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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Study Arm | Other | Children and adolescents with diabetes will have blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microneedle patch | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Felner, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States | ||
| Emory Children's Center |
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Participants were enrolled between December 2017 and January 2018 from the Emory Children's Center and Children's Healthcare of Atlanta, in Atlanta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Sample collection with the different methods will occur simultaneously four times, on an hourly basis, during a single study visit. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Baseline (Hour 1), Hour 2, Hour 3, Hour 4 |
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Information about adverse events were collected from the time the study assessments began (Hour 1 on study Day 1) through the end of study procedures on study Day 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Microneedle | Microneedle patches were used to collect interstitial fluid for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Felner MD | Emory University | 404-727-7651 | efelner@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2017 | Dec 3, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D057785 | Catheters |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Intravenous (IV) catheter | Device | 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. |
|
| Lancet | Device | 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. |
|
| 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 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Intravenous Catheter | Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit. |
|
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline ( Hour 1), Hour 4 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline ( Hour 1), Hour 4 |
|
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|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Lancet | Lancets were used to collect capillary blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit. | 0 | 15 | 0 | 15 | 0 | 15 |
| EG002 | Intravenous Catheter | Intravenous catheters were used to collect venous blood for glucose testing. Participants had fasting glucose levels measured four time, on an hourly basis, during the study visit. | 0 | 15 | 0 | 15 | 0 | 15 |
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