Diabetes
Conditions
Keywords
Pediatrics, Endocrinology, Adolescent, Microneedle
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.
Interventions
DEVICEMicroneedle patch
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.
DEVICEIntravenous (IV) catheter
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.
DEVICELancet
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.
Sponsors
Emory University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diabetes diagnosis
Exclusion criteria
* no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between December 2017 and January 2018 from the Emory Children's Center and Children's Healthcare of Atlanta, in Atlanta, Georgia.
Participants by arm
| Arm | Count |
|---|---|
| Children Having Glucose Levels Tested Through Three Methods Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Children Having Glucose Levels Tested Through Three Methods |
|---|---|
| Age, Categorical <=18 years | 11 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 16.8 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: Baseline (Hour 1), Hour 2, Hour 3, Hour 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Microneedle | Glucose Level | Baseline/Hour 1 | 137 mg/dL | Standard Deviation 119 |
| Microneedle | Glucose Level | Hour 2 | 155 mg/dL | Standard Deviation 78 |
| Microneedle | Glucose Level | Hour 3 | 256 mg/dL | Standard Deviation 224 |
| Microneedle | Glucose Level | Hour 4 | 285 mg/dL | Standard Deviation 126 |
| Lancet | Glucose Level | Hour 4 | 276.4 mg/dL | Standard Deviation 122.9 |
| Lancet | Glucose Level | Baseline/Hour 1 | 174.5 mg/dL | Standard Deviation 58 |
| Lancet | Glucose Level | Hour 3 | 270.4 mg/dL | Standard Deviation 82 |
| Lancet | Glucose Level | Hour 2 | 271.4 mg/dL | Standard Deviation 91 |
| Intravenous Catheter | Glucose Level | Hour 4 | 251.5 mg/dL | Standard Deviation 122.9 |
| Intravenous Catheter | Glucose Level | Hour 2 | 227.3 mg/dL | Standard Deviation 65 |
| Intravenous Catheter | Glucose Level | Hour 3 | 270.4 mg/dL | Standard Deviation 82 |
| Intravenous Catheter | Glucose Level | Baseline/Hour 1 | 160.9 mg/dL | Standard Deviation 58 |
Secondary
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.
Time frame: Baseline ( Hour 1), Hour 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Microneedle | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Baseline/Hour 1 | 24.1 units on a scale | Standard Deviation 23 |
| Microneedle | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Hour 4 | 12.2 units on a scale | Standard Deviation 14.1 |
| Lancet | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Baseline/Hour 1 | 5.8 units on a scale | Standard Deviation 16.9 |
| Lancet | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Hour 4 | 4.9 units on a scale | Standard Deviation 15.3 |
| Intravenous Catheter | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Baseline/Hour 1 | 30.8 units on a scale | Standard Deviation 24.7 |
| Intravenous Catheter | Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS) | Hour 4 | 24.4 units on a scale | Standard Deviation 20.6 |
Secondary
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.
Time frame: Baseline ( Hour 1), Hour 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Microneedle | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Baseline/Hour 1 | 22.5 units on a scale | Standard Deviation 22 |
| Microneedle | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Hour 4 | 11.2 units on a scale | Standard Deviation 13.5 |
| Lancet | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Baseline/Hour 1 | 5.8 units on a scale | Standard Deviation 16.9 |
| Lancet | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Hour 4 | 4.4 units on a scale | Standard Deviation 14.4 |
| Intravenous Catheter | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Baseline/Hour 1 | 33.4 units on a scale | Standard Deviation 24.3 |
| Intravenous Catheter | Pain Level Assessed by Pain Visual Analog Scale (VAS) | Hour 4 | 26.8 units on a scale | Standard Deviation 21.1 |