Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03262415
Study type Observational
Source Joslin Diabetes Center
Contact
Status Completed
Phase
Start date February 17, 2017
Completion date May 22, 2019

See also
  Status Clinical Trial Phase
Completed NCT02771093 - An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus Phase 4
Completed NCT02545842 - Assessment Study of Three Different Fasting Plasma Glucose Targets in Chinese Patients With Type 2 Diabetes Mellitus (BEYOND III/FPG GOAL) Phase 4
Recruiting NCT03436212 - Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. N/A
Completed NCT03244800 - A Study to Investigate Different Doses of 0382 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus. Phase 2
Completed NCT03960424 - Diabetes Management Program for Hispanic/Latino N/A
Withdrawn NCT02769091 - A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes Phase 2
Recruiting NCT06065540 - A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor Phase 3
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Completed NCT04091373 - A Study Investigating the Pharmacokinetics of a Single Dose Administration of Cotadutide Phase 1
Completed NCT03296800 - Study to Evaluate Effects of Probenecid, Rifampin and Verapamil on Bexagliflozin in Healthy Subjects Phase 1
Recruiting NCT06212778 - Relationship Between Nutritional Status, Hand Grip Strength, and Fatigue in Hospitalized Older Adults With Type 2 Diabetes Mellitus.
Completed NCT05979519 - Fresh Carts for Mom's to Improve Food Security and Glucose Management N/A
Recruiting NCT05579314 - XW014 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus (T2DM) Phase 1
Completed NCT03859934 - Metabolic Effects of Melatonin Treatment Phase 1
Terminated NCT03684642 - Efficacy and Safety of Efpeglenatide Versus Dulaglutide in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Phase 3
Completed NCT03248401 - Effect of Cilostazol on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes Phase 4
Completed NCT03644134 - A Personalized Intervention to Manage Physiological Stress and Improve Sleep Patterns N/A
Completed NCT05295160 - Fasting-Associated Immune-metabolic Remission of Diabetes N/A
Completed NCT02836873 - Safety and Efficacy of Bexagliflozin in Type 2 Diabetes Mellitus Patients With Moderate Renal Impairment Phase 3
Completed NCT02252224 - Forxiga (Dapagliflozin) Regulatory Postmarketing Surveillance