exclusion criteria are specified

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Study Arm<br>Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. | Device: Microneedle patch<br>* The microneedle patch will collect interstitial fluid to be tested for glucose level. The microneedles are made from biocompatible polymers or metal. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.<br>Device: Intravenous (IV) catheter<br>* The intravenous (IV) catheter will collect venous blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.<br>Device: Lancet<br>* The lancet will collect capillary blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose Level | 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. | Baseline (Hour 1), Hour 2, Hour 3, Hour 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | 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. | Baseline ( Hour 1), Hour 4 | 
| Pain Level Assessed by Pain Visual Analog Scale (VAS) | 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. | Baseline ( Hour 1), Hour 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics, Endocrinology, Adolescent, Microneedle