PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor
Condition: Type1 Diabetes Mellitus; Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): LabPatch Continuous Glucose Monitoring (CGM)
Intervention type(s): Device
Intervention description(s): The patch device that will be applied to subjects' arms in this study is about 3 inches in length and one inch in width, with adhesive tape on the sides.
The LabPatch circuit chip lies on the underside of the bandage. 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.
A wire that connects the chip to a laptop that continuously captures glucose data.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult subjects with type 1 or type 2 diabetes treated with insulin.
      
Biospecimen description: 
      20 to 22 blood sample( A total of about 110 mL of blood will be drawn during the visit).
    
Keywords: LabPatch Continuous Glucose Monitoring (CGM)