DiabetesGUMPNCT02682056
Glucose Measurement Using Microneedle Patches
A study testing Microneedle patch, Intravenous (IV) catheter and Lancet in people with Diabetes, run by Emory University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Microneedle patch, Intravenous (IV) catheter and Lancet
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Dec 2017to 29 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diabetes diagnosis
Who cannot join
- no exclusion criteria are specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory Children's Center
Atlanta, Georgia, 30322
About this study
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.
Read the 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.
- Conditions
- Diabetes
- Being tested
- Microneedle patch, Intravenous (IV) catheter, Lancet
- Keywords
- Pediatrics, Endocrinology, Adolescent, Microneedle
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Single Study Arm | Other | Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. Receives: Device: Microneedle patch; Device: Intravenous (IV) catheter; Device: Lancet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Hour 1), Hour 2, Hour 3, Hour 4
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline ( Hour 1), Hour 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study start21 Dec 2017
- Primary completion29 Jan 2018
- Study completion29 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Felner, MD, MSCR, Emory University
- Investigators
- Eric Felner, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682056
- Sponsor's protocol ID
- IRB00075816
- Acronym
- GUMP
- Status last verified
- Dec 2019
- First submitted
- 10 Feb 2016
- Last updated
- 3 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Measurement Using Microneedle Patches
- ClinicalTrials.gov ID
- NCT02682056
- Acronym / sponsor ID
- GUMP / IRB00075816
- Conditions
- Diabetes
- Keywords
- Pediatrics, Endocrinology, Adolescent, Microneedle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 21 Dec 2017 (actual)
- Primary completion
- 29 Jan 2018 (actual)
- Study completion
- 29 Jan 2018 (actual)
- First posted
- 15 Feb 2016 (estimated)
- Results
- Posted 3 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Study Arm | Other | Device: Microneedle patch, Device: Intravenous (IV) catheter, Device: LancetChildren and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Diabetes diagnosis
Key exclusion criteria (1 listed)
- no exclusion criteria are specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microneedle patchThe 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. | Device | Single Study Arm |
| Intravenous (IV) catheterThe 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. | Device | Single Study Arm |
| LancetThe 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. | Device | Single Study Arm |
Primary outcome
Glucose Level
Time frame: 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.
2 secondary outcomes
Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)
Time frame: Baseline ( Hour 1), Hour 4
Pain Level Assessed by Pain Visual Analog Scale (VAS)
Time frame: Baseline ( Hour 1), Hour 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Felner, MD principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microneedle patch, Intravenous (IV) catheter and Lancet in people with Diabetes, run by Emory University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose Level (time frame: Baseline (Hour 1), Hour 2, Hour 3, Hour 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2020.