Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03262415 |
| Other study ID # |
CHS #: 2016-31 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 17, 2017 |
| Est. completion date |
May 22, 2019 |
Study information
| Verified date |
February 2023 |
| Source |
Joslin Diabetes Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to evaluate the accuracy and efficacy of the Cambridge Medical
Technologies, LLC LabPatch Continuous Glucose Monitoring (CGM) System compared to a
laboratory glucose analyzer (YSI 2300 STAT Plus) and 2 commercial glucometers, OneTouch Verio
and Freestyle Lite.
The LabPatch system includes:
1. The LabPatch circuit chip which lies in the center of a circular push-button. The
circuit is in the form of a small chip (approximately 15.7 mm [0.618"] x 15.7 mm
[0.618"]) placed in contact with the skin. The chip has a telescopic micropipette which
draws interstitial fluid to be analyzed for glucose levels. The chip is also able to
measure skin temperature to ensure appropriate skin contact.
2. A Lab Patch holding device (blue box).
3. A wire that connects the chip to a laptop that continuously captures glucose data.
Description:
Study design:
This is a cross-sectional, pilot, precision, single center, single-arm study, enrolling 30
adult subjects with type 1 or type 2 diabetes treated with insulin.
The study will include both a screening visit and a single study visit.The accuracy of the
LabPatch CGM will be evaluated during the study visit, comparing to YSI 2300 STAT Plus,
OneTouch Verio and FreeStyle Lite.
Screening Visit:
Following the informed consent process, screening evaluation will determine subject
eligibility for enrollment, including:
- Demographics- including age, sex at birth, race/ethnicity, dominant hand, and BMI.
- Diabetes History - including type of diabetes, date of diagnosis or length of diabetes,
history of DKA and severe hypoglycemia, current treatment [type of insulin and type of
insulin delivery (injections or insulin pump)], insulin doses, and when applicable:
basal rates, correction factors, glucose targets, insulin duration, insulin to
carbohydrate ratios, sliding scales.
- Current and Past Medical History - including current medications.
- Physical examination and vital signs- including height, weight, blood pressure, pulse,
assessment of venous access for repeated blood draws.
Study Visit (visit window: screening visit + 0 to 30 Days):
Subject Admission
The subject will arrive at the clinical research center at Joslin Diabetes Center during the
day, no later than 10:00 AM and the following will be performed:
- The study team will confirm the absence of fever, nausea or vomiting that might occur
within 24 hours before the visit.
During this visit the following procedures will be conducted:
- Measurement of BP and anthropometric parameters will be taken and include, weight,
height and BMI.
- An intravenous line will be inserted through which all blood samples will be collected.
- The study team will prepare the sensor and its connectors appropriately.
- A fasting blood sample will be collected for measurement plasma glucose, A1C and
complete blood count.
- A breakfast meal will be given followed 3-4 hours later by a lunch.
- Insulin will be injected before breakfast and lunch based on the blood glucose value
before the meal using the same insulin regimen by the subject in the outpatient setting.
- At 15 minute intervals, subject will sit down at a mobile "overbed" table that has the
LabPatch CGM. Then, they will press with their major finger on a circular push-button
for about 15 seconds for each measurement of glucose. When pressed, the LED ring light
illuminates in blue, indicating that the glucose measurement has commenced. The finger
will remain in place until a beep is heard, then lifted.
- Twenty to 22 blood samples will be drawn during the study visit. The samples will be
drawn at the following intervals: baseline, every 15 minutes for 2 hours after
breakfast, every 30 minutes till the lunch time, and every 15 minutes for 2 hours after
lunch. A total of about 110 mL of blood will be drawn during the visit.
- If all admission criteria are not met, the subject will be rescheduled. If all of the
admission readiness conditions are met, the subject will be admitted to the Clinical
Research Center (CRC).
Before discharge:
- Finger-stick glucose will be assessed.
- If plasma glucose is <70 mg/dL, 15 gm of carbohydrates will be given to raise the
glucose to ≥100 mg/dL and blood glucose will be checked after 15 min and another
carbohydrates dose is given if blood glucose is still <70 mg/dL. Subject will be only
allowed to go home when the blood glucose is >100 mg/dL and stable.
Subject Instructions prior to the visit
- Prior to admission, subjects should check their blood glucose, if it is <70 mg/dL or
subject feels hypoglycemic symptoms, then they should eat a snack prior to coming to the
visit
Estimated Visit Duration
- The total duration of the inpatient visit is approximately 6 hours with screening visit
being approximately 2 hour. The study time may be extended for glucose stabilization
prior to discharge.
