NCT02682056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable diabetes

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 10, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 21, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2018

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

January 3, 2020

Completed
Last Updated

January 3, 2020

Status Verified

December 1, 2019

Enrollment Period

1 month

First QC Date

February 10, 2016

Results QC Date

December 16, 2019

Last Update Submit

December 16, 2019

Conditions

Diabetes

Keywords

PediatricsEndocrinologyAdolescentMicroneedle

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)

    Baseline ( Hour 1), Hour 4

  • Pain Level Assessed by Pain Visual Analog Scale (VAS)

    Baseline ( Hour 1), Hour 4

Study Arms (1)

Single Study Arm

OTHER

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

Device: Microneedle patchDevice: Intravenous (IV) catheterDevice: Lancet

Interventions

Microneedle patchDEVICE

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.

Single Study Arm
Intravenous (IV) catheterDEVICE

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.

Single Study Arm
LancetDEVICE

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.

Single Study Arm

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diabetes diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory Children's Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Catheters

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Results Point of Contact

Title
Eric Felner MD
Organization
Emory University
efelner@emory.edu
404-727-7651

Study Officials

  • Eric Felner, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 10, 2016

First Posted

February 15, 2016

Study Start

December 21, 2017

Primary Completion

January 29, 2018

Study Completion

January 29, 2018

Last Updated

January 3, 2020

Results First Posted

January 3, 2020

Record last verified: 2019-12

Locations

US(2)