Trial Outcomes & Findings for Glucose Measurement Using Microneedle Patches (NCT NCT02682056)
NCT ID: NCT02682056
Last Updated: 2020-01-03
Results Overview
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.
COMPLETED
NA
15 participants
Baseline (Hour 1), Hour 2, Hour 3, Hour 4
2020-01-03
Participant Flow
Participants were enrolled between December 2017 and January 2018 from the Emory Children's Center and Children's Healthcare of Atlanta, in Atlanta, Georgia.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucose Measurement Using Microneedle Patches
Baseline characteristics by cohort
| Measure |
Children Having Glucose Levels Tested Through Three Methods
n=15 Participants
Children and adolescents with diabetes having blood glucose levels tested using microneedle patches, intravenous (IV) catheter draw, and lancet.
|
|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
16.8 years
STANDARD_DEVIATION 3.2 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline (Hour 1), Hour 2, Hour 3, Hour 4Participants 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.
Outcome measures
| Measure |
Microneedle
n=15 Participants
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.
|
Lancet
n=15 Participants
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.
|
Intravenous Catheter
n=15 Participants
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.
|
|---|---|---|---|
|
Glucose Level
Baseline/Hour 1
|
137 mg/dL
Standard Deviation 119
|
174.5 mg/dL
Standard Deviation 58
|
160.9 mg/dL
Standard Deviation 58
|
|
Glucose Level
Hour 2
|
155 mg/dL
Standard Deviation 78
|
271.4 mg/dL
Standard Deviation 91
|
227.3 mg/dL
Standard Deviation 65
|
|
Glucose Level
Hour 3
|
256 mg/dL
Standard Deviation 224
|
270.4 mg/dL
Standard Deviation 82
|
270.4 mg/dL
Standard Deviation 82
|
|
Glucose Level
Hour 4
|
285 mg/dL
Standard Deviation 126
|
276.4 mg/dL
Standard Deviation 122.9
|
251.5 mg/dL
Standard Deviation 122.9
|
SECONDARY outcome
Timeframe: Baseline ( Hour 1), Hour 4Participants 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.
Outcome measures
| Measure |
Microneedle
n=15 Participants
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.
|
Lancet
n=15 Participants
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.
|
Intravenous Catheter
n=15 Participants
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.
|
|---|---|---|---|
|
Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)
Baseline/Hour 1
|
24.1 units on a scale
Standard Deviation 23.0
|
5.8 units on a scale
Standard Deviation 16.9
|
30.8 units on a scale
Standard Deviation 24.7
|
|
Apprehension Level Assessed by Apprehension Visual Analog Scale (VAS)
Hour 4
|
12.2 units on a scale
Standard Deviation 14.1
|
4.9 units on a scale
Standard Deviation 15.3
|
24.4 units on a scale
Standard Deviation 20.6
|
SECONDARY outcome
Timeframe: Baseline ( Hour 1), Hour 4Participants 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.
Outcome measures
| Measure |
Microneedle
n=15 Participants
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.
|
Lancet
n=15 Participants
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.
|
Intravenous Catheter
n=15 Participants
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.
|
|---|---|---|---|
|
Pain Level Assessed by Pain Visual Analog Scale (VAS)
Hour 4
|
11.2 units on a scale
Standard Deviation 13.5
|
4.4 units on a scale
Standard Deviation 14.4
|
26.8 units on a scale
Standard Deviation 21.1
|
|
Pain Level Assessed by Pain Visual Analog Scale (VAS)
Baseline/Hour 1
|
22.5 units on a scale
Standard Deviation 22.0
|
5.8 units on a scale
Standard Deviation 16.9
|
33.4 units on a scale
Standard Deviation 24.3
|
Adverse Events
Microneedle
Lancet
Intravenous Catheter
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place